Xuanzhu Biopharmaceutical Gains NMPA Approval for Innovative Breast Cancer Drug

Reuters

05-15

Xuanzhu Biopharmaceutical Gains NMPA Approval for Innovative Breast Cancer Drug

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sihuan Pharmaceutical Holdings Group Ltd. published the original content used to generate this news brief on May 15, 2025, and is solely responsible for the information contained therein.

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