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拿下114亿美元BD大单 信达生物要打业绩翻身仗
Guo Ji Jin Rong Bao· 2025-10-22 14:49
四季度往往是创新药企BD的高峰期,刚刚,业内传来消息,信达生物与武田制药达成合作,总交易额 最高达114亿美元,刷新了中国创新药企BD史上的纪录。 10月22日,信达生物发布公告,公司与武田制药达成全球战略合作,旨在加速推进信达生物新一代免疫 肿瘤学(IO)及抗体偶联药物(ADC)疗法的全球开发与商业化。合作涵盖两款后期在研疗法:IBI363 (PD-1/IL-2α-bias)、IBI343(CLDN18.2 ADC),以及IBI3001(EGFR/B7H3 ADC)的选择权。 国际化进程提速 BD授权是医药行业中商务拓展(Business Development)的核心形式,特指企业通过战略性合作,将药 物或技术的开发、生产或销售权益授权给其他方。这种授权不涉及资产所有权转移,而是通过合同约定 权益分配,例如首付款、里程碑付款和销售分成。其核心目标是实现资源互补,降低研发风险,优化研 发管线,并加速药物商业化使其价值最大化,本质是知识产权的交易与合作,有利于创新药快速上市。 资料显示,总部位于苏州的信达生物成立于2011年,公司致力于研发、生产和销售肿瘤、自身免疫、代 谢、眼科等重大疾病领域的药物,公司已有 ...
德琪医药(06996) - 2025 H1 - 电话会议演示
2025-08-22 08:00
Antengene Pipeline Overview - Antengene is developing a diverse pipeline of Antibody Drug Conjugates (ADCs), Immuno-Oncology (IO) therapies, and treatments for Autoimmune Diseases [16, 102] - The company's "2+1" T Cell Engager (TCE) platform, AnTenGager, is designed with steric hindrance-masking technology to enhance therapeutic effect and safety [20, 109] ATG-022 (Claudin 18.2 ADC) - ATG-022, a Claudin 18.2 ADC, has shown efficacy across various CLDN18.2 expression levels in gastric cancer [20, 32, 48] - In CLDN18.2 moderate to high expressing GC (IHC 2+ > 20%) patients treated with ATG-022 at 2.4 mg/kg, the ORR was 40% (12/30), and the DCR was 90% (27/30) [20] - In CLDN18.2 low and ultra-low expressing GC (IHC 2+ ≤ 20%) patients, an efficacious dose range of 1.8-2.4 mg/kg of ATG-022 resulted in an ORR of 33.3% (6/18) and a DCR of 50% (9/18) [20] - The median progression-free survival (mPFS) in Gastric or GEJ Cancer with Moderate to High CLDN18 2 Expression (IHC 2+, >20%) Treated at 2 4 mg/kg is 6 97 months, with a 6-month progression-free survival (PFS6m) rate of 51 1% [53] - The company is planning to investigate ATG-022 in combination with Pembrolizumab and CAPOX in Advanced / Metastatic Claudin 18 2 Positive Gastric Cancer (1L) [64] - ATG-022 is estimated to have over US$5 billion in peak sales potential [68, 70] ATG-037 (Oral CD73 Small Molecule Inhibitor) - ATG-037, an oral CD73 small molecule inhibitor, has demonstrated efficacy in CPI-resistant Melanoma with an ORR of 36.4% (4/11) and a DCR of 100% (11/11) [20] - In CPI-resistant Non-small Cell Lung Cancer, ATG-037 showed an ORR of 21.4% (3/14) and a DCR of 71.4% (10/14) [20] - The Immuno-oncology (IO) market is estimated to be $140+ billion in 2028 [78] AnTenGager TCE Platform - ATG-201, a CD19 x CD3 TCE, is IND-enabling for B Cell Driven Autoimmune Diseases, demonstrating deep B cell depletion with low CRS [16, 20, 119] - ATG-106 (CDH6 x CD3) is a First-in-Class CDH6 TCE for Ovarian Cancer and Kidney Cancer [17, 103, 132]