Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients who have previously received endocrine therapy. The National Medical Products Administration (NMPA) has accepted the filing for review.
BPI-16350 has demonstrated good selectivity at the kinase level within the CDK family, showing comparable inhibitory activity against CDK4/6 to abemaciclib, a marketed CDK4/6 inhibitor. Furthermore, BPI-16350’s subtype selectivity is considered superior, potentially offering a differentiated therapeutic option for patients with the specified breast cancer indication.- Flcube.com
