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]
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