China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone sensitive prostate cancer (mHSPC) who have a high tumor burden.
Dalpiciclib: China’s First Domestically-Developed CDK 4/6 Inhibitor
Dalpiciclib is the first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor in China. It obtained market approval in China in December 2021 with priority review status for use in HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy, combined with fulvestrant. In June this year, the drug received another indication to treat patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer as an initial therapy combined with an aromatase inhibitor.
Modified Abiraterone and Its Benefits
Hengrui’s modified version of abiraterone has been designed to enhance gastrointestinal absorption rates, improve oral bioavailability, and reduce the impact of food on its pharmacokinetics, thereby reducing individual variation in drug response. This modified version of abiraterone is not available on the market anywhere in the world, making it a unique offering in the treatment landscape.-Fineline Info & Tech
