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COSELA® new indication NDA accepted by China NMPA

Release time:2023-08-15

On August 15, 2023, Simcere Zaiming Pharmaceutical Co., Ltd. announced that a New Drug Application (NDA) for new indication for COSELA® (trilaciclib hydrochloride for injection) was accepted by the China National Medical Product Administration (NMPA).


COSELA® is a first-in-class myeloprotective agent and is administered prior to chemotherapy for the comprehensive preservation of hematopoietic stem and progenitor cells. In addition to the previously approved indication for patients with extensive stage small cell lung cancer (ES-SCLC) to be treated with platinum-based drugs in combination with an etoposide regimen, the new indication is to reduce the incidence of chemotherapy-induced myelosuppression for ES-SCLC patients who are treated with topotecan-based chemotherapy regimens .


Topotecan is a standard chemotherapeutic agent widely used in the world for the second/third line treatment of ES-SCLC. Myelosuppression and the resulting neutropenia are the most common dose-limiting toxicity for topotecan.

As a highly potent, selective, and reversible CDK4/6 inhibitor, COSELA® puts CDK4/6-dependent cells, e.g., hematopoietic stem and progenitor cells (HSPCs), into temporary arrest at the G1 phase of the cell cycle, thereby reducing damage during their exposure to chemotherapy. Meanwhile, the cancer killing effects of chemotherapies on CDK4/6-insensitive ES-SCLC tumor cells are unaffected. The product received US FDA “Breakthrough Therapy” designation and was launched in the US in February 2021.


The pooled results of multiple published clinical studies on ES-SCLC showed that COSELA® significantly reduced the duration of severe neutropenia in the first cycle of chemotherapy, and reduced the incidence of severe neutropenia, grade 3/4 anemia, grade 3/4 thrombocytopenia, and the proportion of red blood cell transfusions.


In August 2020, Simcere Pharmaceutical entered into an exclusive cooperation license with G1 therapeutics to obtain the development and commercialization rights and interests of COSELA® for all indications in the Greater China. On July 12, 2022, COSELA® was conditionally approved by NMPA for the first indication. On Feb. 12, 2023, Simcere Zaiming,  an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group held a press conference announcing that COSELA® has been officially launched for commercialization in China.


The combination of COSELA® with topotecan based regimens has the potential to provide a “bulletproof jacket" against chemo-induced myelosuppression for wider ES-SCLC population without compromising the effect of chemotherapy.


In addition to ES-SCLC, several multicenter clinical trials are ongoing to explore the potential of COSELA ® to be used for patents with triple-negative breast cancer, bladder cancer, and other cancers.