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信达生物:创新药达伯特成为澳门首个获批的中国企业自主研发的KRAS G12C抑制剂
Cai Jing Wang· 2025-07-09 02:31
Core Insights - The first KRAS G12C inhibitor developed by a Chinese company, Fulzerasib, has been approved for marketing in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations [1][2] Group 1: Product Approval and Clinical Data - Fulzerasib specifically inhibits the oncogenic KRAS G12C protein, blocking tumor cell proliferation signals and addressing the limitations of traditional treatment methods [1] - In a Phase II clinical trial for Chinese patients with KRAS G12C-mutated advanced NSCLC, Fulzerasib demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, a 12-month overall survival (OS) rate exceeding 54.4%, and a 12-month duration of response (DoR) rate of 53.7% [1] Group 2: Safety and Recommendations - The treatment-related adverse events were primarily grade 1-2, including anemia and various examination-related adverse reactions, which were effectively managed through dose adjustments and supportive care, with no unexpected severe toxic reactions observed [2] - Fulzerasib has received a level 1 recommendation for the treatment of KRAS G12C mutations in the recently published 2025 CSCO guidelines for non-small cell lung cancer, offering a new option that combines precision targeting, durable efficacy, and good tolerability for patients [2] Group 3: Market Expansion and Future Prospects - The approval of Fulzerasib in Macau marks a significant breakthrough for the company's innovative drugs in the Greater China region [2] - The company has multiple innovative products, including Daberu® and Dazhuo® that have been approved in various regions such as Indonesia, Hong Kong, Macau, and Taiwan, with additional products under registration in Brazil, Mexico, Colombia, and India, potentially bringing more innovative therapies to patients in Latin America and Southeast Asia [2]