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European Patent Office received nearly 200 000 patent applications last year, with 10.1% coming from China China ranks 4th globally in European patent applications Huawei is No.2 among top applicant companies China recorded a 0.5% YoY increase in applications Strongest growth globally came from electrical machinery, apparatus, energy inventions Surge in AI and battery technology patent filings MUNICH and BEIJING, March 27, 2025 /PRNewswire/ -- Chinese companies and researchers filed 20 081 patent applications last year at the European Patent Office (EPO), a new record. China ranks 4th worldwide accounting for 10.1% of total applications at the EPO. This demonstrates the strong presence of Chinese companies in the European technology market. Overall, a total of 199 264 patent applications were filed at the EPO last year from around the world. This high level of patenting activity is comparable to the previous year (2023: 199 452), following three years of significant growth. "Despite political and economic uncertainties, companies and inventors from around the world filed a high number of patents last year, underlining their technological prowess and their continued investment in R&D," said EPO President António Campinos. "The EPO's patent data is a clear roadmap for industry, policy, and investment priorities – tracking global innovation trends and offering insights into European patent application activity across industries and regions." China's innovation momentum remains strong In 2024, China ranked fourth worldwide, after the United States (47,787 applications), Germany (25,033 applications), and Japan (21,062 applications), but ahead of Republic of Korea in fifth place (13,107 applications). Notably, patent applications from China have grown consistently over the past decade: While growth slowed in 2024 (+0.5% compared to 2023), applications from China have more than doubled since 2018; and more than quadrupled since 2014. China's European patent highlights: Huawei tops Chinese applicant list The leading Chinese company was Huawei, which was ranked second at the EPO behind Samsung in 2024, followed by LG, Qualcomm and RTX. The top 10 includes four companies from Europe, two from R. Korea, two from the US, and one from each of China and Japan. In addition to Huawei (4,322 applications), five other Chinese companies ranked in the top 50 applicants at the EPO, showcasing China's robust innovation capabilities and active participation in European patent applications. The rankings include CATL at number 14, with 1,163 European patent applications, ZTE at 16, with 999 applications, Xiaomi at number 20, with 763 applications, Vivo Mobile at 28, with 622 applications and finally Tencent at number 49, with 446 European patent applications. (See graph "Top applicants at the EPO from P.R. China") Computer tech tops EPO patent rankings Computer technology, which includes areas of AI such as machine learning and pattern recognition, was the leading global field at the EPO for the first time, with 16,815 patent applications in 2024. Electrical machinery, apparatus, energy posted the strongest growth last year (+8.9% on 2023), driven by advances in clean energy technologies, particularly battery innovation (+24.0%). Meanwhile, digital communication, which encompasses inventions related to mobile networks, saw a 6.3% decrease. Surge in patents from China in battery technologies For China, the three leading technical fields for European patent filings in 2024 were digital communication, electrical machinery, apparatus, and computer technology — mirroring global trends. The strongest growth from Chinese companies was in electrical machinery, apparatus, energy, which increased by +32.2% in 2024 compared to 2023. This was thanks to a surge from China in patent applications for battery-related technologies (+79%), with four Chinese companies now among the top 15 applicants in battery technologies (up from two in 2023): CATL, Eve Energy, BYD and Zhuhai CosMX Battery. Chinese firms are also becoming active in patenting in a range of other areas, including biotechnology (+15.1%), and organic fine chemistry (+16.1%). Unitary Patent gains in popularity among Chinese patent proprietors The Unitary Patent system, launched in 2023, continues to gain momentum, offering innovators from around the world simpler and more accessible patent protection across 18 EU Member States with a single request to the EPO. Unitary protection was requested for 25.6% of all European patents granted by the EPO in 2024 totalling over 28,000 requests. Patentees from EPO member states had the highest uptake rate, with 36.5% of their European patents transformed into Unitary Patents, followed by those from Republic of Korea (18.9%),China (17.9%, up from 10.9%), the US (16.0%), and Japan (7.9%). Further information View the Patent Index 2024 in full Explore and customise statistics in our Statistics & Trends Centre Access Unitary Patent statistics via our dedicated dashboard Download datasets (MS Excel) in the Download data section of our statistics page Check patent trends on the go with the EPO Data Hub mobile app Read studies on innovation trends at the Observatory on Patents and Technology EPO's support for SMEs, universities, non-profit organisations and other smaller applicants Follow us on social media: X | Facebook | LinkedIn | Instagram | YouTube Official hashtag: #EPOPatentIndex About the EPO With 6 300 staff members, the European Patent Office (EPO) is one of the largest public service institutions in Europe. Headquartered in Munich with offices in Berlin, Brussels, The Hague and Vienna, the EPO was founded with the aim of strengthening co-operation on patents in Europe. Through the EPO's centralised patent granting procedure, inventors are able to obtain high-quality patent protection in up to 45 countries, covering a market of some 700 million people. The EPO is also the world's leading authority in patent information and patent searching.
SHANGHAI and HONG KONG, March 26, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it will release results from four preclinical studies in poster presentations at the 2025 American Association for Cancer Research Annual Meeting (AACR 2025), taking place from April 25th to 30th at the McCormick Place Convention Center, Chicago, the United States. These four posters will feature Antengene's four highly differentiated and high-potential programs, including ATG-201 (CD19 x CD3 TCE) and ATG-042 (MTAPnull-selective PRMT5 Inhibitor), which are poised to enter clinical development in the second half of 2025; ATG-110 (LY6G6D x CD3 TCE), which was developed on the AnTenGagerTM TCE 2.0 platform for the treatment of microsatellite stable colorectal cancer; and a companion diagnostic antibody developed to assess CD24 expression and guide clinical studies of CD24-targeted therapies. Details of the Poster Presentation:ATG-201 (CD19 x CD3 T cell engager)Title: ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseasesAbstract Number: 7326Session Category: ImmunologySession Title: T Cell Engagers and Novel Antibody-Based TherapiesDate: April 30, 2025Time: 9:00 AM - 12:00 PM (Central Time)10:00 PM, April 30, 2025 - 1:00 AM, May 1, 2025 (Beijing Time)Location: Poster Section 40 Introduction: By depleting autoreactive B cells, CD19-targeted CAR-T have shown early yet promising efficacy in treating patients with B cell-driven autoimmune diseases. However, the clinical application of TCE continues to be greatly hindered by the unfavorable pharmacokinetics and toxicity associated with cytokine release syndrome. To overcome these limitations, Antengene developed ATG-201, a "2+1" CD19 x CD3 TCE, which was evaluated in a series of in vitro studies for binding affinity, T cell dependent cytotoxicity (TDCC) cytokine release, and drug developability. The in vivo anti-lymphoma efficacy and pharmacodynamic effect were evaluated in Raji xenograft model. The tissue resident B cell depletion was assessed in CD34+ hematopoietic stem cells humanized mice. Pharmacokinetic parameters of ATG-201 were evaluated in normal Balb/c mice. Results: Compared to benchmark TCEs, ATG-201 demonstrated stronger naïve B cell depletion activity with much lower cytokine release in vitro. ATG-201 showed potent anti-lymphoma activity in PBMC-humanized subcutaneous Raji xenograft model with significant augment of infiltrated CD8+ T cells in tumor microenvironment and limited proinflammatory cytokines detected in plasma. Single dose ATG-201 completely and deeply depleted B cells in blood, bone marrow and spleen of CD34+ cells humanized mice. ATG-201 demonstrated potent efficacy in mouse systemic lupus erythematosus model, inhibiting the lymph node swelling and auto-antibody producing. Conclusions: ATG-201 demonstrated CD19-dependent CD3 binding and activation, inducing effective B cell depletion in vitro and in vivo with low cytokine release, which provides potential for the treatment of B cell malignancies and B cell related autoimmune diseases. ATG-201 is poised to enter clinical development in the second half of 2025. ATG-042 (MTAPnull-selective PRMT5 Inhibitor)Title: Preclinical characterization of ATG-042, a novel MTAPnull-selective PRMT5 inhibitorAbstract Number: 4230Session Category: Experimental and Molecular TherapeuticsSession Title: HDAC and Methyltransferase InhibitorsDate: April 29, 2025Time: 9:00 AM - 12:00 PM (Central Time)10:00 PM, April 29, 2025 - 1:00 AM, April 30, 2025 (Beijing Time)Location: Poster Section 16 Introduction: Targeting the PRMT5-MTA complex has become a promising strategy for treating MTAPnull cancer in a synthetically lethal manner, avoiding on-target off-tumor hematological toxicity when using first-generation, non-selective PRMT5 inhibitors. Herein, Antengene developed ATG-042, a novel MTAPnull-selective PRMT5 small molecule inhibitor with good brain penetration. In this study, the in vitro activity and MTAP selectivity of ATG-042 were profiled using HCT116 MTAP wild type (wt) cells, HCT116 MTAP knock out (ko) cells and multiple endogenous MTAPnull cell lines. The in vivo efficacy was tested in cell derived xenograft (CDX) mouse models with HCT116 MTAP wt cells, HCT116 MTAP ko cells, LU99 cells (MTAPnull) and U87MG-luc (MTAPnull). The pharmacokinetic and toxicological properties were assessed with corresponding assay methods. Results: ATG-042 showed excellent anti-proliferative activities on multiple endogenous MTAPnull cell lines with IC50 values between 10nM and 100nM. ATG-042 demonstrated high permeability, good metabolic stability, and low risk of drug-drug interaction. In vivo PK study shows that ATG-042 is well absorbed, with a dose-dependent increase in plasma distribution and high oral bioavailability in mice, SD rats and beagle dogs. Furthermore, ATG-042 is brain-penetrable (B/P ratio=51% in mice; KPuubrain=0.73 in rats). ATG-042 showed robust in vivo efficacy in both subcutaneous CDX models (HCT116 -MTAP ko, LU99) and orthotopic CDX model (U87MG-luc) as a single agent. In addition, ATG-042 also exhibited potential synergy in combination with other drugs for antitumor therapy. Conclusions: ATG-042 is an oral MTAPnull-selective PRMT5 inhibitor with potent efficacy against MTAPnull tumor. It also demonstrated good tolerability and brain penetrability. ATG-042 is poised to enter clinical development in the second half of 2025. ATG-110 (LY6G6D x CD3 T cell engager)Title: ATG-110, a novel "2+1" LY6G6D-targeted T-cell engager (TCE) for the treatment of MSS colorectal cancerAbstract Number: 3509Session Category: ImmunologySession Title: T Cell EngagersDate: April 28, 2025Time: 2:00 PM - 5:00 PM (Central Time)3:00 AM - 6:00 AM, April 29, 2025 (Beijing Time)Location: Poster Section 38 Introduction: Colorectal cancer (CRC) is one of the most common cancers worldwide and requires more effective and safer therapies to improve the poor survival outcome, particularly in patients with microsatellite stable (MSS) colorectal cancer, who exhibit primary resistance to immune checkpoint inhibitors and lack effective treatment options. T cell engagers have shown encouraging efficacy in treating hematological malignancies, while exhibiting suboptimal clinical efficacies in solid tumors. The risk of cytokine release syndrome (CRS) remains as a significant challenge clinically. ATG-110 is a novel "2+1" LY6G6D x CD3 TCE developed by Antengene. In this study, ATG-110 was evaluated in a series of preclinical in vitro studies for binding affinity, T cell activation and cytokine release, T cell dependent cytotoxicity (TDCC), and drug developability. The in vivo anti-tumor efficacy was evaluated in PBMC-humanized immunodeficient NDG mice engrafted with LY6G6Dmedium-expression HT55 or LY6G6Dvery low-expression SW480 MSS CRC cells. Results: ATG-110 binds to LY6G6D-positive cell lines, including LY6G6D-overexpression 293T, HT55, LS1034, with the nanomolar grade EC50. The CD3 binding site of ATG-110 is concealed by the LY6G6D Fab arm before binding to LY6G6D, due to the steric hindrance. Therefore, ATG-110 demonstrated limited binding capability to CD3+ cells before LY6G6D crosslinking. It activates T cells and induces cytokine release only in the presence of LY6G6D+ cells. In vitro, ATG-110 resulted in potent T cell dependent cytotoxicity with single-digit pM IC50 values on HT55 and SW480 cells. ATG-110 also showed potent anti-tumor activity in PBMC-humanized SW480 xenograft model and exhibited complete response (CR) in PBMC-humanized HT55 xenograft model. Furthermore, ATG-110 also demonstrated good drug developability. Conclusions: ATG-110 demonstrated LY6G6D-dependent CD3 binding and activation with low risk of CRS. It showed powerful in vitro and in vivo anti-tumor efficacy against colorectal cancer, which warrants further clinical evaluation. ATG1144 (CD24 CDx Antibody)Title: Development of a diagnostic antibody for CD24 targeted therapyAbstract Number: 671Session Category: Clinical ResearchSession Title: Diagnostic Biomarkers 2Date: April 27, 2025Time: 2:00 PM - 5:00 PM (Central Time)3:00 AM - 6:00 AM, April 28, 2025 (Beijing Time)Location: Poster Section 29 Introduction: CD24 has emerged as a promising therapeutic target for anti-cancer treatment. Several clinical trials are being conducted to evaluate the safety and efficacy of CD24-targeted therapies. Here, Antengene developed and characterized an anti-CD24 diagnostic antibody to enhance the screening and selection of patients based on CD24 expression. In this study, the authors described the discovery of the diagnostic antibody, and the evaluation of accuracy, sensitivity (selectivity), specificity, and assay precision of the antibody. Results: Monoclonal antibody clone ATG1144 binds to the hCD24 core peptide in ELISA with an EC50 of 0.06 nM. Distinct membrane staining on human normal esophageal tissue FFPE specimens can also be observed with IHC staining using ATG1144. For accuracy assessment, six CDX and twenty human specimens, comprising both positive and negative specimens (including solid tumors and B-cell non-Hodgkin lymphomas), were validated. Samples exhibiting high, medium, and low CD24 expression levels were evaluated for sensitivity and specificity, and the interpreted results aligned with the reference outcomes. FFPE tissues from three distinct patients were evaluated for assay precision assessment. The TMA IHC staining result revealed that 50-80% of patients with lung, breast, bladder, ovarian, or liver cancer have CD24 expression on tumor cell surface with low expression in the para-cancerous normal tissue. Conclusions: ATG1144 specifically binds to human CD24 with high sensitivity as demonstrated by IHC staining. The development and validation of the method have been finalized using Leica Bond III platforms. These data suggest a potential diagnostic use of ATG1144 for identifying CD24+ patients. About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald LungE-mail: Donald.Lung@antengene.com Mobile: +86 18420672158 PR Contacts:Peter Qian E-mail: Peter.Qian@antengene.com Mobile: +86 13062747000
SHANGHAI, March 26, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced its financial results for the full year ended December 31, 2024, along with a corporate update. "In 2024, Everest continued to strength the execution of our 'Dual-Engine' strategy, having evolved from a license-in model to a balanced approach that combines in-house discovery with global partnerships and in-licensing, with a focus on high-value programs and the development of first-in-class or best-in-class assets," commented Rogers Yongqing Luo, CEO of Everest Medicines. "Our total revenue reached RMB706.7 million, representing a 461% year-over-year increase and exceeding our revenue guidance of RMB700 million. Operating expenses as a percentage of revenue decreased significantly by 562%. Notably, our non-IFRS net loss narrowed by 25%, and our gross margin, excluding non-cash items, reached 83%. We ended the year with a strong cash balance of RMB1.6 billion. Importantly, we achieved commercial-level profitability for the full year of 2024. The highlight of our commercial execution in 2024 was the successful launch of NEFECON® in mainland China in May, marking the beginning of a new era in the treatment of IgA nephropathy (IgAN). The product generated RMB353.4 million in revenue for the year, representing a year-over-year increase of 1,581%. NEFECON® was also included in China's National Reimbursement Drug List (NRDL), helping to address a significant unmet medical need among Chinese patients. In addition, it received regulatory approvals in Singapore, Hong Kong SAR, Taiwan region, and South Korea during 2024, expanding its regional footprint in Asia. We also delivered robust growth with XERAVA® (eravacycline), a first-in-class fluorocycline antibiotic, which generated RMB352.8 million in revenue in 2024, representing a 256% year-on-year increase. This strong performance was driven by its differentiated clinical profile and rising market demand. In our autoimmune portfolio, we achieved significant progress with VELSIPITY® (etrasimod), which received regulatory approvals in Macau SAR and Singapore in April 2024. The product was subsequently commercially launched in December in Guangdong province under the 'Hong Kong and Macau Medicine and Equipment Connect' policy. In parallel, New Drug Applications (NDAs) for VELSIPITY® have been officially accepted in both mainland China and Hong Kong in December 2024." "We continued to advance our pipeline of assets with global rights, focusing on creating value in high-potential therapeutic areas. EVER001, a covalent reversible BTK inhibitor, delivered positive results from the preliminary analysis of our Phase 1b/2a trial and is progressing steadily through global development. We also achieved a major milestone by advancing our mRNA platform from early-stage research into global clinical development, underscoring both our innovation capabilities and the strategic potential of our AI-powered mRNA technology. EVM16, our personalized therapeutic mRNA cancer vaccine, completed first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. EVM14, our off-the-shelf tumor-associated antigen (TAA) vaccine, received Investigational New Drug (IND) approval from the U.S. FDA, and we plan to submit an IND application to China's NMPA in the first half of this year. The in vivo CAR-T program is expected to achieve preclinical candidate milestone later this year. These programs are supported by our commercial-scale, GMP-compliant manufacturing facility in Jiashan, Zhejiang, which provides integrated R&D, production, and commercialization capabilities across mRNA and other pipeline platforms. In 2025, we will continue to enhance our commercial excellence and advance our first-in-class and best-in-class assets with global rights to maximize synergies. A key priority will be accelerating the sales of NEFECON®, leveraging its unique position as the only approved IgAN therapy in China and successfully included in the NRDL. With global rights to EVER001, we will actively explore partnership opportunities outside of China to leverage international expertise and optimize commercial value, while further enhancing Everest's global visibility and presence. Our 'Dual-Engine' strategy has entered a new chapter. Under the Board's guidance, Everest will leverage its established efficient commercial platform to solidify our position in key therapeutic areas, advance innovation on our mRNA platform, and strive to become a leading biopharma in the Asia-Pacific region by 2030—delivering greater value for shareholders and breakthrough therapies for patients worldwide." Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO Nefecon® 2024 - In March 2024, the Company's partner Calliditas Therapeutics AB ("Calliditas") (which was acquired by Asahi Kasei Corporation in September 2024 ) announced the U.S. FDA has granted an Orphan Drug exclusivity period of seven years for NEFECON®, expiring in December 2030 based on Calliditas obtaining full approval for this drug product in December 2023. - In March 2024, the Singapore Health Sciences Authority ("HSA") approved NEFEGAN®, known in other Everest territories as NEFECON®, for the treatment of primary IgAN in adults at risk of disease progression. Singapore marks the third region in Everest territories that received NDA approval after Macau and mainland China. - In April 2024, Calliditas published additional sub-analyses of NEFECON®'s Phase 3 NefIgArd study. One of the sub-analyses showed that during the 2-year period (9 months of treatment with NEFECON®, followed by a 15-month observation period after discontinuation), significant benefits in estimated glomerular filtration rate ("eGFR") were observed regardless of baseline UPCR levels (<0.8 g/g or ≥0.8 g/g). This study also showed that patients with UPCR <0.8 g/g who received NEFECON® achieved an eGFR slope of -0.25 mL/min/1.73 m3 per year, supporting the treatment target of <1 ml/min/1.73 m3 per year with the objective to avoid kidney failure in their lifetime. Another sub-analyses demonstrated that, irrespective of baseline UPCR levels and use of rescue medication, time to confirmed 30% eGFR reduction or kidney failure was significantly delayed. - In April 2024, Calliditas announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study for the endpoints of urine protein to creatinine ratio ("UPCR") and eGFRat 9 months in all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. The safety data after 9 months of treatment or retreatment with Nefecon® in patients who completed the NefIgArd study were consistent with previously reported safety data. - In May 2024, the Hong Kong Department of Health had approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories where Nefecon® has received NDA approval after Singapore, Macau and mainland China. - In May 2024, Everest announced the successful launch of NEFECON® in mainland China, which has the highest prevalence of primary glomerular diseases in the world. The commercialization of NEFECON® in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving accessibility to the treatment. - In June 2024, Calliditas announced an additional efficacy analysis of NEFECON® in IgAN at the 61st European Renal Association Congress. An anchored matching-adjusted indirect comparison (MAIC) was performed to estimate the relative effect of NEFECON® or sparsentan on the absolute eGFR change from baseline at 9, 12, and 24 months, with common comparators of optimized renin-angiotensin system inhibition for NefIgArd and irbesartan from the phase 3 PROTECT study. Using patient-level data from NefIgArd and trial-level data from PROTECT, the study demonstrated that treatment with NEFECON® 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years. - In July 2024, China's NMPA accepted the submission of a supplemental New Drug Application seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. - In September 2024, NEFECON® was included in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline notes that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for IgAN patients who are at risk of progressive kidney function loss. - In October 2024, the Taiwan Food and Drug Administration approved NEFECON® indicated "to reduce the loss of kidney function in adult patients with primary IgAN who are at risk for disease progression". Taiwan was the fifth region in Everest Medicines' authorized area to approve NEFECON® after Macau, Mainland China, Singapore, and Hong Kong. - In October 2024, "Kidney 360" magazine published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON® under the title "Efficacy and Safety of Nefecon in Patients with Immunoglobulin A Nephropathy from Mainland China: 2-Year NefIgArd Trial Results". The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the outcomes of global population. - In October 2024, additional analyses of the NefIgArd study for NEFECON® were presented at the 2024 American Society of Nephrology Kidney Week (ASN Kidney Week 2024). One of the analyses showed that the ability of NEFECON® to specifically modulate pathogenic Gd-IgA1 production in the GALT while leaving systemic IgA responses and total IgA and IgG levels unchanged, supports its use as a generally well tolerated, targeted, locally-acting treatment option for IgAN. Another analysis demonstrated that real-world use of NEFECON® was well-tolerated and can reduce loss of kidney function in patients who receive ≥9 months of treatment. - In November 2024, NEFECON® received full approval from the Ministry of Food and Drug Safety ("MFDS") in South Korea, indicated for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). - In November 2024, NEFECON® was included in NRDL in mainland China which takes effect on January 1st, 2025. NEFECON®'s inclusion in the NRDL acknowledges its significant clinical value in improving patient care and with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand in the country. - In December 2024, the first prescription for NEFECON® was issued at Hong Kong Gleneagles Hospital, marking a new era for the targeted treatment of IgAN in the region. It represents the third commercial launch of NEFECON® in the year, following its launch in Mainland China and Singapore. 2025 - On January 1, 2025, with the official implementation of the latest update of NRDL, NRDL pricing now applies to NEFECON® which will benefit more IgAN patients. NEFECON® is the only approved treatment for primary IgAN in adults at risk of disease progression in China. - In March 2025, the HSA has granted full approval of NEFEGAN® indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g)". - We expect to commercially launch NEFECON® in Taiwan region and South Korea in 2025. - We expect to receive NEFECON® full approval from NMPA in 2025. - We expect inclusion of NEFECON® in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in 2025.® EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. 2024 - In December 2024, Everest announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of pMN with EVER001. In an analysis of the data available as of September 13th, 2024, we observed that of the patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission (ICR). In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. 2025 - We expect to report one-year follow up data of the Phase 1b/2a clinical trial in 2025. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) 2024 - In January 2024, eravacycline's clinical breakpoint was officially approved by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST) for clinical use in China. - In November 2024, data on eravacycline (XERAVA®), were presented in Los Angeles, California at IDWeek 2024. The first study evaluated the in vitro antimicrobial activity of eravacycline against Carbapenem-resistant Acinetobacter baumannii (CRAB). Using the recently approved, ChinaCAST breakpoint of 1 µg/mL the results showed a high susceptibility rate of eravacycline against CRAB. The second study evaluated the in vitro activity of eravacycline against 23,127 global clinical isolates of major Gram-positive and Gram-negative bacteria, including drug-resistant strains collected from various regions such as Asia, Europe, and North America from 2018 to 2022. Since its approval in 2018, eravacycline has consistently maintained a high level of susceptibility against clinically relevant pathogens across diverse geographic regions and infection sites which supports eravacycline's use in treating complicated intra-abdominal infections caused by both Gram-negative and Gram-positive bacteria. - In November 2024, in a real-world clinical evaluation led by the National Health Commission's Expert Committee on Clinical Use of Antimicrobials and Evaluation of Antimicrobial Resistance, the final report showed that the overall efficacy rate of eravacycline treatment for 3 days was 91.1%, and the overall treatment efficacy rate at the end of treatment was 90.1%. Cefepime-taniborbactam is an investigational agent that is a combination of cefepime, a fourth-generation cephalosporin, and the novel beta-lactamase inhibitor (BLI), taniborbactam, that exhibits broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam is under development as a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multidrug-resistant Pseudomonas aeruginosa (CRPA/MDR-PA). 2024 - In February 2024, The New England Journal of Medicine ("NEJM") published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections ("cUTI"), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem. 2025 - We expect to submit an NDA for cefepime-taniborbactam in cUTI to China NMPA in 2025. AUTOIMMUNE DISEASE PORTFOLIO VELSIPITY® (etrasimod) 2024 - In February 2024, our licensing partner Pfizer Inc. announced that the European Commission ("EC") granted marketing authorization for VELSIPITY® in the European Union to treat patients 16 years of age and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. - In March 2024, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. In April, the bureau approved the NDA, marking the first approval of VELSIPITY® in Everest territories. - In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia for the treatment of subjects with moderately-to-severely active UC. The data of maintenance treatment confirmed that, after 40 weeks of treatment of 2mg once-daily VELSIPITY or placebo, VELSIPITY® demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of VELSIPITY® was consistent with previous studies, with no new safety signals observed. - In October 2024, Everest announced that, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® was officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and the first prescription for VELSIPITY® was written at Foshan Fosun Chancheng Hospital in Guangdong in December. VELSIPITY® is now Everest's third commercialized product. - In November 2024, the full induction period data results from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia on the treatment of moderately to severely active UC with etrasimod was presented in an oral presentation at the 32nd United European Gastroenterology Week (UEGW 2024). The induction period results showed that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group. The treatment differences in clinical remission, endoscopic improvement, and clinical response rates were 20.4%, 28.6%, and 32.0%, respectively (all P-values <0.0001). Patients treated with etrasimod achieved clinically meaningful and statistically significant improvements in mucosal healing (P<0.0001) and endoscopic normalization (P=0.0003). - In December 2024, the Department of Health of the Government of the Hong Kong Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. - In December 2024, the first prescription of VELSIPITY® in Macau was issued at Kiang Wu Hospital and VELSIPITY® was included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. - In December 2024, the NMPA of China accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC. We expect to receive NDA approval in 2026. 2025 - In February 2025, Everest announced the presentation of maintenance data from its multi-center Phase 3 clinical trial of etrasimod in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). The results demonstrated that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimodtreated patients achieved clinical remission at Week 40 compared with placebo. A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement and clinical response at week 40 compared with placebo. Other secondary endpoints of mucosal healing, endoscopic normalization, and histological remission also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore ≤1 (excluding friability) with a Geboes Index score <2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (2-sided p-value <0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed. - In March 2025, Everest announced the launch of a construction project for etrasimod's local production at Jiashan factory. The project is expected to achieve an annual production capacity of 50 million tablets upon full operation. The planned supply regions include mainland China, Hong Kong, Macau, Taiwan, South Korea, and Singapore, covering Everest's licensing regions in Asia. - We expect to receive VELSIPITY® NDA approval in UC in Hong Kong in 2025. - We expect to submit NDA for VELSIPITY® in UC in Taiwan region and South Korea in 2025. - We will continue to expand VELSIPITY®'s accessibility in the Greater Bay area through the "Hong Kong and Macau Medicine and Equipment Connect" policy in 2025. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for immune- mediated disorders. It was licensed from Kezar Life Sciences in 2023. Everest and Kezar collaborate on the development of zetomipzomib in autoimmune diseases such as autoimmune hepatitis. - In February 2024, Everest announced that the Center for Drug Evaluation ("CDE") of China's NMPA approved Kezar's IND application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis ("LN"). - In July 2024, Everest announced that the first patient had been dosed in China with zetomipzomib in the global Phase 2b PALIZADE trial for the treatment of active LN. - In September 2024, PALIZADE was placed on clinical hold following the recommendation of the Independent Data Monitoring Committee. In October, Kezar made the strategic decision to terminate the PALIZADE trial and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH). - Zetomipzomib is currently being tested in PORTOLA, a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of the molecule in patients with AIH. AIH is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. The study has completed enrollment of 24 patients, and Kezar expects to report topline results in 1H 2025. mRNA PLATFORM Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products including personalized cancer vaccines, tumor-associated antigen vaccines, immunomodulatory cancer vaccines, in vivo CAR-T program, as well as next generation lipid nanoparticle ("LNP") delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global good manufacturing practice ("GMP") standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs. In 2024, the Company advanced its self-developed mRNA pipeline products, the first of which is EVM16, a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. This platform will be an important part of our discovery efforts going forward. 2024 - In Feb. 2024, Everest announced the termination of the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest continues to develop its own therapeutic vaccine products utilizing the mRNA platform. - In August 2024, Everest announced the launch of an IIT for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human ("FIH") trial for EVM16. 2025 - In March 2025, Everest announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. - In March 2025, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a TAA vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. - We expect to submit IND application for EVM14 in China in 2025. PRODUCT PIPELINE Everest has built a strong product pipeline across renal, anti-infective, and autoimmune diseases that are all potentially first-in-class treatment or best-in-class assets. These programs encompass short-term, mid-term and long-term opportunities which are collectively expected to generate significant revenue growth for the Company and create value for its shareholders. Pipeline Outlook 2025 promises to be a year of important data readouts and significant advancement in our best-in-class programs which carry global rights. In 2024 we were pleased to report positive data from a preliminary analysis of a Phase 1b/2a clinical trial of EVER001, a novel BTK Inhibitor for the treatment of primary membranous nephropathy. We expect to advance this trial further in 2025 and plan to report one-year follow-up data in the second half of 2025. Among our self-developed programs, the first patients have been dosed in our IIT for personalized cancer vaccine and preliminary data on safety and immunogenicity are expected this year. In parallel, we have received FDA's IND approval for EVM14, our off-the-shelf TAA cancer vaccine. We also plan to submit IND application to China's NMPA for EVM14 in the first half of this year. It marks the first U.S. IND submission and approval for Everest, and the first IND applications for Everest's self-developed pipeline. With respect to our late-stage programs, we plan to submit the NDA for cefepime-taniborbactam to the NMPA in mainland China for the treatment of cUTI in 2025. We will also submit NDAs for VELSIPITY® in South Korea and Taiwan and expect to receive NDA approval for this product in Hong Kong in the second half of the year. Commercialization Our commercial organization continued to flourish in 2024 as we launched and grew three commercial products, NEFECON®, XERAVA®, and VELSIPITY®. In our renal franchise, our team successfully launched our leading drug product, NEFECON® in mainland China in May 2024. We employed a broad array of sales channels, including traditional in-person detailing of hospitals as well as the innovative channel of online prescribing, to meet the urgent and significant unmet needs of an estimated 5 million IgAN patients. Our 150-person sales team had penetrated more than 600-700 hospitals by the end-of 2024, which encompass over 60% of the addressable IgAN population. To further broaden IgAN patient access, NEFECON® was included in China's 2024 NRDL which went into effect on January 1, 2025. We expect this significantly increased affordability to drive rapid penetration of NEFECON® throughout its patient population. Another highlight for NEFECON® in 2024 was its inclusion in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline points out that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for patients who are at risk of progressive kidney function loss with IgAN. It also suggests that many patients may need either repeated 9-month treatment cycles or a reduced-dose maintenance regimen in order to produce a sustained clinical response in terms of proteinuria reduction or stabilization of eGFR. The safety and efficacy of repeated treatment was also supported by our partner Calliditas' global OLE study which showed consistent treatment response across endpoints of UPCR and eGFR at 9 months across all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. In our anti-infective portfolio, Everest continued to grow XERAVA® sales through deeper penetration of our covered core hospitals and we began partnering with Contract Sales Organizations to benefit patients outside of our core target hospitals, although we still anticipate our own commercial team to generate the majority of sales for XERAVA®. Eravacycline's clinical breakpoint was officially approved by ChinaCAST for clinical use in China, and more than 100 hospitals in China have already adopted the new breakpoint in 2024, facilitating wider use of the drug in clinical practice. Inclusion of eravacycline in the Catalogue of Hierarchical Management of Clinical Application of Antimicrobial Drugs in Shanghai, Beijing and Guangdong last year underscores recognition of the drug's clinical benefits by China's key opinion leaders. In addition, eravacycline was included into The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update and China's Clinical Diagnosis and Treatment Guidelines for Multidrug-resistant Bacterial Infections in Renal Transplantation, Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections and Chinese Expert Consensus on the Diagnosis and Treatment of Pneumonia in the Elderly (2024 Edition). Inclusion in these guidelines is expected to broaden physician awareness of XERAVA® while also encouraging broader product utilization. With the accumulation of clinical experience and the conduct of clinical studies by Chinese doctors, the following articles were published in 2024. These publications have significantly enhanced awareness and provided more references for broader clinical applications. Title Publication Name Publication Date Clinical Analysis of Eracycline in the Treatment of Neurologically Critically Immunosuppressed Patients with Carbapenem-resistant Acinetobacter Baumannii Pneumonia Chinese Journal of Critical Care & Intensive Care Medicine(Electronic Edition) 2024/3/18 Comparison of Efficacy and Safety of Eracycline and Ertapenem in the Treatment of Complicated Intra-abdominal Infections in Chinese Adults Chinese Journal of Infection and Chemotherapy 2024/5/20 Establishment of epidemiological cut-off values for eravacycline,against Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae,Acinetobacter baumannii and Staphylococcus aureus J Antimicrob Chemother 2024/06/14 Research progress of a new antibacterial drug eravacycline Chinese Journal of New Drugs and Clinical Remedies 2024/07/01 Dynamic evolution of ceftazidime-avibactam resistance from a single patient through the IncX3_NDM-5 plasmid transfer and blaKPC mutation International Journal of Antimicrobial Agents 2024/08/01 In vitro antibacterial activity of cefotaxime/avibactam and eravacycline against CRKP Chinese Journal of Clinical Laboratory Science 2024/8/28 Efficacy of eravacycline on pulmonary infection Caused by carbapenem-resistant Acinetobacter baumanni 2024/10/06 Comparison of the efficacy and safety of eravacycline and polymyxin in the treatment of multidrug-resistant complex abdominal infections Natl Med J China 2024/10/15 Efficacy and safety of eravacycline (ERV) in treating infections caused by Gram-negative pathogens: a systematic review and meta-analysis Expert Review Of Anti-infective Therapy 2024/10/22 In vitro activities of the essential antimicrobial agents including aztreonam/avibactam, eravacycline, colistin, and other comparators against carbapenem-resistant bacteria with different carbapenemase genes: a multicenter study in China, 2021 International Journal of Antimicrobial Agents 2024/11/1 Comparative evaluation of eravacycline susceptibility testing methods in 587 clinical carbapenem-resistant Acinetobacter baumannii isolates: broth microdilution, MIC test strip and disc diffusion Journal of Antimicrobial Chemotherapy 2024/11/21 We were pleased to have launched our first autoimmune therapeutic, VELSIPITY® which was approved in Macau in April and in Singapore in May, and successfully launched for sales in those regions. Under the "Hong Kong and Macau Medicine and Equipment Connect" policy ("the Connect Policy"), VELSITPITY® was qualified for early access in nine cities in Guangdong province and its first prescription was written at Foshan Fosun Chancheng Hospital in December. To date, VELSIPITY® has been made available at five designated medical institutions in Guangdong (First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University, Guangzhou United Family Healthcare and Shenzhen Qianhai Shekou Free Trade Zone Hospital) to benefit patients in mainland China with urgent needs for advanced innovative medicines in UC. In 2025 we will continue to build on the strong commercial foundation established in 2024. In our renal franchise, we will work to rapidly ramp NEFECON® sales after its inclusion on the NRDL which makes the medicine much more affordable and broadly accessible to patients. We are targeting rapid progress in NRDL implementation through either hospital listing or dual-channel pharmacies in the first quarter of 2025. We are also aiming to expand our list of core coverage hospitals to about 800 in 2025, which includes over 80% of the potential NEFECON® market with about 200 sales representatives. Everest also anticipates official inclusion of NEFECON® in the 2025 revised Kidney Disease Improving Global Outcomes (KDIGO) guidelines as well as the first Chinese guideline for IgAN as a first-line treatment for IgAN patients. This is expected to help further grow our sales volumes by giving treating physicians an industry standard reference which instills in them more confidence in NEFECON®. While we focus on maximizing the NRDL opportunity in mainland China, we also plan to expand availability of this first-in-disease medication to more IgAN patients across other valuable Asian regions including Taiwan and South Korea. Within our anti-infective portfolio, we will continue to drive penetration of XERAVA® among our core hospitals by enhancing doctors' awareness, which would lead to more prescriptions at hospitals with significant growth potential. We will also drive early and appropriate use of XERAVA® to establish the medicine as a fundamental option in empirical multi-drug resistant bacteria infection therapy. In addition to our own sales network, we will further optimize promotion through the contract sales organization model in non-core markets where we believe XERAVA® prescription can be broadened. VELSIPITY® is our newest launch and in 2025, while we will facilitate the NDA review by NMPA with approval expected in 2026, we will also accelerate its availability in designated medical institutions under the Connect Policy for early access to VELSIPITY® in mainland China. Additionally, VELSIPITY®'s real-world study is planned in Greater Bay to provide physicians with more clinical guidance with the product. Discovery 2024 marked a remarkable year of progress in our mRNA platform as we started the first in-human trial with an investigator-initiated program for our personalized cancer vaccine, EVM16 in two top cancer hospitals in China. EVM16 is independently developed by Everest which contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens, and uses an LNP delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies. We are expecting a catalyst-rich 2025 with a preliminary human data readout from EVM16, for which we achieved first patient dosing in March. Additionally, we have received U.S. FDA's IND approval for EVM14, our off-the-shelf tumor-associated antigen vaccine, marking Everest's first internally discovered program and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. With IND application to China's NMPA expected in the first half of this year, this asset is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. In preclinical studies, EVM14 induced a dosedependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. Lastly, the in vivo CAR-T program is also expected to achieve preclinical candidate milestone later this year, which may create a pathway to future global partnership opportunities. Business Development With the promising data generated by EVER001, our most advanced product with global rights, we will look to potentially engage in out-licensing activities to create value for all our early-stage assets with global rights. For these assets, we plan to pursue global partnership opportunities and seek ways to maximize shareholder value with entities who have global expertise and deals that offer attractive economics. Our business development strategy for in-licensing remains focused on first-in-class or best-in-class assets in less crowded, high value therapeutic areas such as renal diseases, autoimmune disorders, and anti-infective categories. We intend to leverage the strength of our existing commercial platforms to pursue commercial-stage or near-commercial-stage assets in China to create operational synergies and build scale. In parallel, we plan to evaluate earlier-stage assets with global rights, where we can deliver clinical proof-of-concept results and build substantial shareholder value. Financial Highlights IFRS Numbers: Revenue for the year ended 31 December 2024 increased significantly by RMB580.7 million, or 461%, to RMB706.7 million, compared with RMB125.9 million for the year ended 31 December 2023. The revenue growth was primarily driven by the strong ramp up of XERAVA® sales and the successful launch of NEFECON® in mainland China. Additionally, in markets outside of Mainland China, XERAVA® sales continued to build in Hong Kong and Singapore, NEFECON® was successfully launched in Hong Kong and Singapore, and VELSIPITY® was first launched in Macau and made available in Guangdong province through the "Hong Kong and Macau Medicines and Equipment Connect" policy. Gross profit margin rose from 72.7% for the year ended 31 December 2023 to 74.6% for the year ended 31 December 2024. Excluding the amortisation of intangible assets, the gross profit margin increased from 79.9% in 2023 to 82.9% in 2024. The improvement was mainly due to the commercial launch of NEFECON® and the optimisation of product costs. R&D expenses for the year ended 31 December 2024 amounted to RMB528.0 million, decreasing slightly from RMB540.1 million for the year ended 31 December 2023. The Company remains committed to strategic R&D investments across various product pipelines to support long-term sustainable growth. General and administrative expenses increased by RMB84.9 million, from RMB165.2 million for the year ended 31 December 2023 to RMB250.1 million for the year ended 31 December 2024. This increase was primarily due to higher remuneration expenses and professional service expenses in order to support the Company's business expansion and continued pipeline growth. Distribution and selling expenses increased by RMB276.7 million from RMB231.4 million for the year ended 31 December 2023 to RMB508.1 million for the year ended 31 December 2024, primarily due to expansion of the commercial team and additional commercial activities, which helped the successful launch of new products and encouraged the growth of existing product sales. Our commercial operational efficiency increased as commercialization expenses-to-sales ratio decreased by 111.9%, with our continued efforts to build a more efficient and focused commercialization model. The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and selling expenses) to sales decreased by 561.8%, showing operational efficiency improvement. Net loss for the year increased by RMB196.9 million from RMB844.5 million for the year ended 31 December 2023 to RMB1,041.4 million for the year ended 31 December 2024. This increase was primarily due to a one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 vaccines in the first half of 2024. Excluding this impairment loss of an intangible asset, net loss narrowed by RMB107.5 million, from RMB792.5 million for the year ended 31 December 2023 to RMB685.0 million for the year ended 31 December 2024. This was primarily due to the strong product sales and improvements in operational efficiency. Cash and cash equivalents and bank deposits amounted to RMB1,603.3 million as of 31 December 2024. Non-IFRS Measure: Adjusted loss for the year narrowed by RMB176.1 million, from RMB713.6 million for the year ended 31 December 2023 to RMB537.6 million for the year ended 31 December 2024, primarily excluding the one-time and non-recurring loss on impairment of an intangible asset, and non-cash expenses of share-based compensation and amortization of intangible assets. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
SUZHOU, China, March 26, 2025 /PRNewswire/ -- From April 25 to 30, 2025, the American Association for Cancer Research (AACR) Annual Meeting will take place in Chicago. CStone will showcase its latest preclinical studies on five internally developed innovative candidates, including the trispecific antibody CS2009, the bispecific antibody CS2011, and three novel antibody-drug conjugates (ADCs) developed from CStone's proprietary ADC platform: CS5006, CS5007, and CS5005. The abstracts will be published in Cancer Research, the official journal of AACR, on April 11 (ET). CS2009 is a trispecific antibody targeting PD-1, VEGFA, and CTLA-4. Its innovative molecular design is expected to enhance anti-tumor efficacy by preferentially targeting PD-1/CTLA-4 double positive T cells in tumor microenvironment (TME) while reducing systemic toxicity by sparing CTLA-4 single positive cells, making it a potential first-in-class (FIH) or best-in-class (BIC) next-generation immuno-oncology backbone. Preclinical studies have demonstrated that CS2009 induces more potent tumor growth inhibition (TGI) than its potential competitors, such as PD-1/CTLA-4 bispecific antibodies, PD-1/VEGF bispecific antibodies, and PD-1/CTLA-4 combination therapies, along with an outstanding safety profile. CS2009 is currently evaluated in a global multicenter Phase I clinical trial in patients with late-stage cancers, including non-small cell lung cancer (NSCLC), ovarian cancer (OC), renal cell carcinoma (RCC), cervical cancer (CC), hepatocellular carcinoma (HCC), gastric adenocarcinoma (GAC), etc. CS5006 is a first-in-class ADC targeting the novel antigen ITGB4, whose expression pattern holds broad application potential in solid tumors, including NSCLC, squamous cell carcinoma of the head and neck (SCCHN), and esophageal squamous cell carcinoma (ESCC). Preclinical studies demonstrated that ITGB4 ADCs were potent to inhibit tumor growth in multiple animal models and well tolerated, thus supporting further preclinical development toward clinical evaluation of this promising FIC molecule. CS2011 (EGFR/HER3 bispecific antibody) is the bispecific antibody backbone of CS5007 (EGFR/HER3 bispecific ADC). CS2011 enables synergistic blocking of EGFR and HER3 signaling for enhanced therapeutic effects, while minimizing toxicity in normal tissues. CS5007 is built on CStone's proprietary ADC platform, demonstrating best-in-class potential. Both CS2011 and CS5007 target indications include NSCLC, SCCHN, and colorectal cancer (CRC). CS5005 is a first-in-class ADC targeting SSTR2, enabling precise targeting of SSTR2-positive tumors, including small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and neuroendocrine tumors (NETs). CS5005 is composed of CStone's proprietary anti-SSTR2 antibody with high affinity and selectivity, CStone's proprietary hydrophilic beta-glucuronide linker, and potent TOP1 inhibitor. It has demonstrated encouraging anti-tumor activity in vitro and in vivo. Meanwhile, leveraging CStone's proprietary ADC platform, we are accelerating the development of a bispecific ADC targeting SSTR2/DLL3 (CS5008). By simultaneously targeting SSTR2 and DLL3 that frequently co-express in SCLC, NECs, NETs and others, CS5008 aims to overcome tumor heterogeneity, a challenge faced by mono-specific therapies. Detailed information on the research topics and poster presentations selected for AACR 2025 are as follows: Title: CS2009: A first-in-class trispecific antibody targeting PD-1, CTLA-4, and VEGFA with potential to be a next-generation backbone therapy with combined checkpoint inhibition and anti-angiogenesisSession Title: Overcoming Checkpoint Inhibition and Tumor SuppressionPresentation Type: PosterAbstract Number: 7299Time: Wednesday, April 30, 2025, 9:00 AM - 12:00 PM ETLocation: Poster Section 39, Board #14Key Findings: In the proof of mechanism studies, CS2009 demonstrated strong synergy between the PD-1 and CTLA-4 arms, and the checkpoint inhibitory activity from the PD-1/CTLA4 arms was also greatly enhanced through crosslinking between its anti-VEGF arms with VEGFA dimers. DMPK/toxicology study in cynomolgus monkeys demonstrated that the highest non-severely toxic dose (HNSTD) and the no observed adverse effect level (NOAEL) of CS2009 were 100 mg/kg. CS2009 exhibited a PK profile comparable to those of monoclonal antibodies and demonstrated dose-dependent T-cell activation in cynomolgus monkeys. Title: CS5006: A novel integrin β4-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studiesSession Title: Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 2Presentation Type: PosterAbstract Number: 2953Date & Time: Monday, April 28, 2025, 2:00 PM - 5:00 PM ETLocation: Poster Section 18, Board #5Key Findings: CS5006 (ITGB4 ADC) demonstrated promising therapeutic potential by effectively killing tumor cells in both in vivo and in vitro studies, while maintaining a PK profile comparable to those of monoclonal antibodies. Title: CS2011: A novel bispecific antibody targeting EGFR and HER3 that demonstrates promising antitumor activity in preclinical evaluationSession Title: Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 1Presentation Type: PosterAbstract Number: 2927Date and Time: Monday, April 28, 2025, 2:00 PM - 5:00 PM ETLocation: Poster Section 17, Board #1Key Findings: CS2011 (an EGFR/HER3 bispecific antibody), composed of anti-EGFR and anti-HER3 arms with balanced affinity, effectively and synergistically inhibits EGFR/HER3 downstream signaling, leading to further inhibition of tumor growth. Its lead compound demonstrated favorable stability and a PK profile comparable to those of monoclonal antibodies. Title: CS5007: A novel EGFR and HER3 dual-targeted antibody-drug conjugate (ADC) with potent antitumor activity in preclinical studies Session Title: Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 2Presentation Type: PosterAbstract Number: 2954Date and Time: Monday, April 28, 2025, 2:00 PM - 5:00 PM ETLocation: Poster Section 18, Board #6 Key Findings: CS5007 (EGFR/HER3 ADC) inhibited tumor growth by blocking downstream EGFR/HER3 signaling and releasing chemotherapeutic molecules in a target-dependent manner. Its lead compound demonstrated favorable stability and a PK profile comparable to those of monoclonal antibodies. Title: CS5005: A novel SSTR2-targeted antibody-drug conjugate (ADC) with robust antitumor activity in preclinical studiesSession Title: Molecular, Preclinical, and Clinical EndocrinologyPresentation Type: PosterAbstract Number: 4751Date & Time: Tuesday, April 29, 2025, 9:00 AM - 12:00 PM ETLocation: Poster Section 35, Board #18Key Findings: CS5005 (SSTR2 ADC) demonstrated promising therapeutic potential by effectively killing tumor cells in both in vivo and in vitro studies, while maintaining a PK profile comparable to those of monoclonal antibodies. Additionally, a dual-target ADC against DLL3 and SSTR2 also exhibited potential as a therapeutic agent. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit www.cstonepharma.com. Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes.
EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. Preclinical highlights： EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence. In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials. EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy. SHANGHAI, March 24, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens. In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies. "With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling." Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future." According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths1. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases. Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers2, with squamous NSCLC (sq-NSCLC) comprising 25%–30%3. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases4, underscoring the urgent need for new treatment options. Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually5. more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis6, leading to poor prognosis, high mortality rates, and diminished quality of life. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development. Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company's first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale. About EVM14 EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. Reference: 1. Globocan统计数据：https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. 2. Duma, N., R. Santana-Davila, and J.R. Molina, Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clinic Proceedings, 2019. 94(8): p. 1623-1640 3. Socinski, M.A., et al., Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. Journal of Thoracic Oncology, 2018. 13(2): p. 165-183 4. Zhou, C., et al., A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell, 2024. 42(2): p. 198-208.e3 5. Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 1-35. 6. Haddad, R.I., et al., Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol, 2023. 41(12): p. 2166-2180
Fourth-Quarter Revenue Reached RMB11,539 Million, Up 6.9% Year-over-Year 2024 Revenue Reached RMB39,241 Million, Up 5.2% Year-over-Year (Excluding COVID-19 Commercial Project of 2023) Full-Year Net Profit Attributable to the Owners of the Company Reached RMB9,450 Million[1], Diluted Earnings per Share (EPS) of RMB3.26[2] Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company Reached RMB10,583 Million, as 2024 Adjusted Non-IFRS Net Profit Margin Reached Record High of 27.0%; Adjusted Non-IFRS Diluted EPS of RMB3.65 in 2024 Free Cash Flow Achieved Record High of RMB7.98 Billion SHANGHAI, March 17, 2025 /PRNewswire/ -- WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and life sciences industry, today announced financial results for the year ending December 31, 2024 ("Reporting Period"): Revenue reached RMB39,241 million, up 5.2% year-over-year after excluding COVID-19 commercial project in 2023. Adjusted non-IFRS gross profit reached RMB16,326 million. Adjusted non-IFRS gross profit margin was 41.6%. The Company continued to improve operating efficiency, and 2024 adjusted non-IFRS net profit margin reached a record high of 27.0%. Net profit attributable to the owners of the Company was RMB9,450 million; diluted EPS was RMB3.26. Adjusted non-IFRS net profit attributable to the owners of the Company was RMB10,583 million; adjusted diluted non-IFRS EPS was RMB3.65. Driven jointly by continued business growth, efficient operations, and constant improvement of financial management capabilities, free cash flow reached a record high of RMB7.98 billion in 2024. Demand from customers across regions continued to grow. There were ~6,000 active customers at the end of 2024. This included ~5,500 active customers for Continuing Operations, and ~1,000 new customers added in 2024 for Continuing Operations. By the end of 2024, backlog for Continuing Operations reached RMB49.31 billion, growing 47.0% year-over-year. In 2024, revenue from the top 20 global pharmaceutical companies reached RMB16.64 billion, growing 24.1% year-over-year excluding COVID-19 commercial project. The sustained and steady business growth is attributed to our unique fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. WuXi Chemistry's small molecule D&M pipeline has maintained growth, with a total of 1,187 new molecules added in 2024. As of December 31, 2024, our small molecule D&M pipeline reached 3,377 molecules, with an increase of 25 projects in the commercial and phase III stages during 2024. In 2024, our Taixing API manufacturing site commenced operations, and capacity at both Changzhou and Taixing sites steadily increased over the course of the year. Total reactor volume of small molecule APIs is expected to reach over 4,000kL by end of 2025. The total reactor volume of Solid Phase Peptide Synthesizer reached 41,000L as of the end of 2024, and is expected to further increase to over 100,000L by the end of 2025. The Company has been accelerating global capacity expansion. We continued to invest in Couvet, Switzerland site, doubling oral dose manufacturing capacity over the course of 2024. We continued to build the Middletown, Delaware site in the US, which is expected to commence operations by the end of 2026. In May 2024, we broke ground to build the R&D and manufacturing site in Singapore, with its Phase I portion expected to commence operations in 2027. As an enabler of innovation and a trusted partner and contributor to the global pharmaceutical and life sciences industry, the Company actively advanced sustainability and has been consistently recognized by global rating agencies. For four consecutive years, the Company maintained an "AA" rating from MSCI and was named to the S&P Global DJSI Member. In 2024, the Company was improved to EcoVadis "Gold" Rating and CDP Water Security "A" Rating, and joined the United Nations Global Compact (UNGC). Our outstanding performance has also been widely acknowledged by major global rating agencies, including Sustainalytics and FTSE Russell. The Company remains steadfast in our unwavering commitment to guarding customers' IP and adhering to the highest standards for quality and compliance. In 2024, the Company has received a total of 802 quality audits and inspections conducted by global customers, regulatory authorities and independent third parties, and achieved 100% pass rate with no critical findings. Global customers also conducted 58 information security audits, with no critical findings. In addition, 24 of our main operating sites are ISO/IEC 27001 certified, including all main operating sites in China. To ensure that clients and patients with a pressing need for the WuXi ATU cell therapy services can continue to receive time-critical and life-saving treatments without interruption, while valued scientists, technicians and other staff of the WuXi ATU US and UK business can continue to work towards achieving the mission that "every drug can be made and every disease can be treated", the Company signed an agreement to sell the US and UK based operations of WuXi ATU at the end of 2024. In addition, to sharpen our focus on the unique CRDMO to better serve global new drug R&D customers and enhance business synergies across research, development and manufacturing services to better meet the evolving needs of our customers globally, the Company signed an agreement to sell the US medical device testing operations at the end of 2024. As of now, both transactions have been completed. The aforementioned operations, classified as Discontinued Operations in the Company's 2024 Annual Report, collectively contributed revenue of RMB1.32 billion in 2024. [1] Net profit attributable to the owners of the Company is prepared according to Accounting Standard for Business Enterprises of PRC. Due to the different accounting treatment of long-term equity investments under IFRS, net profit attributable to the owners of the Company under IFRS is RMB9,353 million. [2] In 2023 and 2024, WuXi AppTec had a fully-diluted weighted average share count of 2,949,887,619 and 2,893,886,763 ordinary shares, respectively. 2025 Outlook The Company expects Continuing Operations revenue to resume double-digit growth of 10-15% YoY in 2025, targeting to deliver a total revenue of RMB41.5-43.0 billion. The Company will continue to focus on the core CRDMO business, and to improve operating efficiency amid ongoing new capacity release. Adjusted non-IFRS Net Profit Margin expects to further improve in 2025. With the acceleration of global D&M capacity expansion, capex expects to reach RMB7.0-8.0 billion in 2025. Together with business growth and efficiency improvement, free cash flow expects to reach RMB4.0-5.0 billion. While continuously building capacity and capabilities, we remain committed to rewarding shareholders by maintaining an annual cash dividend payout ratio of 30% of net profit attributable to the owners of the Company (~RMB2.8 billion). In appreciation of shareholders' support for our strategic adjustments in challenging times, we propose an additional one-time special cash dividend of RMB1.0 billion and an increased interim dividend in 2025. In addition, the Company plans to repurchase RMB1.0 billion A-share when appropriate. Meanwhile, the Company will continue to invest in talent retention for long-term shared growth. The Company plans to launch the 2025 H-share Incentive Trust Plan, which will grant HKD1.5 billion H-shares upon achieving RMB42.0 billion revenue in 2025, and an additional HKD1.0 billion H-shares upon reaching RMB43.0 billion and above in revenue. H-shares under this plan will be purchased through open market at prevailing market prices (no dilution to existing shareholders). Management Comment Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "The Company remains steadfast in 'doing the right thing and doing it right'. In 2024, we achieved 5.2% year-over-year revenue growth (excluding COVID-19 commercial project of 2023), with all revenue, profit and free cash flow meeting the targets set in our annual guidance. Meanwhile, the backlog for Continuing Operations reached a record high of RMB49.3 billion, representing a 47.0% year-over-year growth." "The Company continues to focus on our unique CRDMO business model, delivering efficient and exceptional services to our global customers and benefiting patients worldwide. Our CRDMO business model enables the Company to generate distinct industry insights and respond promptly to new molecule demands from customers, ensuring the Company's long-term business growth and sustainable returns to shareholders. Entering 2025, the Company will resume its growth trajectory, with Continuing Operations revenue expected to achieve a year-over-year double-digit growth of 10-15%, and the adjusted non-IFRS net profit margin expected to further improve." "Thanks to the enduring trust and support from our global customers, the Company will continue to enhance our capabilities, capacity and operating efficiency, while retaining and attracting top talent to support our customers' growing efforts to bring groundbreaking therapies to patients. Together, we can realize our vision that 'every drug can be made and every disease can be treated'." Business Performance by Segments WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; 2024 Revenue Up 11.2% YoY Excluding COVID-19 Commercial Project of 2023, with TIDES Revenue Up 70.1% YoY WuXi Chemistry Q4 revenue was up 13.0% year-over-year to RMB8.96 billion; 2024 revenue reached RMB29.05 billion, up 11.2% year-over-year excluding COVID-19 commercial project. With continued optimization of production process and constant improvement in efficiency, 2024 adjusted non-IFRS gross profit margin steadily improved 1.2pts year-over-year to 46.4%. Small molecule drug discovery services ("R") continues to generate downstream opportunities. In 2024, we successfully synthesized and delivered more than 460,000 new compounds to customers, which resulted in 10% year-over-year growth. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business. In 2024, 366 molecules were converted from R to D. Small molecule development and manufacturing (D&M) services remains strong.i. 2024 revenue of small molecule D&M services reached RMB17.87 billion, up 6.4% year-over-year excluding COVID-19 commercial project.ii. The small molecule CDMO pipeline continued to expand. In 2024, 1,187 new molecules were added to the small molecule D&M pipeline. As of December 31, 2024, our small molecule D&M pipeline reached 3,377 molecules, including 72 commercial projects, 80 in phase III, 360 in phase II and 2,865 in phase I and pre-clinical stages, with an increase of 25 projects in the commercial and phase III stages during 2024.iii. In 2024, Taixing API site commenced operations, and capacity at both Changzhou and Taixing sites steadily increased over the course of the year. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by end of 2025.iv. We continued to invest in our Switzerland (Couvet) site, doubling oral dose capacity over the course of 2024. Meanwhile, we continued to build our U.S. (Middletown) site, which is expected to commence operations by the end of 2026. In May 2024, we announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027. TIDES business (oligo and peptides) sustains rapid growth.i. 2024 TIDES revenue grew 70.1% year-over-year to RMB5.80 billion. By end of 2024, TIDES backlog was up 103.9% year-over-year.ii. TIDES D&M customers grew 15% year-over-year, while the number of TIDES molecules grew 22% year-over-year.iii. At the end of 2024, total reactor volume of solid phase peptide synthesizers reached 41,000L, and is expected to further increase to over 100,000L by the end of 2025. WuXi Testing[3]: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions Revenue of WuXi Testing reached RMB5.67 billion. Adjusted non-IFRS gross profit margin was 33.3%. 2024 revenue of lab testing services reached RMB3.86 billion, down 8.0% year-over-year due to market impact as pricing gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue was down 13.0% year-over-year, while maintaining an industry-leading position in the Asia-Pacific region. In 2024, the Qidong and Chengdu facilities received the National Medical Products Administration (NMPA) and Organization for Economic Co-operation and Development (OECD) GLP qualifications. The Suzhou facility was reviewed for the first time by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for on-site audit and successfully passed. New modality business continued to develop, while new vaccine capabilities continued to improve, and market share of nucleic acids, conjugates, and mRNA further expanded. The Company is committed to actively enabling customers global licensing. WuXi AppTec has supported approximately 40% of China biotech companies that have made out-licensing deals over the past three years. 2024 revenue of clinical CRO & SMO grew 2.8% year-over-year to RMB1.81 billion. Of which, SMO revenue grew 15.4% year-over-year, maintaining the industry leading position in China. In 2024, Clinical CRO enabled our customers to obtain 29 IND approvals and submit for 1 NDA filing. The SMO business continued steady growth, and supported 73 new drug approvals for customers in 2024. SMO supported 255 new drug approvals in total over the past decade, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer, cardiovascular disease, ophthalmology, rheumatology, central nervous system, medical aesthetics and rare tumors, etc.). [3] As disclosed in 2024 Annual Report, WuXi Testing here includes only the core business of Continuing Operations (similar to 2023 baseline). WuXi Biology: Early Screening & In Vivo Pharmacology-Related Business Drives Growth; WuXi Biology Platform Continues to Generate Downstream Opportunities With platform resources further integrated, WuXi Biology achieved steady quarter-over-quarter growth in 2024. Q4 revenue was up 9.3% quarter-over-quarter and up 9.2% year-over-year. Full-year revenue reached RMB2.54 billion, relatively flat year-over-year. Adjusted non-IFRS gross profit margin was 38.8%. The Company fully leveraged the advantage of one-stop service platform with in vitro & in vivo synergies, 2024 revenue of the non-oncology business grew 29.9% year-over-year, led by growth in metabolic and neurological areas. The Company continued to build a comprehensive and integrated screening platform, with related revenue gaining 18.7% year-over-year. The Company continued to build capabilities related to new modalities, which contributed more than 28% of WuXi Biology's total revenue in 2024. The number of customers and projects served by the nucleic acid platform continued to increase. Cumulatively, the Company has provided services to more than 290 customers, and successfully delivered more than 1,400 projects since 2021. WuXi Biology continued to generate downstream opportunities and contributed over 20% of the Company's new customers. This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2024 Annual Results Presentation and 2024 Annual Report disclosed on the Company's official website, as well as the Company's disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares. Net Profit Attributable to the Owners of the Company is prepared under Accounting Standard for Business Enterprises of PRC ("People's Republic of China Financial Reporting Standards"), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared based on International Financial Reporting Standards (IFRS), in currency of RMB. The 2024 Annual Report of the Company has been audited. 2024 Results by Segments Unit: RMB million Segment Revenue Change Adjusted non-IFRS Gross Profit Change Adjusted non-IFRS Gross Profit Margin WuXi Chemistry 29,052.41 (0.4) % 13,466.65 2.3 % 46.4 % WuXi Testing 5,670.74 (4.8) % 1,888.95 (19.1) % 33.3 % WuXi Biology 2,543.93 (0.3) % 987.23 (8.8) % 38.8 % Others(Note 1) 650.71 (34.7) % 210.16 3.2 % 32.3 % Discontinued Operations (Note 2) 1,323.65 (20.4) % (226.68) (253.3) % (17.1) % Total 39,241.43 (2.7) % 16,326.31 (3.6) % 41.6 % Note 1: Others comprise the non-core business of the company, as well as income from administrative services, sales of raw materials and sales of scrap materials. Note 2: By the end of 2024, the Company has signed an agreement to sell the US and UK based operations of WuXi ATU and the US medical device testing operations. According to IFRS, the aforementioned businesses are classified as discontinued operations. The Company completed the sales of the US and UK based operations of WuXi ATU and the US medical device testing operations as at the date of the report. Note 3: Any sum of the data above that is inconsistent with the total is due to rounding. Consolidated Statement of Profit or Loss[4] – Prepared under IFRS RMB Million Year Ended December 31, 2024 Year Ended December 31, 2023 Revenue 39,241.4 40,340.8 Cost of sales (23,225.3) (23,968.3) Gross profit 16,016.1 16,372.5 Other income 1,146.1 962.5 Other gains and losses 804.4 1,350.3 Impairment losses under expected credit losses ("ECL") model, net of reversal (334.3) (240.9) Impairment losses of non-financial assets (115.6) (67.4) Impairment losses of goodwill (110.4) (49.6) Impairment losses of assets classified as held for sale (948.4) - Selling and marketing expenses (745.4) (701.0) Administrative expenses (3,009.5) (2,994.9) R&D expenses (1,238.5) (1,440.6) Operating Profit 11,464.5 13,190.7 Share of results of associates 252.1 (35.1) Share of results of joint ventures (7.1) (32.5) Finance costs (268.6) (193.6) Profit before tax 11,441.0 12,929.6 Income tax expense (1,972.1) (2,131.7) Profit for the year 9,469.0 10,797.9 Profit for the year attributable to: Owners of the Company 9,352.6 10,690.2 Non-controlling interests 116.3 107.7 9,469.0 10,797.9 Consolidated Statement of Profit or Loss (continued) – Prepared under IFRS Year Ended December 31, 2024 Year Ended December 31, 2023 Weighted average number of ordinary shares for calculating EPS (express in shares) – Basic 2,885,200,544 2,934,188,474 – Diluted 2,893,886,763 2,949,887,619 Earnings per share (expressed in RMB per Share) – Basic 3.24 3.64 – Diluted 3.22 3.61 [4] If the sum of the data below is inconsistent with the total, it is caused by rounding Consolidated Statement of Financial Position[5] – Prepared under IFRS RMB Million December 31, December 31, 2024 2023 Non-current Assets Property, plant and equipment 25,267.8 25,844.4 Right-of-use assets 1,874.8 2,348.3 Goodwill 972.4 1,820.9 Other intangible assets 601.0 906.7 Interests in associates 2,322.2 2,180.4 Interests in joint ventures 3.4 35.2 Deferred tax assets 473.1 366.7 Financial assets at fair value through profit or loss ("FVTPL") 8,943.4 8,626.0 Other non-current assets 114.7 105.8 Biological assets 1,063.0 1,012.5 Total Non-current Assets 41,635.7 43,246.9 Current Assets Inventories 3,532.1 2,886.1 Contract costs 912.2 695.6 Biological assets 955.5 1,154.6 Amounts due from related parties 89.3 86.7 Trade and other receivables 9,643.7 9,372.7 Contract assets 988.8 1,234.4 Income tax recoverable 87.2 17.5 Financial assets at FVTPL 1,234.0 11.0 Derivative financial instruments - 414.0 Other current assets 734.1 785.8 Pledged bank deposits 22.1 1.6 Term deposits with initial term of over three months 4,865.6 3,761.4 Bank balances and cash 13,434.3 10,001.0 36,498.8 30,422.5 Assets classified as held for sale 2,191.3 - Total Current Assets 38,690.2 30,422.5 Total Assets 80,325.8 73,669.3 Consolidated Statement of Financial Position (continued) [6]– Prepared under IFRS RMB Million December 31, December 31, 2024 2023 Current Liabilities Trade and other payables 7,025.5 7,333.5 Amounts due to related parties 15.3 11.5 Derivative financial instruments 202.0 501.9 Contract liabilities 2,251.0 1,955.4 Bank borrowings 1,278.6 3,721.6 Lease liabilities 224.2 240.5 Income tax payables 870.8 991.9 Convertible bonds 3,493.1 - 15,360.6 14,756.3 Liabilities associated with assets classified as held for sale 865.5 - Total Current Liabilities 16,226.1 14,756.3 Non-current Liabilities Bank borrowings 2,959.5 687.0 Deferred tax liabilities 522.4 530.1 Deferred income 985.6 1,079.9 Lease liabilities 546.6 1,098.6 Total Non-current Liabilities 5,014.1 3,395.6 Total Liabilities 21,240.2 18,151.9 Net Assets 59,085.6 55,517.4 Capital and Reserves Share capital 2,888.0 2,968.8 Reserves 55,744.7 52,153.6 Equity attributable to owners of the Company 58,632.7 55,122.5 Non-controlling interests 452.9 395.0 Total Equity 59,085.6 55,517.4 [5] If the sum of the data below is inconsistent with the total, it is caused by rounding [6] If the sum of the data below is inconsistent with the total, it is caused by rounding Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[7] RMB Million Year Ended December 31, Year Ended December 31, 2024 2023 Net profit attributable to the owners of the Company under PRC 9,450.3 9,606.7 GAAP difference[8] (97.7) 1,083.4 Net profit attributable to the owners of the Company under IFRS 9,352.6 10,690.2 Add: Share-based compensation expenses 307.0 622.0 Issuance expenses of convertible bonds 7.8 0.3 Fair value gain from derivative component of convertible bonds - (40.2) Foreign exchange related losses 29.6 294.4 Amortization of acquired intangible assets from merge and acquisition 53.5 57.9 Losses from impairment and disposal of non-financial assets 134.1 129.1 Losses from divestiture and restructuring initiatives 1,165.0 - Talent incentive and retention expenses funded by cash donation from shareholders 151.3 151.5 Non-IFRS net profit attributable to the owners of the Company 11,200.9 11,905.2 Add: Realized and unrealized gains from venture capital investments (625.5) (1,083.0) Realized and unrealized share of losses from joint ventures 7.1 32.5 Adjusted non-IFRS net profit attributable to the owners of the Company 10,582.5 10,854.6 [7] If the sum of the data below is inconsistent with the total, it is caused by rounding [8] Due to the different accounting treatment of long-term equity investments under IFRS, it occurs GAAP difference of RMB(97.7) million. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com Forward-Looking Statements This press release may contain certain statements that are or may be forward looking, which can be recognized by the use of words such as "expects", "plans", "will", "estimates", "projects", "intends", or words of similar meaning. Such forward-looking statements are not historical facts, but instead are predictions about future events based on our beliefs, development strategy, business plan as well as assumptions made by and information currently available to our management. Although we believe that our predictions are reasonable, future events are inherently uncertain and our forward-looking statements may turn out to be incorrect. Our forward-looking statements are subject to risks relating to, among other things, the ability of our service offerings to compete effectively, our ability to meet timelines for the expansion of our service offerings or production capacity, our ability to reach the scale of our production capacity expansion plans, our ability to protect our clients' intellectual property, competition, unforeseeable change of international policy, the impact of emergencies and other force majeure. Our forward-looking statements do not constitute any profit forecast by our management nor a undertaking by WuXi AppTec Co., Ltd. ("WuXi AppTec" or the "Company") to our investors. ACCORDINGLY, YOU ARE STRONGLY CAUTIONED THAT RELIANCE ON ANY FORWARD-LOOKING STATEMENTS INVOLVES KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement or information in this press release to reflect future events or circumstances, except as required under applicable law. Continuing Operations and Discontinued Operations The Company has signed share purchase agreement to sell the US and UK based operations of WuXi ATU and the US medical device testing operations by the end of 2024. In accordance with the International Financial Reporting Standards ("IFRS"), the aforementioned operations shall be classified as discontinued operations ("Discontinued Operations"). The remaining operations of the Company will continue to be reported as continuing operations ("Continuing Operations"). Use of Non-IFRS and Adjusted Non-IFRS Financial Measures We provide non-IFRS gross profit and non-IFRS net profit attributable to the owners of the Company, which exclude share-based compensation expenses, issuance expenses of convertible bonds, fair value gain or loss from derivative component of convertible bonds, foreign exchange-related gains or losses and amortization of acquired intangible assets from merger and acquisition, non-financial assets impairment, losses from divestiture and restructuring initiatives, etc. We also provide adjusted non-IFRS net profit attributable to the owners of the Company and earnings per share, which further exclude realized and unrealized gains or losses from our venture capital investments and joint ventures. Neither of the above is required by, or presented in accordance with IFRS. We believe that the adjusted financial measures used in this presentation are useful for understanding and assessing our core business performance and operating trends, and we believe that management and investors may benefit from referring to these adjusted financial measures in assessing our financial performance by eliminating the impact of certain unusual, non-recurring, non-cash and non-operating items that we do not consider indicative of the performance of our core business. Such non-IFRS financial measures, the management of the Company believes, is widely accepted and adopted in the industry the Company is operating in. However, the presentation of these adjusted non-IFRS financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with IFRS. You should not view adjusted results on a stand-alone basis or as a substitute for results under IFRS, or as being comparable to results reported or forecasted by other companies.
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