By Fineline Cube 
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ) has announced that its Category 1 drug, culmerciclib (TQB3616), has received acceptance for review by the National Medical Products Administration (NMPA). The company is seeking approval for an expanded indication of the drug as a first-line endocrine therapy in combination with fulvestrant for HR+/HER2- locally advanced or metastatic breast cancer.
Approval Details
The latest filing marks a significant milestone for culmerciclib, which has already been under regulatory review for its initial indication since July 2024. The drug is being evaluated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer in patients who have previously received endocrine therapy, also in combination with fulvestrant.
Drug Mechanism and Differentiation
Culmerciclib is a novel cyclin-dependent kinase 2, 4, and 6 (CDK2/4/6) inhibitor designed to enhance the inhibitory effect on CDK2 compared to abemaciclib. This unique mechanism of action could potentially offer improved efficacy for patients with HR+/HER2- breast cancer, making it a promising addition to the treatment landscape.
Development Milestones
The acceptance of this new indication filing underscores Jiangsu Chia Tai Tianqing’s commitment to advancing innovative therapies for breast cancer. With its first indication already under review, culmerciclib has the potential to become a key player in the management of HR+/HER2- breast cancer in China and beyond.-Fineline Info & Tech