DB-1311

Plus, news about Amicus Therapeutics, Fosun Pharma, Duality Biotherapeutics, BioNTech and C4 Therapeutics. 👁️ Abeona drops eye gene therapies, pivots to solid tumor T cell therapy: The biotech, which is known for marketing the rare skin disease gene therapy Zevaskyn, said it’s shifting development efforts to ABO-701, which is a PSMA-targeted T cell therapy for prostate cancer. At the same time, Abeona said it was dropping its line of AAV gene therapies for eye diseases. The platform underlying the prostate cancer therapy is meant to “overcome the limitations of CAR and TCR approaches,” according to Abeona, and was developed by University of Southern California physician-scientist Preet Chaudhary. — Lei Lei Wu 🥛 AstraZeneca’s rare disease drug passes Phase 3 test: Just over 31% of patients with hypoparathyroidism treated with eneboparatide achieved full normalization of blood calcium levels and independence from supplementation at 24 weeks, compared with 5.9% of placebo patients. The disease causes low calcium and high phosphorus levels in the blood, leading to a host of symptoms, including muscle aches and memory problems. The study also met all key secondary endpoints. The long-term extension period is ongoing. — Ayisha Sharma 👋 Amicus Therapeutics to lay off 11% of staff following buyout: A WARN notice with the New Jersey state government said that the company would lay off 58 employees between August and October of this year. As of the end of 2025, Amicus had 511 full-time employees, the biotech said in an SEC filing. Last December, BioMarin announced it would acquire Amicus for $4.8 billion. The transaction closed at the end of April. — Max Gelman 🧠 Fosun Pharma does another Alzheimer’s deal: The Shanghai company could take an Alzheimer’s drug that goes after the same mechanism as Viagra into the US and other markets. The drugmaker is teaming up with Korean biotech AriBio on a candidate, called AR1001, that will have Phase 3 data this year. Fosun could pay a $60 million option fee and up to $180 million in further upfront and regulatory milestones. AriBio has done previous deals on the drug for other regions . Fosun, which has global expansion ambitions , did a deal in December for a different Alzheimer’s drug that had previously been approved in China. — Kyle LaHucik 🤝 Update on Duality Biotherapeutics’ ADC pact with BioNTech: The Chinese biotech chose to split costs and profit/loss sharing in the US with BioNTech on their partnered B7-H3 antibody-drug conjugate. The company elected to opt in because its board believes the candidate, known as BNT324/DB-1311 , has “substantial commercial potential in the United States,” according to a Hong Kong Stock Exchange filing . The asset is part of a broader, up-to $1.5 billion deal outlined in 2023. — Kyle LaHucik ✂️ C4 Therapeutics shelves targeted lung cancer agent: The protein degradation biotech said it won’t move forward with an EGFR L858R degrader called CFT8919 outside of Greater China, where it has a partnership with Betta Pharmaceuticals. The company said that it made its decision “based on the evolving treatment landscape for EGFR mutated non-small-cell lung cancer, capital priorities, and available clinical data to date.” The agent is one of two clinical assets in C4T’s pipeline, following the company’s lead multiple myeloma asset cemsidomide. — Lei Lei Wu

5月12日，映恩生物发布公告称，公司已正式向BioNTech发出书面通知，决定行使双方于2023年围绕DB-1311/BNT324达成合作协议中的美国市场独家成本及利润/亏损分担选择权。 这意味着，映恩生物将进一步参与该产品未来在美国市场的开发与商业化收益分配。 根据合作协议，在行使该选择权后，映恩生物需承担对应的美国历史研发成本，随后双方将共同分担DB-1311/BNT324未来在美国市场的开发成本，以及商业化阶段的利润与亏损。 早在2023年4月，映恩生物将DB-1311与DB-1303授予BioNTech，首付款1.7亿美元，里程碑付款15亿美元。DB-1311/BNT324是映恩生物自主研发的一款靶向B7-H3的新一代ADC候选药物，以拓扑异构酶I抑制剂为载荷。B7-H3在多种实体瘤中高表达，同时在正常组织中的表达相对有限，因此被视为具有潜力的ADC开发方向之一。 现有临床数据表明，B7-H3 ADC 在广泛期小细胞肺癌（ES-SCLC）、鼻咽癌（NPC）、肉瘤、妇科肿瘤及脑转移等多个领域展现出显著的临床潜力，其应用边界仍在持续拓展。 目前，B7-H3赛道已聚集包括Merck & Co.、GSK、BMS等跨国药企，以及多家中国创新药公司。过去两年，围绕B7-H3 ADC的BD交易明显升温，也使其成为ADC领域竞争最激烈的热门方向之一。 全球B7-H3(CD276)靶向药物（截至2026年2月） 从临床进展来看，DB-1311/BNT324正在开展针对晚期或转移性实体瘤患者的1/2期临床试验。根据映恩生物披露的早期数据，该产品已在多种实体瘤中显示出一定抗肿瘤活性，同时整体安全性可控。此外，公司也正在推进其与PD-L1xVEGF-A双特异性免疫调节剂的联合治疗探索，希望进一步扩大产品在肺癌等适应症中的治疗潜力。 映恩生物表示，DB-1311/BNT324在多个肿瘤适应症中已展现出积极临床数据，美国市场具备较大商业化潜力，因此选择行使相关权益，以进一步把握产品未来全球化机会。 End 声明：本公众号所发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者，欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 请联系 商务合作 稿件征集 点击了解详情 往期回顾 2026全球肥胖药企十强出炉 一文读懂抗体：结构、分类与ADCC/ ADCP/ CDC机制