China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted an indication approval filing for its drug Cosela (trilaciclib). The CDK4/6 inhibitor is under development to treat extensive-stage small-cell lung cancer (ES-SCLC), with the aim of reducing the incidence of chemotherapy-induced bone marrow suppression when administered prior to topotecan.
Trilaciclib’s Background and Licensing Deal
Trilaciclib was discovered by US biotech company G1 Therapeutics Inc and was in-licensed by Simcere in an agreement reached in August 2020. This strategic partnership has positioned Simcere to expand its oncology portfolio and bring innovative treatments to patients in China.
Market Approval and Clinical Use in China
The drug obtained conditional market approval in China in July 2022, indicated for adult patients with ES-SCLC who have not previously received systemic chemotherapy. Cosela was first prescribed in China in January 2023, marking a significant step in providing patients with a new treatment option for this aggressive form of lung cancer.-Fineline Info & Tech
