Dawn of a New Era: Xuanyuening® Unleashes Dual-Action Power Against Breast Cancer!
- Historic Approval: Xuanzhu Biopharm's Xuanyuening® (Bireociclib tablets) greenlit on May 15, 2025, by China's NMPA for two vital breast cancer indications1, 7.
- Dual-Front Attack: The drug tackles HR+/HER2- advanced or metastatic breast cancer, both in combination and as a pioneering monotherapy1, 7.
- Renewed Hope: This breakthrough offers a potent new weapon for patients, especially those with limited options after multiple treatments.
In a landmark decision that reverberates with hope, Xuanzhu Biopharm's independently developed Class 1 anti-tumor drug, Xuanyuening® (Bireociclib tablets), has been officially approved for marketing, heralding a significant leap forward in the battle against breast cancer in China1, 7. This isn't just another drug; it's a beacon for nearly 100,000 advanced breast cancer patients diagnosed annually in the nation, many of whom face a grim prognosis after exhausting existing therapies1.
Xuanyuening® storms onto the scene with a unique dual-indication approval. It can be combined with fulvestrant for patients whose disease has progressed after prior endocrine therapy. Crucially, it stands alone as the only CDK4/6 inhibitor in China approved as a monotherapy for patients whose cancer has advanced after two or more endocrine therapies and one chemotherapy in the metastatic stage1, 7. This offers a vital new lifeline where previous options dwindled.
The power of Bireociclib lies in its innovative multi-target mechanism, hitting CDK2, CDK4, CDK6, and CDK9, effectively choking tumor cell proliferation while impressively reducing hematological toxicity1. Clinical trials underscore its might: combination therapy delivered a median progression-free survival (PFS) of up to 17.5 months, while monotherapy achieved an astounding 11-month PFS in later-line treatment – a new global benchmark for similar therapies1. Tailored to the specific challenges of Chinese patients, who often present with earlier onset and higher primary drug resistance, Xuanyuening® brings targeted efficacy where it's desperately needed1.
Developed by Xuanzhu Biopharmaceutical, the innovative arm of Sihuan Pharmaceutical, Xuanyuening® is more than a medical triumph; it's a commitment to the "Healthy China" strategy, aiming to make this life-altering treatment accessible and affordable1. A new chapter in breast cancer treatment has begun.
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