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
PISCATAWAY, N.J., March 26, 2025 /PRNewswire/ -- GenScript Biotech Corporation (GenScript), a global leader in life sciences research, manufacturing technologies and production services, has been awarded the EcoVadis Bronze Medal for the second year in a row, recognizing its strong sustainability performance. This achievement reflects GenScript's continued progress in environmental stewardship, labor and human rights, ethics, and sustainable procurement, reaffirming its commitment to global best practices. This year, GenScript ranked ahead of 83% of all companies assessed by EcoVadis and placed in the top 10% in the manufacture of basic pharmaceutical products and pharmaceutical preparations industry—a significant improvement from its previous assessment. This milestone further underscores GenScript's dedication to sustainability and its role as a trusted partner for the global life science and healthcare ecosystem. "We are proud to receive the EcoVadis Bronze Medal for the second consecutive year with significant improvement in our performance. This recognition underscores our unwavering commitment to sustainability and responsible business practices," said Sherry Shao, Rotating CEO of GenScript Biotech Corporation. "At GenScript, we believe that sustainability is not just a goal, but a fundamental part of our mission to make people and nature healthier through biotechnology. By optimizing operations and collaborating with our value chain, we have taken steps forward in reducing environmental impact, promoting ethical practices, and fostering social responsibility over the past year. We will build on this momentum and work with global business partners to create long-term value." EcoVadis, a globally recognized sustainability rating platform, evaluates companies based on international standards, including the Global Reporting Initiative (GRI), the United Nations Global Compact (UNGC), and ISO 26000. Covering over 220 industries and more than 180 countries and regions, its assessments measure corporate sustainability performance across environmental impact, labor and human rights, business ethics, and sustainable procurement. Beyond EcoVadis, GenScript's sustainability efforts have received broader global recognition. In 2023, GenScript joined the United Nations Global Compact (UNGC), committing to the Ten Principles on human rights, labor, environment, and anti-corruption. In 2024, GenScript and its subsidiary, ProBio, strengthened their sustainability commitments by becoming supplier partners of the Pharmaceutical Supply Chain Initiative (PSCI), contributing to a greener and more ethical pharmaceutical supply chain. In capital markets, GenScript's ESG initiatives have also been highly recognized, with its MSCI ESG rating improving from BBB to A, reflecting its strong environmental, social, and governance (ESG) performance. Additionally, in February 2025, GenScript's carbon reduction targets were officially validated by the Science Based Targets initiative (SBTi), marking a major milestone in the company's global decarbonization journey. Looking ahead, GenScript remains committed to embedding sustainability into its DNA, continuing to innovate and collaborate to advance the long-term health of both society and the planet. About GenScript Biotech Corporation Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in healthcare and consumer goods by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology and its role as a trusted global leader, GenScript has a team of over 5,500 employees and has served more than 200,000 customers across over 100 countries and regions. Learn more here: https://www.genscript.com
SINGAPORE, March 26, 2025 /PRNewswire/ -- Gene Solutions, a leading biotech company in Asia, proudly announces a groundbreaking achievement in cancer early detection. The company's innovative SPOT-MAS test has become the first multi-cancer screening blood test in Asia to complete large prospective cohort validation, as published in BMC Medicine. This milestone marks a major advancement, enabling large-scale, non-invasive early detection. Gene Solutions Leads the Way in Cancer Early Detection with Asia’s First Clinical Validated Multi-Cancer Blood Test Addressing a Critical Need Common cancers like breast and colorectal have survival rates greater than 90% if detected early (1). However, over 70% of cancers in low- and middle-income Asian countries are diagnosed at a late stage (2). Conventional image-based screening has limitations, including being invasive, less accessible, and focused on a single organ, which can lead to a high cumulative false positive rate when performed sequentially (3). SPOT-MAS aims to improve this by providing a reliable, non-invasive, multi-cancer blood test. The test incorporates next-generation sequencing (NGS) and artificial intelligence technologies to detect circulating tumor DNA (ctDNA) released from cancer cells into the bloodstream. Previously, SPOT-MAS established laboratory technology and analytical validation from 2018 to 2021. From 2022 to 2024, the SPOT-MAS test underwent the landmark K-DETEK Trial. This trial was the first and largest prospective cancer screening study in Asia, where 9,057 asymptomatic individuals were followed up for 12 months. After exclusions, 9,024 participants were analyzed, with 42.27% classified as high-risk due to factors such as smoking, alcohol consumption, and hepatitis virus infection. The Third Worldwide and the First Clinically Validated Multi-Cancer Early Detection (MCED) Test in Asia: While two other MCED tests have undergone prospective validation in the United States, the K-DETEK trial uniquely offers clinical data tailored to the Asian population. Despite the high expectations surrounding MCED tests worldwide, one of the most significant challenges is preserving performance when transitioning from controlled studies to real-world clinical validation. The SPOT-MAS test rises this challenge, demonstrating consistent performance across various validation studies. These include a case-control study with 2,288 participants published in eLife, the K-DETEK clinical trial with 9,024 participants published in BMC Medicine, and a real-world experience report of 10,577 tests conducted across Southeast Asia (Vietnam, Singapore, Malaysia, Thailand, Indonesia, and the Philippines) in ESMO Annals of Oncology (4,5,6). Additionally, the trial highlights the test's ability to detect precancerous lesions in the colon, offering opportunities for early intervention and active prevention of colorectal cancer. Remarkable Data from the Trial (5,7): High Sensitivity and Specificity: The SPOT-MAS assay demonstrated an overall sensitivity of 70.8% for cancerous lesions and 78.1% when combined with the assessment of precancerous lesions in the digestive tract, with a specificity of 99.7% for detecting various cancer types. Remarkable Predictive Value: The trial showed a positive predictive value of 39.53% for cancerous cases and 58.1% when including both cancerous and precancerous cases. The tumor origin prediction, based on the algorithm and machine learning model, had an accuracy of 52.9% for cancerous lesions and 84.0% when combined with precancerous lesions. The negative predictive value was an impressive 99.92%, ensuring accurate screening while minimizing unnecessary follow-ups. "SPOT-MAS is the first MCED test in Asia to provide real-world clinical evidence for cancer screening, offering the validation data needed for region-specific populations and demonstrating the test's clinical utility. We believe this important milestone will foster more discussions with regional healthcare experts to implement the test in routine medical screening programs." said MD. PhD. Nguyen Duy Sinh, Oncology Medical Director at Gene Solutions. Innovative Multi-Omics & Artificial Intelligence Approach Most MCED tests focus on a single circulating tumor DNA (ctDNA) biomarker detected through Next-Generation Sequencing technology. SPOT-MAS employs an innovative multi-omics analysis approach that integrates genetic, fragmentomic, and epigenetic features of ctDNA. This comprehensive strategy enhances cancer type coverage and improves real-world accuracy. The bioinformaticians behind the SPOT-MAS test leverage artificial intelligence (AI) to analyze the extensive data generated from these comprehensive features. By developing multiple machine learning, deep learning, and neural network models, they continuously train on labeled data from healthy individuals and cancer patients. This multi-modal AI technology further improves test sensitivity, accurately classifies cancer origins, and optimizes cost-efficiency for the multi-omics analysis approach. Future Innovations and Collaborations The SPOT-MAS test has demonstrated strong performance in detecting deadly cancers that lack standard screening options, such as cancers of the stomach, liver-biliary tract, ovary, pancreas, esophagus, endometrium, and head & neck. It also complements existing screening strategies for breast, colorectal, and lung cancers. With this successful validation, Gene Solutions is moving forward with plans to integrate SPOT-MAS into daily clinical practice. The company is collaborating with leading hospitals, regulators, and research institutions to expand access and adoption in both public and private healthcare sectors. As shared in a recent interview with GenomeWeb(8), Dr. Tran Le Son, R&D Lead at Gene Solutions, outlined the upcoming plans for the technology: Ongoing and Planned Studies: Gene Solutions is conducting and planning several additional studies, including a multicenter validation study similar to K-DETEK but focused on symptomatic individuals suspected of having cancer. "In this study, we aim to validate the test's effectiveness in a high-risk diagnostic population. We plan to complete the study and submit a manuscript by the end of this year," Dr. Tran explained. SPOT-MAS Lung and SPOT-MAS CRC: Another multicenter validation study is planned in Singapore to assess the effectiveness of the SPOT-MAS Lung test in detecting lung cancer in both screening and diagnostic populations. Like the SPOT-MAS MCED test, the single-cancer assays analyze ctDNA for genetic, fragmentomic, and epigenetic features, with an optimized focus on signals specific to lung cancer or colorectal cancer. The single-cancer approach is expected to offer significant clinical advantages in specific scenarios. For instance, when a specific cancer is strongly suspected, a test tailored exclusively for that cancer will be more cost-effective and deliver superior screening performance, such as higher sensitivity and specificity, compared to broader screening methods. Biopharma Collaborations: "Looking ahead, we are eager to collaborate more with biopharma companies," Dr. Tran shared. Gene Solutions aims to leverage its proprietary artificial intelligence platform and Asia-centric genomic advantages to discover biomarkers and therapeutic targets for personalized cancer treatments and cancer vaccines. About Gene SolutionsGene Solutions, a multinational biotech company in Asia, is leading the way in leveraging advanced AI and ctDNA technologies for innovative cancer detection solutions. The company partners with over 4,500 hospitals and clinics across Southeast Asia and boasts a team of approximately 250 biology experts and technicians out of a total of 700 employees. Gene Solutions has published more than 50 peer-reviewed publications and conducted over 50 multi-center studies across the region. The company, recognized for its proprietary research and CAP-accredited laboratories in Singapore and Vietnam, combines multi-dimensional genomics with AI-driven approaches to transform cancer care. References:(1) Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2022 and Cancer Facts & Figures 2021; the ACS website; and the International Agency for Cancer Research website. (2) Sankaranarayanan, R., Ramadas, K., Qiao, Y., 2014. Managing the changing burden of cancer in Asia. BMC Med 12, 3. (3) Imai, M., Nakamura, Y., & Yoshino, T. (2025). Transforming cancer screening: the potential of multi-cancer early detection (MCED) technologies. International Journal of Clinical Oncology.(4) Le Son Tran et al (2023) Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization eLife 12:RP89083. (5) Nguyen, L. H. D., et al. (2025). Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults. BMC Medicine, 23(1). (6) Annals of Oncology (2024) 35 (suppl_4): S1679-S1697. (7) Carbonell, Chantelle, et al. Cancer Control 31 (2024).(8) Genomeweb.com Gene Solutions Looks to Expand MCED Test Market After Strong Validation Data (19 Feb 2025).
CHENGDU, China, March 26, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration. SKB107 is the first company RDC drug clinical project. SKB107 is jointly developed by the Company and Professor Chen Yue's team of the Affiliated Hospital of Southwest Medical University (the "Affiliated Hospital of SMU"). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023. About Bone Metastasis of Malignant Tumors Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors[1]. Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients' quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients' quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients' survival, and the development of new mechanisms of action and safer and more effective drugs is imminent. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/. Reference [1] [Bone Tumour Group of the Chinese Orthopaedic Association（2009）] Expert consensus on the surgical treatment of bone metastases. Chinese Journal of Orthopaedics;29(12):1177-1184.
Accelerates Globalization of Innovative Products with Operating Cash Flow Surging 31.13% YoY SHANGHAI, March 26, 2025 /PRNewswire/ -- On March 25, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading global pharmaceutical and healthcare company driven by innovation, announced its annual results for the year ended 31 December 2024 ("the Reporting Period"). In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit. In addition, Fosun Pharma continues to advance lean management across quality enhancement, cost control, efficiency improvement, cycle management, and innovation R&D, driving operational efficiency and expanding profitability. During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million. Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. During the Reporting Period, Fosun Pharma continuously optimized its innovative R&D system while maintaining stable R&D investment, focusing on key pipeline strengths and enhancing efficiency through system integration. In 2024, Fosun Pharma's total R&D expenditure amounted to RMB5.55 billion, with R&D expenses totaling RMB3.64 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB4.91 billion, accounting for 16.98% of pharmaceutical business revenue. There are over 80 major pipeline projects on innovative drugs and biosimilars (calculated by indications). In addition, during the Reporting Period, the pharmaceutical manufacturing segment of Fosun Pharma submitted 220 patent applications, including 3 American patent applications, 18 PCT applications, and Fosun Pharma has obtained 66 licensed invention patents authorization. Accelerating Innovation Transformation and the Internationalization of Innovative Products Focusing on unmet clinical needs, Fosun Pharma continuous to push forward its innovation transformation and the development and commercialization of innovative products, expanding into regulatory markets such as the U.S. and the EU. During the Reporting Period, 7 innovative products/biosimilars with a total of 16 indications independently developed and licensed-in by Fosun Pharma were approved for launch, and 8 innovative products/biosimilars had entered the pre-launch approval/critical clinical stage. Fosun Pharma also had 18 innovative products/biosimilar projects (calculated by indications) initiated clinical trials. In the field of lung cancer, Fosun Pharma has developed a comprehensive layout in innovative drugs and precision diagnostics and treatment to benefit patients globally. Fosun Pharma's self-developed innovative anti-PD-1 monoclonal antibody, Han Si Zhuang (Serplulimab Injection), is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), and it remains the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. During the Reporting Period, Han Si Zhuang also received approval in Chinese mainland for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), and this also marked its third indication in the field of lung cancer, further expanding its reach. To date, Han Si Zhuang has been approved for marketing in over 30 countries and regions, including China, the European Union, and several Southeast Asian nations, benefiting more than 100,000 patients. In addition, to help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way, the Ion Bronchial Navigation Operation Control System (Ion System) of Intuitive Fosun, Fosun Pharma's associated company, received NMPA approval in March 2024 and has been commercially deployed. In high-incidence cancers such as breast and gastric cancers, Fosun Pharma's self-developed monoclonal antibody(mAb) biosimilar Han Qu You (Trastuzumab Injection) has been approved for launch in over 50 countries and regions, including China, the European Union, the U.S., Canada and Australia, and has been included in the health insurance directories in countries such as China, UK, France, and Germany. To date, Han Qu You has benefited over 240,000 patients. The HER2-targeted innovative monoclonal antibody HLX22 for gastric cancer treatment and the novel endocrine therapy HLX78 (lasofoxifene) for breast cancer are currently under international multi-center Phase III clinical trials. Additionally, the biosimilar candidate HLX11 (pertuzumab) has had its new drug applications submitted and accepted in both China and the U.S., injecting new momentum into global expansion. In addition, Fosun Pharma is also advancing the development of rare disease drugs. Its self-developed MEK1/2 selective inhibitor Luvometinib tablets, (Project Code: FCN-159), has had its new drug applications for two indications—treatment of adult dendritic cell and histiocytic tumors, and treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1) in children aged 2 years and older—accepted by the NMPA and placed in the priority review process. In the non-oncology field, during the Reporting Period, Fosun Pharma's self-developed and licensed-in rabies vaccine (Vero cell) for human use (freeze dried), Pu Rui Ni (Pretomanid Tablets), Han Da Yuan (Adalimumab Injection) received approval for four new indications, and Su ke Xin (Avatrombopag Malate Tablets) was approved for its second indication in China; meanwhile, the new drug applications for a biosimilar of denosumab HLX14 under development were accepted by the European Medicines Agency (EMA), Health Canada and the FDA, respectively. Continuously Enhancing Global Operations and Bilateral Licensing Cooperation Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, overseas revenue reached RMB11.30 billion, accounting for 27.51% of total revenue. During the reporting period, Fosun Pharma continues to promote the building of production system with international quality standard, laying a solid foundation for the overseas distribution of preparations. As of the end of 2024, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of Fosun Pharma obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. Fosun Pharma's pharmaceuticals and medical devices businesses now primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia, with an overseas commercialization team of over 1,000 employees. In the U.S., Fosun Pharma's in-house generic drug team has continued to grow, establishing partnerships with major distributors and group purchasing organizations (GPOs) to drive the sales of formulation products. Meanwhile, Fosun Pharma has established its innovative drug team in the U.S. and is preparing for the commercialization of its anti-PD-1 monoclonal antibody (mAb), serplulimab injection. In Europe, Gland Pharma has built localized manufacturing capabilities through its subsidiary, Cenexi. Sisram Medical has expanded its global direct sales offices to 12, with its marketing network now covering over 110 countries and regions. The share of direct sales revenue has further increased to 87%. Meanwhile, Breas Medical's marketing network has expanded across key mature markets, including Europe, the United States, Japan, and Australia. In emerging markets, Fosun Pharma's sales network in Africa now covers over 40 countries and regions. The company continues to advance the Côte d'Ivoire park project to establish localized pharmaceutical manufacturing and supply in Africa. In February 2025, Fosun Pharma launched a new pharmaceutical and medical device sales platform in Nanning, gradually enhancing its registration and commercialization capabilities in Southeast Asia to expand its presence in the region. Fosun Pharma is also actively expanding into the Middle East market. During the reporting period, Henlius, a subsidiary of Fosun Pharma, entered into a strategic partnership with SVAX to establish a joint venture in Saudi Arabia. This collaboration aims to enhance the accessibility of innovative and high-value products in the MENAT region (Middle East, North Africa, and Turkey). Fosun Pharma continues to strengthen its global licensing collaboration, further enhancing its international influence and competitiveness. On the out-licensing front, Henlius, a subsidiary of Fosun Pharma has forged deep partnerships with over 20 leading global biopharmaceutical companies, including Accord, Abbott, Eurofarma, KGbio, Organon, and Dr. Reddy's, to jointly expand global markets. These collaborations comprehensively cover major biologics markets in Europe and the U.S., as well as numerous emerging markets. To date, its approved biologics have benefited more than 750,000 patients worldwide. Fosun Pharma continues to expand its product pipeline in core therapeutic areas through strategic global collaborations. Licensed-in products such as the antiemetic Akynzeo® (netupitant/palonosetron capsules), long-lasting recombinant human granulocyte colony-stimulating factor product (Pei Jin) and the drug for heart failure and hypertension treatment (Yi Xin Tan) have been included in the National Medical Insurance Drugs Catalogue, benefiting a wide range of patients. Fosun Pharma has obtained exclusive development and commercialization rights for Tenapanor Hydrochloride Tablets (Wan Ti Le), a first-in-class phosphate-lowering drug with a novel mechanism. In February 2025, the drug received approval from the National Medical Products Administration (NMPA) in China for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease (CKD). This approval marks a new era of multi-mechanism phosphate control, bringing new hope to dialysis patients with hyperphosphatemia. During the reporting period, Fosun Pharma's licensed product Daxxify® (DaxibotulinumtoxinA-lanm) became the first of its kind approved in China. The product received NMPA approval for the improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Accelerating Localization of Innovative Products in China to Achieve High-quality Development As a global innovation-driven pharmaceutical and healthcare company, Fosun Pharma actively introduces internationally advanced technologies and products to the Chinese market, benefiting patients and customers. During the reporting period, Fosun-Insightec, a joint venture established with Insightec in China, successfully achieved sales of magneticresonance image guided focused ultrasound brain therapy system ("MRgFUS brain therapy system") for brain treatment. Additionally, the headquarters and industrial base of Intuitive Fosun, an associated company, was officially inaugurated in the Zhangjiang International Medical Park in Shanghai. This facility integrates R&D, manufacturing, and training, further accelerating the localization of the da Vinci Robotic surgical systems in China. To further enhance its leading position in tumor immunotherapy, Fosun Pharma increased its stake in its cell therapy platform, Fosun Kairos, to 100% during the reporting period. The company will continue to collaborate with Kite Pharma to advance the development and commercialization of its licensed products, Axi-Cel (marketed as Yi Kai Da ) and Brexu-Cel (investigational project FKC889), in Chinese mainland, Hong Kong S.A.R and Macao S.A.R. Yi Kai Da became the first in China to introduce an innovative outcome-based payment model. As of the end of 2024, Yi Kai Da has benefited over 800 lymphoma patients, been included in more than 110 provincial and municipal government-backed insurance programs and over 80 commercial insurance plans, and has been registered in more than 180 treatment centers across 28 provinces and municipalities nationwide. While maintaining steady operations, Fosun Pharma remains committed to its corporate social responsibilities. In 2024, the company received multiple domestic and international accolades for its significant progress in ESG, including recognition as one of China's ESG Listed Company Pioneer 100, Deloitte's China Best Managed Companies, Charity Star, and Forbes 2024 China ESG 50 list. Additionally, Fosun Pharma's MSCI ESG rating remained at A. "Fosun Pharma will continue to adhere to innovation-driven and global development strategies, actively embrace AI, concentrate resources on core businesses, and persistently advance lean management and enhance operational efficiency." Wu Yifang, Chairman of Fosun Pharma said, "We aim to grow in tandem with China's biopharmaceutical industry and stride into a new phase of high-quality development. Upholding our mission to 'create better health for families worldwide', we will maintain a patient-centric approach, address unmet clinical needs, deepen innovation transformation and global expansion, and strive to become a global leader in healthcare innovation and integration." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy -Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide.
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.
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