Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August 2020 and received conditional market approval in China in July 2022.
Indication and Initial Prescription
Cosela is indicated for adult patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not previously been treated with systemic chemotherapy. The drug was first prescribed in China in January 2023, marking a significant advancement in the treatment options available for this patient population.
Phase III TRACES Study and Regulatory Filings
Trilaciclib has completed the data analysis from the Phase III TRACES study, and the related data was filed with the NMPA in January 2023. The drug is also awaiting regulatory decisions as a treatment for ES-SCLC when administered prior to topotecan, with the aim of reducing the incidence of chemotherapy-induced bone marrow suppression in China.-Fineline Info & Tech
