China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela (trilaciclib), enabling the transfer of its manufacturing technology from G1 Therapeutics to Simcere’s facility in Hainan. This transition paves the way for localized production of the CDK4/6 inhibitor, enhancing patient accessibility across the region.
Trilaciclib, originally discovered by U.S. biotech firm G1 Therapeutics Inc., was in-licensed by Simcere in August 2020. The drug received conditional market approval in China in July 2022 for adult patients with extensive-stage small-cell lung cancer (ES-SCLC) who had not previously undergone systemic chemotherapy. It was first prescribed in China in January 2023, and in October, its status was upgraded to regular approval for the treatment of ES-SCLC.- Flcube.com
