On May 15, 2025, Xuanzhu Biopharm reported the latest announcement released by the National Medical Products Administration attracted widespread attention in the oncology community and the pharmaceutical market (Press release, Xuanzhu Biopharmaceutical, MAY 15, 2025, View Source [SID1234653189]). Bireociclib tablets (trade name: Xuanyuening), a Class 1 anti-tumor new drug independently developed by Xuanzhu Biopharmaceutical was officially approved for marketing. This innovative drug is indicated for two important conditions in HR+/HER2- breast cancer. It not only injects new vitality into the domestic breast cancer treatment field but also brings new hope to a large number of breast cancer patients.
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Bireociclib tablets are applicable to adult patients with advanced or metastatic breast cancer who are positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). On the one hand, it can be combined with fulvestrant for patients with disease progression after previous endocrine therapy. On the other hand, it is the only CDK4/6 inhibitor approved in China as monotherapy for the patients with disease progression after receiving two or more endocrine therapies and one chemotherapy in the metastatic stage. According to authoritative data, approximately 420,000 new breast cancer cases are diagnosed in China each year, among which nearly 100,000 are advanced breast cancer patients. The launch of Bireociclib tablets undoubtedly provides a new and effective treatment option for this large patient group.
Globally, breast cancer is the most common malignant tumor among women, with approximately 70% being the hormone receptor-positive subtype. Although the advent of CDK4/6 inhibitors has significantly extended patients’ survival, current treatments still face many challenges. The efficacy of existing drugs is limited in premenopausal patients; patients with visceral crisis have a poor prognosis; some patients have difficulty tolerating the adverse reactions of the drugs; and the problem of primary drug resistance is also prominent. Bireociclib tablets, with their innovative multi-target mechanism of action (acting on CDK2, 4, 6, and 9), can precisely block the tumor cell proliferation pathway while significantly reducing the incidence of hematological toxicity. This not only achieves a strong and continuous inhibition of tumors but also greatly improves patients’