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 - 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]

Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients, 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 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 - Innovent Biologics (01801.HK) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients when combined 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 therapy in colorectal cancer [1] - The combination therapy 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 Viewpoint - The National Medical Products Administration (NMPA) has approved the launch of the anti-CTLA-4 monoclonal antibody, Ipilimumab N01 injection (brand name: Daberxin), developed by Innovent Biologics, for neoadjuvant treatment in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, marking it as China's first domestically approved anti-CTLA-4 monoclonal antibody and the first globally for this indication [1][5]. Group 1 - The approval is based on the results of a randomized, controlled, multi-center Phase III registration study (NeoShot-III, NCT05890742) conducted in China, which aimed to evaluate the efficacy and safety of Ipilimumab N01 in combination with Sintilimab compared to direct radical surgery [3][7]. - The primary endpoints of the study included pathological complete response (pCR) and event-free survival (EFS) [3][7]. - The interim analysis of the NeoShot-III study showed that the predefined primary endpoints were met, as assessed by the Independent Data Monitoring Committee (iDMC) [3][7]. Group 2 - As of November 28, 2024, among the first 50 patients in the trial group, 41 achieved pathological complete response after neoadjuvant treatment, resulting in a pCR rate of 82% [4][8]. - In terms of safety, the combination of Ipilimumab N01 and Sintilimab did not significantly increase additional safety risks compared to the direct surgery group [4][8]. - The Chief R&D Officer of Innovent Biologics, Dr. Zhou Hui, emphasized the significant unmet clinical need for neoadjuvant treatment in resectable MSI-H/dMMR colorectal cancer, highlighting the importance of the NeoShot-III study's interim analysis for this treatment area [4][8].

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]

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].

Core Insights - 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 [2][3] Group 1: Drug Approval and Clinical Impact - Daberxin® is now part of the first "dual immunotherapy" neoadjuvant treatment regimen approved globally for this indication, which is expected to change clinical practices and fill a gap in the neoadjuvant treatment landscape for colorectal cancer [2][3] - In a phase III registration study (NeoShot-III), 82% of the first 50 patients treated with the "dual immunotherapy" showed no residual tumors in surgical specimens, achieving pathological complete response (pCR), with no additional safety risks compared to direct surgery [3] Group 2: Company Development and Market Position - As of now, the company has successfully launched 7 innovative drugs by 2025, with a focus on oncology, metabolism, autoimmune diseases, and ophthalmology, indicating a robust pipeline and commercialization strategy [4] - The company is transitioning from a single-focus on oncology to a dual-drive model that includes chronic diseases, aiming to establish a comprehensive commercialization platform in this area [4] - With the ongoing launch of new chronic disease products and stable contributions from core oncology products, the company's goal of exceeding 20 billion yuan in product revenue by 2027 is becoming increasingly realistic [4][5]

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]