By Fineline Cube 
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Xuanyuening (bireociclib), a Category 1 drug developed by its subsidiary Xuanzhu Biopharmaceutical Co., Ltd. The new indication covers initial endocrine therapy in combination with aromatase inhibitors for HR+/HER2- advanced breast cancer and subsequent therapy for patients whose disease progressed after tamoxifen or toremifene adjuvant therapy.
Drug Mechanism and Advantages
Bireociclib is a CDK4/6 inhibitor with a unique multi-target synergistic mechanism affecting CDK2/4/6/9. It effectively suppresses tumor cell proliferation while reducing hematologic toxicity, thereby improving patient tolerability.
Market and Therapeutic Potential
With this third New Drug Application (NDA) submission, bireociclib is poised to cover the full spectrum of HR+/HER2- advanced breast cancer treatment, from first- to later-line therapies. This addresses significant unmet needs in a disease subtype that constitutes 70% of all breast cancer cases globally.-Fineline Info & Tech