December 27, 2023, Simcere Zaiming Pharmaceutical Co., Ltd. (“Simcere Zaiming"), an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that COSELA® (Trilaciclib Hydrochloride for Injection), an innovative oncology product co-developed by Simcere and G1 Therapeutics and currently marketed in China by Simcere Zaiming has obtained the approval notice of Supplementary Application of Drugs issued by the National Medical Products Administration of China (the “NMPA”). The transfer of COSELA’s production technology from G1 Therapeutics Inc. to Hainan Simcere Pharmaceutical Co., Ltd. has been approved in China. In the future, COSELA® can be manufactured locally in Hainan China which will vastly improve drug accessibility to cancer patients in China.
About COSELA®
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 conditional approval from NMPA after a priority review. On October 27, 2023, COSELA® was approved by the NMPA to transit from conditional approval to regular approval.
The product 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
ABOUT G1
G1 is a biopharmaceutical company at the commercial stage focused on the discovery, development, and delivery of next-generation therapies designed to improve the lives of cancer patients.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited. Founded in 2023, the Company is committed to developing disruptive therapies that have the potential to address unmet clinical needs for cancer patients around the world. Simcere Zaiming has built an innovative R&D pipeline, with differentiated clinical assets. Several products of Simcere Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatment options to cancer patients worldwide through in-house R&D, manufacturing, and commercialization, as well as collaborations with global partners of innovative cancer therapeutics.Media contact: pr@zaiming.com