#China #Hong Kong #Breast Cancer #Xuanzhu Biopharm #Xuanyuening

Xuanzhu Biopharm's Groundbreaking Approval for Xuanyuening®

On May 15, 2025, the National Medical Products Administration in China made a significant announcement that caught the eye of the oncology sector and pharmaceutical markets alike. Xuanzhu Biopharmaceutical, a key player in the biopharmaceutical scene, has received official approval to market its novel anti-tumor medication, Xuanyuening® (Bireociclib Tablets). This drug is particularly important as it has been authorized for treatment of two vital conditions in HR+/HER2- breast cancer.

Bireociclib tablets represent a leap forward in the domestic treatment landscape for breast cancer, offering renewed possibilities to patients battling this challenging disease. Targeting adult patients with advanced or metastatic breast cancer, the drug is specifically designed for individuals who test positive for hormone receptors while being negative for the human epidermal growth factor receptor 2 (HER2). The innovative treatment can be used in two distinctive ways. First, it can be combined with fulvestrant for those who experience disease progression after previous endocrine therapies. Additionally, it stands as the only CDK4/6 inhibitor in China sanctioned as a standalone treatment for patients who have had disease progression after undergoing two endocrine therapies and one chemotherapy regimen while in the metastatic stage.

Annual statistics highlight that around 420,000 new breast cancer cases are diagnosed in China, with about 100,000 classified as advanced breast cancer, underscoring the urgent need for effective treatment options.

Breast cancer is recognized as the most prevalent malignant tumor among women globally, with approximately 70% of those cases being the hormone receptor-positive subtype. Though CDK4/6 inhibitors such as Bireociclib have vastly improved survival rates for many patients, challenges still persist. Notably, existing treatments do not yield favorable outcomes for premenopausal women, and patients with visceral crises often face grim prognoses. Some patients also struggle to endure the side effects associated with current drugs. The innovative multi-target mechanism of action employed by Bireociclib blocks the proliferation pathway of tumor cells while minimizing hematological toxicity. This suggests that the drug not only achieves significant and sustained tumor inhibition but also enhances patient tolerance towards treatment.

The clinical trials for Bireociclib were methodically conducted to align with the unique pharmacological and epidemiological characteristics of breast cancer patients in China. Notably, studies found that Chinese patients typically present with younger median ages at diagnosis, heightened instances of Luminal B-type tumors, and more frequent cases of primary drug resistance.

Among the clinical trial population, a significant percentage included patients who had previously undergone advanced chemotherapy (23.9%), those who were primary drug-resistant (25.6%), premenopausal patients (37%), and patients with visceral metastases (68.2%). Impressively, in second-line treatment collaborations, the median progression-free survival reached 14.7 months, according to researchers; a measure taken by the Blinded Independent Review Committee (BIRC) indicated an even longer duration of 17.5 months. A standout feature of Bireociclib is its groundbreaking achievement as a single-drug treatment option, yielding up to 11 months of progression-free survival, a notable record in the realm of similar therapies.

The market potential for Bireociclib is vast as breast cancer rates continue to climb and patients seek out more effective solutions. Market research anticipates that the market for CDK4/6 inhibitors in China will grow into the tens of billions in the next five years. With its dual indications and high efficacy, Bireociclib is poised to capture substantial market share.

In addition, Xuanzhu Biopharm is actively seeking to integrate Bireociclib into the national medical insurance system to ensure that patients receive treatment that is accessible, affordable, and effective. This initiative reflects both corporate social responsibility and the intent to further promote the use of Bireociclib in clinical settings, potentially transforming the landscape of breast cancer treatment in China.

About Xuanzhu Biopharmaceutical

As an innovative drug subsidiary of Sihuan Pharmaceutical, Xuanzhu Biopharmaceutical aims at addressing major diseases through its robust research and development endeavors. With a focus on drugs targeting digestion, oncology, and non-alcoholic steatohepatitis, the company holds commitment to producing class 1 drugs that utilize proprietary intellectual property. Its highly experienced R&D team utilizes dual development platforms for small and large molecules to maintain a competitive product pipeline.

About Sihuan Pharmaceutical

Founded in 2001 and publicly listed in 2010, Sihuan Pharmaceutical is an internationally recognized medical aesthetic and biopharmaceutical company driven by innovation. Leveraging its extensive R&D platform, diverse global product portfolio, and efficient production capacities, Sihuan seeks to emerge as a frontrunner in the industry by promoting its dual strategy focused on medical aesthetics and biopharmaceuticals.