China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration (NMPA) has approved bireociclib, a Category 1 drug candidate developed by its subsidiary Xuanzhu Biopharmaceutical Co., Ltd. The approval is for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer. Bireociclib is approved for use in combination with fulvestrant in patients with disease progression after previous endocrine therapy and as a monotherapy in patients with disease progression after two or more endocrine therapies and one chemotherapy in the previous metastatic stage.
Clinical Efficacy and Significance
The NMPA’s approval makes bireociclib the only CDK4/6 inhibitor in China approved for monotherapy treatment of later-line HR+/HER2- advanced breast cancer. Clinical studies have shown impressive results, with a median progression-free survival (mPFS) of 14.7 months (investigator-assessed) and 17.5 months (blinded independent review committee-assessed) when used in combination with fulvestrant for second-line treatment. As a monotherapy, bireociclib achieved an mPFS of 11 months, setting a new global benchmark for similar therapies.-Fineline Info & Tech
