Sihuan Pharmaceutical Holdings Group Ltd. has announced the approval of Bireociclib tablets (trade name: Xuanyuening®) by the National Medical Products Administration on May 15, 2025. Developed by Xuanzhu Biopharmaceutical, this innovative Class 1 anti-tumor drug is indicated for dual conditions in HR+/HER2- breast cancer. The approval marks a significant advancement in breast cancer treatment, offering new hope to patients. Clinical trials tailored to Chinese patients demonstrated impressive results, with a median progression-free survival of up to 17.5 months in certain cases. Xuanzhu Bio is working to include Bireociclib in China's national medical insurance system, aiming to make the treatment more accessible and affordable. With breast cancer incidence rising, the market for CDK4/6 inhibitors in China is projected to reach tens of billions of yuan within five years, positioning Bireociclib tablets for significant market share due to their efficacy and dual indications.
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