信达生物(01801)发布公告，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 克隆抗体(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)或错配修復缺陷型(dMMR)结肠癌患者的新辅助 治疗。达伯欣(伊匹木单抗N01注射液)是中国首个获批的国产抗CTLA-4单抗，也是全球首个获批的用于 结肠癌新辅助治疗的抗CTLA-4单抗，通过联合信迪利单抗的短期新辅助治疗，可显著提升病理完全缓 解率，惠及MSI-H/dMMR结肠癌患者。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 達伯欣® （伊匹木單抗N01注射液）獲中國國家藥品監督管理局批准 聯合信迪利單抗用於結腸癌新輔助治療 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈達伯欣® （伊匹木單抗N01注射液，細胞毒性T 淋巴細胞相關蛋白4（「CTLA-4」）單克隆抗體（「單抗」），研發代號：IBI310）獲得 中國國家藥品監督管理局（「NMPA」）批准上市，聯合信迪利單抗用於可手術切除 的IIB-III期微衛星高度不穩定型（「MSI-H」）或錯配修復缺陷型（「dMMR」）結腸 癌患者的新輔助治療。達伯欣® （伊匹木單抗N01注射液）是中國首個獲批的國產抗 CTLA-4單抗，也是全球首個 ...

Core Insights - The approval of the dual immunotherapy regimen for the treatment of resectable IIB-III stage MSI-H/dMMR colorectal cancer marks a significant breakthrough in the field of immunotherapy for colorectal cancer [1][3][4] - This therapy is the first and only dual immunotherapy regimen approved globally for neoadjuvant treatment in colorectal cancer, potentially changing treatment paradigms for patients with this specific cancer type [1][3] Group 1: Treatment Approval and Characteristics - The National Medical Products Administration approved the new drug application for Daberxin (Ipilimumab N01 injection), which can be used in combination with Daberush (Sintilimab injection) for neoadjuvant therapy in patients with resectable IIB-III stage MSI-H/dMMR colorectal cancer [1] - MSI-H/dMMR colorectal cancer accounts for approximately 15% of all resectable colorectal cancer cases, and these tumors are less responsive to traditional chemotherapy [1][3] Group 2: Clinical Implications and Efficacy - Existing treatments for locally advanced MSI-H/dMMR colorectal cancer primarily involve radical surgery and postoperative adjuvant chemotherapy, with a recurrence or metastasis rate of 10%-30% among patients [3] - The dual immunotherapy regimen has shown to significantly increase the pathological complete response rate in neoadjuvant therapy, potentially reducing the need for postoperative adjuvant chemotherapy [3][4] Group 3: Patient Considerations and Safety - For patients with MSI-H/dMMR colorectal cancer, surgery may not be the only option due to the challenges associated with radical surgery and poor prognosis [4] - While the dual immunotherapy regimen is generally considered safe and controllable, there are potential immune-related adverse reactions that may occur, necessitating timely medical intervention for severe cases [4]

Group 1 - The core point of the news is that Innovent Biologics has received approval from the National Medical Products Administration (NMPA) for its self-developed anti-CTLA-4 monoclonal antibody, Daberhe, in combination with the PD-1 inhibitor, Dabeoshu, for neoadjuvant treatment of resectable IIB-III stage microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients, marking a significant milestone in China's oncology treatment landscape [1][2] - Daberhe becomes the first domestically approved anti-CTLA-4 inhibitor in China and represents the world's first "dual immunotherapy" neoadjuvant treatment regimen for this indication [1] - The combination of Daberhe and Dabeoshu is now the ninth approved indication for Dabeoshu in China, which has already been approved for multiple indications including lung cancer, liver cancer, and esophageal cancer [1] Group 2 - With the approval of Daberhe, Innovent Biologics has successfully launched seven innovative drugs by 2025, focusing on key disease areas such as oncology (PD-1 and CTLA-4 combination), metabolism (GCG/GLP-1 dual-target drugs), autoimmune diseases (IL-23p19), and ophthalmology (Tebentafusp N01) [2] - The company is transitioning from a single focus on oncology to a dual-driven model of "oncology + chronic diseases," with plans to establish a comprehensive commercialization platform for chronic diseases [2] - As of now, Innovent Biologics has a total of 18 innovative drugs approved for market, and with the ongoing strengthening of its R&D and commercialization systems, the company is expected to further expand its leading position in the domestic biopharmaceutical industry [2]

Group 1 - The approval of the anti-CTLA-4 monoclonal antibody Daberxin (Ipilimumab N01 injection) by the National Medical Products Administration (NMPA) marks it as the first domestically developed anti-CTLA-4 inhibitor approved in China, providing a significant breakthrough in neoadjuvant treatment for resectable IIB-III stage microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients [1][2] - The approval is based on the interim analysis results of the Phase III registration study NeoShot-III, which showed that 82% of the first 50 patients receiving the "dual immune" neoadjuvant therapy achieved pathological complete response (pCR), with no additional safety risks compared to direct surgery [2] - The combination of Daberxin and the PD-1 inhibitor DabuShu (Sintilimab injection) is expected to change clinical practice and fill the gap in neoadjuvant treatment for colorectal cancer, benefiting more patients [2] Group 2 - As of 2025, the company has successfully launched 7 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 model of "oncology + chronic diseases," aiming to become a leader in the chronic disease innovation sector [3] - The company has set a target of exceeding 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]