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——The World's First Precisely Regulated Injectable CaHA Filler, Accelerating Compliance in the Medical Aesthetics Industry in China. SHANGHAI, March 21, 2025 /PRNewswire/ -- Shanghai Moyom Biotechnology's high-profile brand, Aphranel® MagiCCrystal CaHA Filler, has officially obtained Class III Medical Device Certificate from the China National Medical Products Administration (NMPA) (Registration Certificate Number.: 20253130390). This makes it the first calcium hydroxylapatite microsphere (CaHA) injectable product approved in China for facial soft tissue augmentation. This certificate not only signifies the elevation of regulatory standards in China's medical aesthetics industry but also provides a safer and more efficient bio-stimulating medical aesthetics solution for the global market. Technological Breakthrough: Defining New Global Standards for Bio-stimulating Medical Aesthetics Calcium hydroxylapatite (CaHA) microspheres have become a core material in the global bio-stimulating injection field due to their excellent biocompatibility and biodegradability, with a market adoption rate 71% higher than poly-L-lactic acid (PLLA). Leveraging proprietary technology, Moyom has precisely controlled CaHA microsphere size (30-35μm), through-hole structure, and degradation rate, successfully developing the Aphranel® MagiCCrystal CaHA Filler. Its raspberry-like through-hole design increases porosity by 40%, with the number of microspheres per unit volume exceeding 6 times that of competing product. The viscoelastic modulus (G' value) reaches 5500Pa, enabling long-lasting 3D supporting effect. The product employs a pre-mixing technology combining CaHA and CMC (carboxymethyl cellulose), ensuring uniform particle suspension and a smoother injection push force. Validated by 31 biochemical tests, its inflammation rate is 30% lower than the state of art, and it is fully biodegradable. Its safety has been certified by Notified bodies in the EU (MD, MDSAP), Brazil(ANVISA), Russia(RZN), Saudi Arabia(SFDA), Mexico (COFEPRIS), and other countries. Global Expansion: Innovation-Academia-Research Ecosystem As a National high-tech enterprise, Shanghai Moyom Biotechnology has built an innovation network through a "Chinese R&D + Local transformation" model: Research Collaboration: Partnering with institutions such as Nanjing Tech University and the Chinese Academy of Sciences to advance biomaterial technology. Clinical Validation: Collaborating with authoritative institutions like the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences and Shanghai Ninth People's Hospital to complete multicenter clinical trials. International Expansion: Establishing joint laboratories with medical aesthetics experts from Germany and Brazil to promote localized adaptation of technology. The company's core team brings together PhDs from top universities such as Fudan University and Shanghai Jiao Tong University, as well as technical experts from listed healthcare companies. Additionally, Moyom has engaged in cross-disciplinary collaboration with the Shanghai Theatre Academy, integrating medical and aesthetic design principles. Capital Empowerment, Reshaping Industry Value In 2024, Moyom Biotechnology completed nearly 100 million RMB of Plan B+ financing, led by Boyuan Capital and SAIC Hengxu Capital, with a cumulative financing of over 500 million RMB. The funds will be used for globalization capacity expansion and second-generation absorbable implant research and development. "The approval of the Aphranel® MagiCCrystal CaHA Filler is an important node in the industry's compliance," said the CEO of Moyom Biotechnology, "We are committed to providing safer and more accessible products for the global medical aesthetics market through technological innovation, and promoting the sustainable development of the industry."
BEIJING, March 21, 2025 /PRNewswire/ -- Syneron Bio, a cutting-edge oral macrocyclic peptide drug biotech company, announced today a strategic collaboration with the global biopharmaceutical leader AstraZeneca to develop potential first-in-class macrocyclic peptides for the treatment of chronic diseases. Under this collaboration, AstraZeneca will gain access to Syneron Bio's innovative Synova™ platform, an intelligent and high-throughput macrocyclic peptide drug research and development platform, designed to support the advancements of research programmes exploring possible future treatments of chronic diseases, including rare, autoimmune, and metabolic disease. Under the terms of the agreements, AstraZeneca will provide upfront payments and potential near-term milestone payments totaling $75 million and up to $3.4 billion in additional development and commercial milestones. In addition, tiered royalties will be paid based on global sales. AstraZeneca will also make an equity investment . As a result of this collaboration, Syneron Bio plans to expand its Beijing R&D center. Dr. Frank Zhang, Founder and CEO of Syneron Bio, commented, "We are honored to partner with AstraZeneca. Interest in our Synova™ platform is incredibly inspiring and driven by the promising research and results we have already delivered. In the face of growing challenges posed by chronic diseases such as autoimmune and metabolic disorders, this collaboration underscores our commitment to advancing drug development. About Syneron Bio: Syneron Bio is a biotech company dedicated to the development of next-generation macrocyclic peptide therapeutics, employing its proprietary Synova™ platform. The company has built a robust pipeline targeting oncology and chronic diseases. With a team experienced in drug development and data science, Syneron Bio has completed multiple rounds of equity financing in less than three years, backed by multiple leading venture capital funds.
SHANGHAI and HONG KONG, March 21, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) today announced its full-year results for the period ending December 31, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "To Antengene, 2024 was indeed an extraordinary year in which we achieved remarkable progress on multiple fronts, including clinical development, R&D and commercialization. ATG-022, our Claudin 18.2 antibody-drug conjugate that is being evaluated in a Phase II study in Australia and China, has shown highly differentiated clinical potential, demonstrating efficacy not only in gastric cancer patients with mid to high Claudin 18.2 expressions, but also unprecedented clinical benefit for patients with low or ultra-low expressions. Furthermore, AnTenGagerTM TCE 2.0, Antengene's proprietary platform incorporating steric hindrance-masking technology, has shown impressive capabilities, with its preclinical data demonstrating a significantly more favorable safety profile than those of the first-generation TCE platforms, and potential clinical efficacy covering solid tumors, hematologic malignancies and autoimmune diseases. We will seek various forms of collaboration with global partners around this technology platform in order to fully unlock its potential value. ATG-201, a CD19 x CD3 TCE 2.0 developed on the AnTenGageTM TCE 2.0, is poised to enter clinical development in the second half of 2025. In addition to the rapid progress in R&D and clinical development, we also achieved impressive results in commercialization. Our first approved product, XPOVIO®, has clearly picked up momentum in its global expansion while having its second indication approved and included in the NRDL in China. Also during the reporting period, XPOVIO® was included for reimbursement in South Korea and Taiwan China, and approved for commercialization in Malaysia, Thailand, and Indonesia. To date, XPOVIO® has been approved in 10 APAC markets and included for reimbursement coverage in 5 of those markets. Currently, the company has a cash reserve of RMB 900 million which is sufficient to fund its continued operations over the next three years even without future revenue income. We look forward to updating you all on our progress in 2025, with the next one being the latest results on the AnTenGageTM TCE 2.0, scheduled for release at this year's AACR Annual Meeting." 1. Claudin 18.2 ADC Demonstrates Significant Clinical Value, with Multiple Programs Advancing Steadily at the Clinical Stage ATG-022（Claudin 18.2 Antibody-Drug Conjugate, ADC） Unique Therapeutic Potential: ATG-022 is a highly differentiated ADC demonstrated efficacy across the broadest range of CLDN18.2 expression levels. Clinical data show that ATG-022 not only effectively targets gastric cancer patients with high CLDN18.2 expression but is also effective in tumors with low and ultra-low CLDN18.2 expression. Additionally, ATG-022 has shown better safety profile without accumulative systemic toxicities, and much fewer dose-limiting toxicities and lower high grade adverse effects compared to other CLDN 18.2 ADCs in similar clinical development stages. It also has received two Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric and pancreatic cancer. Ongoing CLINCH study: As of November 22, 2024, among 21 gastric cancer patients in the dose expansion phase with CLDN18.2 expression at IHC 2+ ≥ 20% achieved an Objective Response Rate (ORR) of 42.9% and a Disease Control Rate (DCR) of 95.2% (9 patients had Partial Responses [PR], 8 of which were confirmed; 11 patients had Stable Disease [SD]). Additionally, 10 patients with CLDN18.2 expression at IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg had an ORR of 30.0% (1 patient achieved a Complete Response [CR], 2 achieved PR, and all confirmed CR/PR cases had CLDN18.2 expression IHC 2+ < 5%), with a DCR of 50.0%. The patient who achieved a CR has demonstrated sustained remission and has been in the study for over 14 months as of the data cut-off date. The Phase II CLINCH study is progressing smoothly in China and Australia. Other Clinical Stage Programs ATG-037 (CD73 Small Molecule Inhibitor): ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with anti-PD-1 resistant melanoma and non-small cell lung cancer (NSCLC). At the 2024 European Society of Medical Oncology (ESMO) Congress, clinical data from the ongoing Phase I STAMINA dose-escalation study were presented in a Mini Oral session. As of the latest data cut-off date on November 27, 2024, among the 26 evaluable patients with prior anti-PD-1 resistance who received ATG-037 in combination with pembrolizumab, 9 had NSCLC and 11 had melanoma. Among these patients, the ORR is 35% and DCR is 85%. These data indicate that ATG-037 has the potential to reverse anti-PD-1 resistance during the dose-escalation phase. Currently, the Phase II STAMINA dose optimization and expansion study is progressing smoothly in China and Australia. ATG-031 (Anti-CD24 Monoclonal Antibody): ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. The Phase I PERFORM study is progressing smoothly in the U.S. 2. The Exciting Proprietary AnTenGagerTM TCE 2.0 with Steric Hindrance-masking Technology Next-Generation TCE Platform: The AnTenGagerTM TCE 2.0 is Antengene's proprietary "2+1" TCE platform which features a steric hindrance-masking technology designed to enable disease-associated antigen (DAA)-dependent T-cell activation. This approach is intended to achieve potent therapeutic activity while reducing the risk of cytokine release syndrome (CRS). Compared to first-generation TCE platforms, AnTenGagerTM TCE 2.0 offers better safety and has broader applicability in different indications such as in solid tumors, hematological malignancies, and autoimmune diseases. Additionally, AnTenGagerTM TCE 2.0 has a longer half-life, which allows for reduced dosing frequency and improved clinical convenience. The company will continue to advance the development of AnTenGagerTM TCEs. Global Collaborations: Antengene will seek a range of collaborations with its global partners for the AnTenGageTM TCE 2.0, through platform access, co-development, and out-licensing, in order to enable the accelerated development of an ecosystem around TCE therapeutics and maximize the value of the technology platform. ATG-201 (CD19 x CD3 TCE 2.0): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed using the AnTenGagerTM TCE 2.0 for the treatment of B cell related autoimmune diseases. In preclinical studies, ATG-201 demonstrated superior B-cell depletion compared to benchmark molecules, along with reduced cytokine release. The company expects ATG-201 to enter clinical development in the second half of 2025. Antengene will continue to advance other preclinical programs, including ATG-042 (a selective PRMT5 inhibiting targeting MTAP-null tumors), ATG-106 (CDH6 x CD3 TCE 2.0) for ovarian and renal cancer, and ATG-110 (LY6G6D x CD3 TCE 2.0) for microsatellite stable (MSS) colorectal cancer. 3. Accelerating Global Expansion: Covering 10 APAC Markets Mainland of China: In July 2024, XPOVIO® received approval for a second indication in Mainland China, providing a new treatment option for Chinese DLBCL patients. In November 2024, this indication was included in the National Reimbursement Drug List (NRDL). As of now, both approved indications of XPOVIO® in China are covered under national insurance, further expanding patient access. South Korea: In June 2024, XPOVIO® received national reimbursement approval in Korea, effective from July 1, 2024. In October 2024, XPOVIO® was approved for an additional third indication in Korea. The company is actively working to expand reimbursement coverage for more indications in Korea. Taiwan Market: In February 2025, XPOVIO® received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore. ASEAN Markets: Since August 2024, XPOVIO® has been successively approved in Malaysia, Thailand, and Indonesia, marking significant progress in Antengene's commercialization strategy across the APAC region. XPOVIO® is now approved in 10 countries and regions across APAC for multiple indications. 4. Strong Cash Reserves to Support Continuous Growth As of December 31, 2024, the company held RMB 900 million in cash and bank balances, which is sufficient to fund the company's continuous growth and operations over the next three years even without additional financing. To learn more about the annual financial results of 2024, please see the full announcement on the "Investor Relations" section of the website. 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". Since 2017, 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 QianE-mail: Peter.Qian@antengene.com Mobile: +86 13062747000
SHANGHAI, CAMBRIDGE, Mass. and ROTTERDAM, Netherlands, March 21, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, today announced a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed's proprietary Harbour Mice® fully human antibody technology platform in multiple therapeutic areas and a $105 million equity investment by AstraZeneca in Harbour BioMed. Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover next generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development. The initial phase of the strategic collaboration will focus on ongoing research programs, with the potential for additional programs. In return, Harbour BioMed will receive an upfront payment, near-term milestone payments, and option exercise fees for additional programs, totaling $175 million, as well as up to $4.4 billion in additional development and commercial milestone payments, along with tiered royalties on future net sales. Additionally, the parties have the option to include additional programs into the collaboration over the next five years, with the option to extend the terms of the agreement for an additional five years upon mutual agreement. Furthermore, AstraZeneca will acquire 9.15% newly issued shares of Harbour BioMed. To support the collaboration programs under this agreement and other joint initiatives between the two parties, Harbour BioMed will establish an innovation center in Beijing, China to be co-located with AstraZeneca. Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "This strategic collaboration with AstraZeneca marks a significant step in advancing next-generation antibody therapeutics, reinforcing Harbour BioMed's position as a leader in multi-specific biologics innovation. By leveraging our cutting-edge discovery capabilities and AstraZeneca's expertise in drug development, we aim to accelerate the creation of transformative therapies for patients with high unmet medical needs." About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platform Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to www.harbourbiomed.com.
Strategic Acquisition of Intellectual Property of BRII-179, a Wholly Owned Phase 2b Asset Capable of Combining with Multiple HBV Treatment Modalities for Cure Data from Multiple Ongoing Late-Stage Studies Reinforce Brii Bio's HBV Functional Cure Strategy of Optimized Combination Regimens to Target Patient Populations 4 Abstracts Including 2 Oral Presentations with Data from the Ongoing Phase 2 ENSURE Study at the Upcoming APASL (March 26-30) Strong Cash Reserves of US$335.7 Million to Propel Operations into 2028 Actively Seeking Partnership Opportunities for Non-HBV Programs Conference Call (English Session) Scheduled for March 31 at 8:30 PM HKT / 8:30 AM ET DURHAM, N.C. and BEIJING, China, March 21, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical needs provided a corporate update today and reported its financial results for the year ended December 31, 2024. In 2024, Brii Bio advanced its core hepatitis B virus (HBV) functional cure program, gaining valuable data from ongoing Phase 2 trials that support its goal of achieving higher functional cure rates for patients through combined immunomodulation and surface antigen reduction approaches. These data support BRII-179 (a recombinant protein-based HBV immunotherapeutic) as a key differentiator through identifying patients who are potentially more susceptible to curative therapies. Two Phase 2b studies, ENRICH and ENHANCE, are fully enrolled to confirm these important findings. End-of-treatment (EOT) data from its ENSURE study suggests a direct role of elebsiran (an HBV-targeting siRNA) in achieving a higher HBV functional cure rate. Elebsiran is currently being evaluated in multiple ongoing trials with Brii Bio's other assets, including ongoing trials of tobevibart (a broadly neutralizing monoclonal antibody targeting HBV) run by Vir Biotechnology, Inc. ("Vir Biotechnology," Nasdaq: VIR). Upcoming 2025 data readouts from these studies will guide Brii Bio's late-stage development and registration strategy. Brii Bio remains well-funded with a cash position of US$335.7 million, sufficient to support the Company through late-stage development plans for HBV functional cure. "The critical milestones we achieved in 2024 have strengthened our HBV portfolio of multiple mechanisms of action at both the clinical and strategic level," stated Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Data from multiple ongoing combination studies with our highly differentiated HBV assets continue to show that our multi-modal approach has the potential to produce higher functional cure rates across broader HBV patient groups. With the strategic acquisition of BRII-179 and data from three ongoing Phase 2b studies throughout this year and next, we are creating multiple curative treatment options for patients with chronic HBV infection." Clinical Development Update Brii Bio is actively advancing its innovative product pipeline, with a primary focus on the late-stage clinical development of its flagship HBV program. HBV Program The Company is progressing multiple ongoing combination studies with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA; BRII-179, a recombinant protein-based HBV immunotherapeutic. The Company's partner, Vir Biotechnology, is also progressing multiple combination studies with elebsiran and tobevibart, a broadly neutralizing monoclonal antibody targeting HBV surface antigen. By addressing HBV from these three distinct therapeutic perspectives in varying combinations with each other, Brii Bio aims to determine the best curative regimens to address different population subsets and the most efficient regulatory path to approval. Upcoming pivotal data sets from the Company's ongoing ENRICH (BRII-179 in priming HBV-specific immunity and enriching patients with competent immunity) and ENSURE (elebsiran in combination with PEG-IFNα versus PEG-IFNα alone) studies are expected throughout 2025-2026 and will further inform late-stage studies as Brii Bio advances toward determining HBV functional cure. Brii Bio completed enrollment in its ENHANCE study in January 2025. The ENHANCE study is a Phase 2b, randomized, double-blind study evaluating the clinical efficacy and safety of the combination therapy of BRII-179, elebsiran, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy. Brii Bio presented 48-week EOT data from its Phase 2 ENSURE study at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in a late-breaking oral presentation in November 2024. Data showed patients treated with elebsiran in combination with PEG-IFNα achieved a higher rate of HBV surface antigen loss (HBsAg) than patients treated with PEG-IFNα alone. The ENSURE study data marks the industry's first evidence delineating the contribution of siRNA (elebsiran) toward functional cure on top of PEG-IFNα therapy through head-to-head comparison with PEG-IFNα alone, highlighting elebsiran's potential to make a substantial impact on producing higher HBV functional cure rates. Brii Bio plans to present additional key data readouts in the first half of 2025. The ENSURE study is also investigating patients with prior experience of receiving BRII-179. Based on early data from Cohort 4 of the ENSURE study (data to be released at APASL 2025), the ENRICH study was fully enrolled in November 2024, evaluating the role of BRII-179 in priming HBV-specific immunity as part of a curative regimen and as a tool to identify immuno-responsive patients with a higher probability of achieving functional cure. Brii Bio's development partner, Vir Biotechnology, presented data from its Phase 2 MARCH and SOLSTICE studies at AASLD's The Liver Meeting in November 2024. Vir Biotechnology recently commenced a Phase 3 registrational clinical program (ECLIPSE) to evaluate the tobevibart and elebsiran combination in people living with chronic hepatitis delta (CHD). Vir Biotechnology was granted Fast Track designation for tobevibart and elebsiran for the treatment of CHD in June 2024 by the U.S. Food and Drug Administration (FDA), followed by Orphan designation by the European Medicines Agency (EMA) in November 2024, and FDA Breakthrough Therapy Designation and EMA Prime Designation in December 2024. The CDE granted Breakthrough Therapy Designations (BTD) for tobevibart and elebsiran in May 2024. Additional Clinical Programs Brii Bio is actively seeking external partnerships for its therapeutic candidates for HIV, MDR/XDR and central nervous system diseases. In October 2024, Brii Bio received IND approval from CDE of NMPA for a Phase 1 PK bridging study in China with BRII-693, a novel polymyxin for the treatment of serious gram-negative infections. Previous phase 1 data has been published on Antimicrobial Agents and Chemotherapy in December 2024, supporting future global Phase 3 registrational trial in patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Brii Bio holds exclusive global rights to develop and commercialize BRII-693. Full Year 2024 Corporate Highlights and Recent Update In December 2024, Brii Bio announced the approval of a HK$60 million share-buyback program, or 10% of its total outstanding shares, underscoring the Company's confidence in its prospects. As of March 21, 2025, the Company had repurchased approximately 4,433,000 shares on the Hong Kong Stock Exchange for a consideration of approximately HK$5.3 million. In December 2024, Brii Bio signed an asset purchase agreement with VBI Vaccines, Inc. ("VBI") and its associated subsidiaries to acquire full intellectual property rights and other assets relating to BRII-179 for a total consideration of $18 million. The agreement eliminates future payments to VBI related to BRII-179 and PreHevbriTM and dissolves the prior agreement announced on February 14, 2024. The purchase brings Brii Bio additional commercial upside while ensuring the uninterrupted clinical supply of BRII-179 as the Company continues to develop this asset with ongoing studies that support BRII-179's potential to increase HBV patients' response to curative treatments. Full Year 2024 Financial Results Our bank deposits and cash and cash equivalents were RMB2,413.4 million as of December 31, 2024, representing a decrease of 248 million or 9.3% compared with RMB2,661.4 million as of December 31, 2023. The decrease was primarily due to payout of daily operations and research and development activities. Other income was RMB141.4 million for the year ended December 31, 2024, representing a decrease of RMB22.3 million or 13.6%, compared with RMB163.7 million for the year ended December 31, 2023. This was mainly due to the decrease in bank interest income of RMB20.8 million attributable to the declining interest rates on USD and HKD time deposits and the decrease in income recognized from PRC government grants. Research and development expenses were RMB249.8 million for the year ended December 31, 2024, representing a decrease of RMB152.9 million or 38.0%, compared with RMB402.7 million for the year ended December 31, 2023. The decrease was primarily attributable to the decrease in third-party contracting cost of RMB79.3 million and the decrease in employee cost of RMB67.7 million, which were primarily due to pipeline prioritization and organizational optimization during the year. Administrative expenses were RMB153.2 million for the year ended December 31, 2024, representing a decrease of RMB43.3 million or 22.0%, compared with RMB196.5 million for the year ended December 31, 2023. The decrease was primarily attributable to the decrease in employee cost of RMB39.7 million, which was primarily attributable to pipeline prioritization and organizational optimization during the year. Loss for the year was RMB512.4 million for the year ended December 31, 2024, representing an increase of RMB328.0 million or 177.9%, compared with RMB184.4 million for the year ended December 31, 2023. The increase in loss was primarily attributable to investment-related losses of RMB126.1 million and impairment losses of RMB90.3 million, partially offset by the decrease in research and development expenses and administrative expenses. In contrast to the prior year, which benefited from a significant gain on the one-time sale of assets of RMB131.8 million and the increase in the share price of an equity investment of RMB129.2 million, the current year was impacted by a decline in the fair value of the same equity investment. Conference Call Information A live conference call (English session) will be hosted on March 31, 2025 at 08:30 AM U.S. Eastern Time (8:30 PM Hong Kong Time) when the management team will provide an annual update including data to be presented at the APASL conference on March 26-30. All participants are required to register in advance of the call. For the registration link, please click here. All participants shall use the link provided above to complete the online registration process prior to the conference call. Upon registering, each participant will receive an email with important details for this call, including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com under the Investor Relations section. *** This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information. About Brii Bio Brii Biosciences Limited ("Brii Bio," stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com. Forward-Looking Statement The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
HONG KONG, March 21, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) presented promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab (AK104), in combination with concurrent chemoradiotherapy (CCRT) for the treatment of locally advanced cervical cancer. Currently, CCRT is the standard of care for locally advanced cervical cancer, but approximately 30%-40% of patients experience relapse or disease progression within five years. Cadonilimab, with its unique dual-target mechanism, is designed to simultaneously inhibit the PD-1 and CTLA-4 immune checkpoint pathways. It has received approval from the National Medical Products Administration (NMPA) in China for use in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. The Phase III COMPASSION-16 study further confirmed that cadonilimab, when combined with platinum-based chemotherapy (with or without bevacizumab), significantly improves progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. Based on these compelling results, the supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment for persistent, recurrent, or metastatic cervical cancer is currently under regulatory review. At this year's SGO, data from the COMPASSION-18 study highlighted the exceptional efficacy seen in patients receiving cadonilimab in combination with CCRT during the safety run-in phase. The results demonstrate the considerable therapeutic potential of cadonilimab combined with CCRT for locally advanced cervical cancer. The study included a more challenging patient cohort, with a notably higher proportion of patients having PD-L1 CPS <1 (38.2%) and an ECOG performance status of 1 (52.9%) compared to other similar studies. Overall Response Rate (ORR): The evaluable patients achieved a remarkable ORR of 100%, with a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%, which significantly outperformed data from other comparable studies. The median duration of response (DoR) has yet to be reached. Progression-Free Survival (PFS): While the median PFS has not been reached, the 12-month PFS rate was 74.9%. Subgroup Analysis: Patients with PD-L1 CPS ≥1, ECOG 0, and those not infected with COVID-19 derived even greater benefit from the treatment, with 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively. Safety Profile: Cadonilimab combined with CCRT exhibited a favorable safety profile, demonstrating good tolerability and manageable adverse events. Notably, there were no treatment-related deaths (TRAE) and no new safety concerns were identified. Cadonilimab is making significant progress in treating both recurrent/metastatic and locally advanced cervical cancer, establishing a comprehensive therapeutic approach. The positive results from the COMPASSION-18 study reinforce its potential in a broader patient population. As clinical development continues, cadonilimab is set to redefine cervical cancer treatment, offering long-term survival benefits to more patients.
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Medical/Pharmaceuticals
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