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]
信达生物免疫药物达伯欣 获批 为首个国产获批上市的抗CTLA-4抑制剂