By Fineline Cube 
China-based Jacobio Pharma (HKG: 1167) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its glecirasib, a KRAS G12C inhibitor, for the treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation that has undergone at least one systemic treatment. This approval marks a significant milestone in the treatment landscape for NSCLC patients with this specific mutation.
Clinical Trial Results
The NMPA’s decision is based on results from a regulatory Phase II study in China. The study demonstrated that patients with second-line and above NSCLC treated with glecirasib alone achieved an objective response rate (ORR) of 49.6%, a disease control rate (DCR) of 86.3%, a median progression-free survival (PFS) of 8.2 months, and a median overall survival (OS) of 17.5 months. Additionally, the drug showed good safety and tolerability, with favorable gastrointestinal safety compared to other KRAS G12C inhibitors.
Commercial Agreement
The approval triggers an RMB 50 million (USD 6.9 million) milestone payment from Allist Pharmaceuticals Co., Ltd. Allist secured Greater China rights to glecirasib through a licensing deal with Jacobio last year.-Fineline Info & Tech