科伦博泰(06990.HK)今天公告，核心产品芦康沙妥珠单抗(SAC-TMT)联合PD-L1单抗塔戈利单抗作为一 线疗法，治疗无驱动基因突变的局部晚期或转移性非鳞状非小细胞肺癌，获中国国家药品监督管理局 (NMPA)药品审评中心(CDE)授予突破性疗法认定。据介绍，突破性疗法认定授予那些证明较现有治疗 手段具有明显临床优势的治疗选项，旨在加快研究、开发及推广创新治疗方案，以应对临床急需的医疗 需求。 这是芦康沙妥珠单抗获国家药品监督管理局授予的第五项突破性疗法认定。作为科伦博泰的核心产品， 芦康沙妥珠单抗是一款拥有自主知识产权的新型抗体偶联药物(ADC)，主要针对非小细胞肺癌、乳腺 癌、胃癌、妇科肿瘤等晚期实体瘤。 截至目前，科伦博泰已在中国开展8项注册性临床研究。默沙东已启动14项芦康沙妥珠单抗作为单药疗 法或联合帕博利珠单抗2或其他药物用于多种类型癌症的全球性3期临床研究，这些研究由默沙东申办并 主导。2022年5月，科伦博泰授予默沙东在大中华区以外的所有地区开发、使用、制造及商业化芦康沙 妥珠单抗的独家权利。 6月5日，科伦博泰公告，与两家配售代理签订配售协议，计划配售591.8万股H股股份，每股配售价 ...

6月10日，中国国家药监局药品审评中心(CDE)官网公示，第一三共(DSNKY.US)申报的注射用德曲妥珠 单抗(T-DXd,DS-8201a)拟纳入优先审评，拟定适应症为：单药适用于治疗既往接受过一种治疗方案的局 部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者。 基于DESTINY-Gastric01、DESTINY-Gastric02等多项2期研究结果，德曲妥珠单抗作为HER2阳性转移性 胃癌的二线和三线治疗策略已得到证实。因此，德曲妥珠单抗在多个国家或地区获批用于治疗既往接受 过曲妥珠单抗治疗的HER2阳性转移性胃癌或胃食管结合部腺癌。 根据第一三共公开资料介绍，DESTINY-Gastric04是德曲妥珠单抗治疗HER2阳性晚期胃癌的首个3期研 究。该研究总体阳性结果表明，与雷莫西尤单抗+紫杉醇相比，德曲妥珠单抗为HER2阳性(IHC3+或 IHC2+/ISH+)转移性胃或胃食管结合部(GEJ)腺癌患者带来具有显著统计学差异和临床意义的总生存期 (OS)改善。 今年6月，《新英格兰医学杂志》(NEJM)发表了DESTINY-Gastric04研究结果，显示在HER2阳性转移性 胃癌或胃食管结合 ...

Group 1 - The core point of the article is that CSP301, a novel EGFR antibody-drug conjugate developed by the company, has received its third Fast Track designation from the FDA for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients without EGFR mutations or other driver gene alterations who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - CPO301 has previously received two Fast Track designations from the FDA, the first in June 2023 for treating EGFR-mutant metastatic NSCLC patients who have relapsed or are refractory after EGFR-targeted therapy, and the second in September 2024 for treating recurrent or metastatic squamous NSCLC patients with EGFR overexpression who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - Lung cancer is the most prevalent and deadliest cancer globally, with approximately 2.5 million new cases and 1.8 million deaths annually, driven by activated EGFR gene mutations and overexpression of the EGFR protein [2] Group 2 - CPO301's Fast Track designations are based on encouraging clinical efficacy data, indicating its potential for greater activity compared to existing NSCLC and other cancer treatment options [2] - CPO301 is a humanized monoclonal antibody optimized from cetuximab and conjugated with topoisomerase I inhibitors, currently undergoing clinical studies in both China and the United States [2] - The Fast Track designation from the FDA will facilitate the development and registration process of CPO301 in the U.S. and globally [2]

Core Viewpoint - The company announced promising preclinical results for its novel FGFR2b-targeted antibody-drug conjugate (ADC) TST105, which demonstrates enhanced anti-tumor activity compared to existing ADCs in models of gastric and colorectal cancers [1][2]. Group 1: Clinical Research Findings - TST105 utilizes a site-specific conjugation technology and a novel topoisomerase I inhibitor as its payload, showing significantly improved anti-tumor efficacy in preclinical gastric and colorectal cancer models compared to ADCs using MMAE as a payload [1]. - In vitro studies indicate that TST105 exhibits specific cytotoxic effects on gastric and colorectal cancer cells, with an efficacy range of 0.3 nM to 0.4 nM, and demonstrates a stronger bystander effect compared to MMAE-based ADCs [2]. - In vivo pharmacological studies reveal that TST105 achieves a tumor growth inhibition (TGI) rate of 91.25% at a dose of 3 mg/kg in gastric cancer models, compared to 48.32% for Bema-MMAE, with an overall response rate (ORR) of 70% for TST105 versus 0% for Bema-MMAE [2]. Group 2: Industry Context and Future Prospects - The company expressed excitement about the transformative potential of TST105 in treating FGFR2b-overexpressing tumors, emphasizing its commitment to advancing this promising candidate into clinical development [3]. - The AACR 2025 conference, scheduled for April 25-30, 2025, in Chicago, serves as a significant platform for sharing advancements in cancer research, bringing together scientists, clinicians, and advocates to discuss the latest breakthroughs in oncology [3].

实际上，映恩生物在IPO前融资阶段便已获众多投资人青睐。映恩生物上市前引入了多达15位基石投资 者，合共认购6500万美元(约合5.05亿港元)，投资人大牌云集，不仅有BioNTech SE和礼来等业界明星企 业重磅加盟，还引入了世界顶级长线基金富国基金以及易方达基金、汇添富基金等国内头部基金共同参 与，如此多顶级投资人鼎力相助，阵容之强，可以说是近年之最。 IPO行至招股结束阶段，也就意味着映恩生物上市在即。在港股市场投资一家创新药公司，投资者需要 从公司潜在增长空间和创新研发实力两大关键要素出发，把握公司创新产品管线背后的超预期商业价 值，而这同样也是未来投资者长期配置映恩生物的核心逻辑。 作为全球抗体偶联药物(ADC)领域的关键领跑者，映恩生物主要致力于为癌症和自身免疫性疾病等患者 研发ADC创新药物。 坐拥自2022年以来18A生物科技板块内最大融资规模，暂居2025年港股IPO首日涨幅榜榜首......映恩生 物-B(09606)凭借上述成绩，完成了从"国内ADC黑马"向"港股18A明星标的"的华丽转身。 据智通财经APP了解，此次映恩生物IPO发行价为94.60港元/股，募资总额约2.11亿美元( ...

智通财经APP讯，映恩生物-B(09606)于2025年4月7日至4月10日招股，公司拟全球发售1507.16万股股 份，其中，香港发售占10%，国际发售占90%，另有超额配股权15%。每股发售价94.6-103.2港元，每手 100股，预期股份将于2025年4月15日(星期二)开始在联交所买卖。 我们于2019年注册成立，是全球抗体偶联药物(ADC)领域的关键领跑者，致力于为癌症和自身免疫性疾 病等患者研发ADC创新药物。我们拥有自主研发的两款核心产品，即DB-1303/BNT323(一款靶向癌症 (包括子宫内膜癌(EC)及乳腺癌(BC))的HER2 ADC候选药物)及DB-1311/BNT324(一款靶向癌症(包括小细 胞肺癌(SCLC)、去势抵抗性前列腺癌(CRPC)、食管鳞状细胞癌(ESCC)及头颈部鳞状细胞癌(HNSCC))的 B7-H3 ADC候选药物)。 除核心产品外，我们还自主研发了：五款其他临床阶段ADC(即DB-1310、DB-1305/BNT325、DB- 1312/BGC9074、DB-1419及DB-2304)，在广泛适应症中具有潜力，根据Frost & Sullivan，就总体或主 ...