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COSELA® granted full approval by NMPA

Release time:2023-11-07

COSELA® granted full approval by NMPA

On Oct 30 2023,Simcere Zaiming, an innovative oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd.(Simcere), announced that the new drug application of COSELA® (Trilaciclib Hydrochloride for Injection), an innovative drug co-developed by Simcere and G1 Therapeutics and currently marketed in China by Simcere Zaiming has been cleared by the National Medical Products Administration of China (the “NMPA”) to change from conditional approval to regular approval.


COSELA® is a first-in-class short-acting and reversible cyclin-dependent kinase CDK4/6 inhibitor for bone marrow protection when administered prior to chemotherapy. It has received a “Breakthrough Therapy” designation by the US FDA and marketed in the US since February 2021. On July 12, 2022, COSELA® obtained the conditional approval by NMPA after priority review. The indication is to decrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide-containing regimen for patients with extensive-stage small cell lung cancer (“ES-SCLC”), who have not previously received systemic chemotherapy.


In January 2023, Simcere Zaiming submitted the supplement data of phase 3 results of trilaciclib in Chinese patients with ES-SCLC receiving chemotherapy (TRACES study). The updated data of TRACE study was published at the 2023 European Society for Medical Oncology (ESMO) Congress. Compared with placebo group, trilaciclib group had fewer cycle delays (E/P: 30.4% vs 73.9%; TPT: 44.4% vs 73.7%) and dose reductions (E/P: 30.4% vs 73.9%; TPT: 44.4% vs 73.7%). After a median follow-up of 14.1 months, the median overall survival was 12.0 months in the trilaciclib group and 8.8 months in the placebo group (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.40 to 1.22). The median progression-free survival was 4.8 months and 4.3 months, respectively (HR, 0.86; 95% CI, 0.53 to 1.39). The latest data revealed that administering trilaciclib prior to chemotherapy in ES-SCLC patients improved patients’ tolerability to chemotherapy, and suggested potential survival benefit.


COSELA® has been recommended by multiple key guidelines in China and the US, including

        NCCN Guideline for Hematopoietic Growth Factors(2022)

        NCCN Guideline for Small Cell Lung Cancer (2022)

        CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer (2022)

        Chinese Expert Consensus on Diagnosis and Treatment of Neutropenia Caused by Cancer Chemotherapy (2023)

        Chinese Medical Association Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2023)

        Systemic Therapy for Small-Cell Lung Cancer: ASCO-Ontario Health (Cancer Care Ontario) Guideline