Xuanzhu Biopharmaceutical Co., Ltd.

Sihuan Pharmaceutical's Bireociclib Receives NMPA Approval for First-Line HR+/HER2- Advanced Breast Cancer Treatment

- China's NMPA has approved Bireociclib (Xuanyuening) in combination with aromatase inhibitors for first-line treatment of HR+/HER2- advanced breast cancer, making it the first and only drug in China covering all treatment lines for this indication. - The Phase III BRIGHT-3 trial demonstrated that Bireociclib reduced disease progression or death risk by 47% overall and 64% in liver metastases patients, with median progression-free survival not yet reached in the treatment group. - The approval positions Bireociclib to capture a significant share of China's CDK4/6 inhibitor market, projected to reach RMB 13 billion by 2032, with the drug already included in China's National Reimbursement Drug List effective January 2026.