2025年12月获纳入恒生指数成分股的信达生物（01801.HK）发布公告指，其2025年第4季和2025年全年产品收入实现强劲 增长，但其股价却并未因此而有起色，于2月5日收跌0.93%，报79.90港元，市值1,386亿港元。 全年营收破百亿 该公司预计，其2025年全年实现总产品收入约119亿元（单位人民币，下同），同比保持约45%的增长态势，我们留意到， 其2024年的产品销售收入增幅为43.64%，2025年上半年增幅为37.32%，这意味着其下半年的产品销售收入增长加快。 2025年第4季，信达生物有六款新药首次纳入2026年国家医保目录，因而计提了相应金额的一次性库存不差，即便如此，其 第4季总产品收入或仍达33亿元，同比增长60%以上，显著高于前三个季度。 值得留意的是，信达生物当前的商业化产品组合或已扩展至18款，第4季或新增达伯欣（伊匹木单抗N01注射液）和信美悦 （匹康奇拜单抗注射液）获准上市。 2025年12月29日，信达生物公告称，达伯欣（伊匹木单抗N01注射液）获国家药监局（NMPA）批准上市，根据公司提供的 资料，达伯欣或是中国第一款获批的国产抗CTLA-4单抗，也是全球第一个获 ...

Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has received approval from the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer, in combination with Sintilimab [1] Group 1 - IBI310 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 treatment of colorectal cancer [1] - The combination therapy with Sintilimab significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

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]