National Medical Products Administration attracted widespread attention in the oncology community and the pharmaceutical market. 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.

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' tolerance to treatment, bringing new possibilities for addressing existing treatment bottlenecks.

The clinical trials of Bireociclib tablets, which were carried out in line with the characteristics of breast cancer patients in China, have highly valuable data. There are differences in the onset characteristics of breast cancer patients between China and Western countries. Chinese patients have an earlier median age of onset, a higher proportion of Luminal B-type tumors, primary drug resistance, and chemotherapy populations, which lead to a relatively poor prognosis. The clinical research of Bireociclib tablets is precisely tailored to the Chinese treatment situation. In the research group, 23.9% of patients had received advanced chemotherapy, 25.6% were primary drug-resistant patients, 37% were premenopausal patients, and 68.2% had visceral metastases. When used in combination, the median progression-free survival of second-line treatment patients reached 14.7 months (assessed by researchers), and the result evaluated by the Blinded Independent Review Committee (BIRC) was as long as 17.5 months. Notably, Bireociclib tablets achieved a breakthrough application in single-drug posterior line treatment, with patients having a progression-free survival of up to 11 months, setting a new record for similar therapies globally and providing a better solution for the posterior line treatment of advanced breast cancer worldwide.

In terms of market potential, with the increase in the incidence of breast cancer and the growing demand of patients for more effective treatment options, Bireociclib tablets have broad market prospects. According to market research institutions, the market size of CDK4/6 inhibitors in China is expected to reach tens of billions of yuan in the next five years. Bireociclib tablets, with their unique dual indications and excellent efficacy, are expected to occupy an important share in the market.

At present, Xuanzhu Bio has simultaneously launched the work of accessing the national medical insurance system, aiming to achieve the treatment goals of "accessible, affordable, and effective" for patients and actively contribute to the implementation of the "Healthy China" strategy. This initiative not only reflects the corporate social responsibility but also will further promote the widespread application of Bireociclib tablets in clinical treatment, bringing health benefits to more breast cancer patients.