According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382) is on track to secure priority review status for its KRAS G12C inhibitor, D-1553, aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly in patients experiencing disease progression or intolerance after prior first-line systemic treatment. This priority status underscores the drug’s recent breakthrough therapy designation (BTD) in China and its eligibility for potential conditional market approval.
D-1553, the first of its kind to advance to clinical trials in China, is currently enrolled in global multi-center clinical studies across the U.S., Australia, South Korea, mainland China, and Taiwan, targeting various cancers including NSCLC and colorectal cancer (CRC) associated with KRAS G12C mutations. Earlier this August, Chia Tai Tianqing, a China-based firm, entered into a licensing agreement with InventisBio, acquiring exclusive rights for development, regulatory affairs, manufacturing, and commercialization of the drug in mainland China.- Flcube.com
