Core Viewpoint - Innovent Biologics (01801.HK) announced that its drug, Dabrusin® (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer when combined with Sintilimab [1] Group 1 - Dabrusin® is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - The approval of the anti-CTLA-4 monoclonal antibody Daberxin® (Ipilimumab N01 injection) by the National Medical Products Administration (NMPA) marks a significant breakthrough in the treatment of resectable IIB-III stage microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer patients in China, establishing it as the first domestically developed anti-CTLA-4 inhibitor approved for this indication [1][2]. Group 1 - Daberxin® is now the first domestically approved anti-CTLA-4 inhibitor in China, representing a global first for a "dual immunotherapy" neoadjuvant treatment regimen for colorectal cancer [1][2]. - Approximately 15% of resectable colorectal cancer patients are classified as MSI-H/dMMR, who have historically lacked effective pre-surgical treatment options, often relying on "surgery + chemotherapy" with high recurrence risks [1]. - The NeoShot-III study demonstrated that 82% of the first 50 patients receiving the "dual immunotherapy" neoadjuvant treatment achieved pathological complete response (pCR), with a 100% surgical resection rate and no additional safety risks compared to direct surgery [2]. Group 2 - As of 2025, the company has successfully launched seven innovative drugs, with significant products or key data emerging in oncology, metabolism, autoimmune diseases, and ophthalmology [3]. - The company is transitioning from a single-focus on oncology to a dual-driven approach encompassing both oncology and chronic diseases, aiming to establish a comprehensive commercialization platform in the chronic disease sector [3]. - The company targets to exceed 20 billion yuan in product revenue by 2027, supported by the continued growth of chronic disease products and stable contributions from core oncology products [3].

12月25日，信达生物（香港联交所：01801.HK）自主研发的抗CTLA-4单抗达伯欣®（伊匹木单抗N01 注射液）获得国家药品监督管理局（NMPA）批准，联合PD-1抑制剂达伯舒®（信迪利单抗注射液）用 于可手术切除的IIB-Ⅲ期微卫星高度不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌患者的新 辅助治疗。 这一获批使达伯欣®成为中国首个国产获批上市的抗CTLA-4抑制剂，也意味着全球首个用于该适应症 的"双免疫"新辅助治疗方案率先在中国落地，为结肠癌术前治疗带来实质性突破。 结肠癌是常见的消化道恶性肿瘤，其中约15%的可手术患者属于MSI-H/dMMR类型 。由于对传统化疗 不敏感，这类患者长期缺乏有效的手术前治疗方式，大多数患者仍只能依赖"手术+化疗"，但术后复发 风险依然存在，且化疗带来的副作用可能严重影响生活质量。 随着免疫治疗在晚期MSI-H/dMMR人群中展现强效，临床对"能否在手术前使用更有效的治疗方式提升 肿瘤清除率"愈发关注，但有效的新辅助方案一直缺位。伊匹木单抗N01与信迪利单抗的"双免"组合在 此背景下带来了突破性证据。 该项研究的主要研究者、中国工程院院士、中山大学肿瘤防治 ...

12月25，信达生物制药集团宣布，达伯欣®（伊匹木单抗N01注射液，细胞毒性T淋巴细胞相关蛋白4 （CTLA-4）单抗，研发代号：IBI310）获得中国国家药品监督管理局（NMPA）批准上市，联合信迪 利单抗用于可手术切除的IIB-III期微卫星高度不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌 患者的新辅助治疗。 ...