Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for Dupert® (fulzerasib), the first KRAS G12C inhibitor in China, aimed at treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have undergone at least one systemic therapy [1][2] - The approval is based on a Phase 2 clinical study showing a confirmed objective response rate (ORR) of 49.1% and a disease control rate (DCR) of 90.5% among 116 evaluable NSCLC subjects [1][2] - Innovent has launched a total of 11 products and continues to expand its oncology portfolio, with Dupert® marking a significant advancement in targeted therapy for KRAS mutations [1][3] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, cardiovascular, metabolic, autoimmune, and ophthalmic conditions [3] - The company has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials, and 18 molecules in early clinical stages [3] - Innovent collaborates with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [3] Product Details - Fulzerasib is designed to target the KRAS G12C mutation, which is prevalent in various cancers, including 15-20% of lung cancer cases [2] - The drug has shown promising preclinical results, demonstrating high selectivity towards the G12C mutation and effectively inhibiting downstream signaling pathways to induce tumor cell apoptosis [2] - The approval process for fulzerasib included Breakthrough Therapy Designation (BTD) from the NMPA for both advanced NSCLC and colorectal cancer patients with KRAS G12C mutations [2]
China's First Approved KRAS G12C Inhibitor: Innovent Announces the Approval of Dupert® (Fulzerasib) by the National Medical Products Administration of China