Xuanzhu Biopharmaceutical Co., Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., has achieved a significant milestone with the approval of its Class 1 innovative drug, Bireociclib Tablets. The New Drug Application (NDA) for Bireociclib, also known as Xuan Yue Ning, has been approved by the National Medical Products Administration (NMPA) for use as monotherapy and in combination with Fulvestrant for two indications in HR+/HER2- advanced breast cancer. This development underscores Xuanzhu Biopharmaceutical's commitment to advancing cancer treatment options and highlights its capabilities in independent drug development.
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