Recently, the China National Medical Products Administration (NMPA) issued a Drug Registration Certificate (Certificate No. 2026S03082), formally approving a new indication for Cosela® (trilaciclib hydrochloride for injection) “for patients with relapsed extensive-stage small cell lung cancer, administered prior to topotecan-containing chemotherapy regimens to reduce the incidence of chemotherapy-induced myelosuppression.”
After this approval, Cosela® now provides myeloprotection across all chemotherapy lines for extensive-stage small cell lung cancer (ES-SCLC), further expanding its treatment coverage across the disease continuum.
Cosela® is introduced and clinically devloped in China by Simcere in collaboration with oversea partners. It has received conditional marketing approval in China in July 2022, followed by routine approval in October 2023. At the end of 2023, the product completed the approval process for the localized technology transfer of its manufacturing process to Hainan, and locally manufactured Cosela® was first produced in April 2024. Leveraging the innovative industry model of “research and clinical use in Lecheng + manufacturing in Haikou,” Simcere has established a high-quality, self-reliant domestic supply system. At the end of 2024, Cosela® was included in the National Reimbursement Drug List (NRDL), substantially reducing the financial burden on patients. To date, Cosela® has also been incorporated into multiple authoritative clinical guidelines and consensus statements in China.