Xuanzhu Biopharm's Xuanyuening® (BireociclibTablets) Approved for Dual Indications, Bringing Innovative Breakthroughs to Breast Cancer Treatment

Rhea-AI Summary

Xuanzhu Biopharm's Bireociclib tablets (Xuanyuening®) received NMPA approval on May 15, 2025, for two key indications in HR+/HER2- breast cancer treatment. The drug can be used in combination with fulvestrant for patients with disease progression after endocrine therapy, and uniquely, as a monotherapy for patients who progressed after two+ endocrine therapies and chemotherapy. The innovative multi-target mechanism (CDK2, 4, 6, and 9) demonstrated strong clinical results, with combination therapy showing 14.7-17.5 months median progression-free survival in second-line treatment, and notably, 11 months progression-free survival in single-drug posterior line treatment. The drug addresses specific needs of Chinese patients, who typically have earlier onset and higher rates of primary drug resistance. With 420,000 new breast cancer cases annually in China, including 100,000 advanced cases, the market potential is significant.

Positive

• Dual indication approval for HR+/HER2- breast cancer treatment, expanding market potential
• Unique approval as monotherapy for later-line treatment, differentiating from competitors
• Strong efficacy with 14.7-17.5 months progression-free survival in combination therapy
• Record-breaking 11 months progression-free survival in single-drug posterior line treatment
• Lower incidence of hematological toxicity, improving patient tolerance
• Large addressable market with 420,000 new breast cancer cases annually in China
• Company pursuing national medical insurance system inclusion to increase accessibility

Negative

• Faces competition in established CDK4/6 inhibitor market
• Market penetration dependent on successful inclusion in national medical insurance system
• Limited to specific breast cancer subtypes (HR+/HER2-)

HONG KONG, May 15, 2025 /PRNewswire/ -- On May 15, 2025, the latest announcement released by the 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.

About Xuanzhu Biopharm

Xuanzhu Biopharmaceutical is the innovative drug subsidiary of Sihuan Pharmaceutical. It is an innovative pharmaceutical company with roots in China and a global perspective, focusing on major diseases such as digestion, oncology and non-alcoholic steatohepatitis, and is committed to the research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights. The company has a first-class R&D team, all core personnel have years of experience in new drug research and development. The company has two R&D platforms: small molecule chemistry and large molecule biologics. The dual engines drive the company's innovation and development, forming a product pipeline that covers small molecule chemistry, large molecule biopharmaceuticals, antibody-drug conjugate (ADC) and other types of products. With a focus on unmet major clinical needs, the company is committed to developing into a first-class innovative pharmaceutical company with independent research and development, production, and sales capabilities.

About Sihuan Pharmaceutical

Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical is an international medical aesthetic and pharmaceutical company led by innovation, with an independent and leading research and development technology platform, a rich global product pipeline, strong product registration capability, a full dosage form production platform with high efficiency and low cost and a mature and excellent sales system. Adhering to the overall strategic goal for the "full promotion of a two-wheel drive strategy of its medical aesthetics and biopharmaceutical businesses", Sihuan Pharmaceutical endeavors to build itself into a leading medical aesthetics and biopharmaceutical company in China.

Contact: Sihuan IR Department
T: +852 36283911
E: ir@sihuanpharm.com 

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SOURCE Sihuan Pharmaceutical Holdings Group Ltd.

FAQ

What are the approved indications for Xuanzhu Biopharm's (SHPHY) Bireociclib tablets?

Bireociclib is approved for HR+/HER2- breast cancer in two indications: 1) In combination with fulvestrant for patients progressing after endocrine therapy, and 2) As monotherapy for patients who progressed after two+ endocrine therapies and chemotherapy.

How effective is Bireociclib in treating breast cancer patients?

In combination therapy, Bireociclib achieved 14.7-17.5 months median progression-free survival in second-line treatment. As monotherapy, it showed 11 months progression-free survival in posterior line treatment.

What makes Xuanzhu's Bireociclib different from other CDK4/6 inhibitors?

Bireociclib has a unique multi-target mechanism acting on CDK2, 4, 6, and 9, reducing hematological toxicity. It's the only CDK4/6 inhibitor approved in China as monotherapy for later-line treatment.

What is the market potential for Bireociclib in China?

With 420,000 new breast cancer cases annually in China, including 100,000 advanced cases, the CDK4/6 inhibitor market is expected to reach tens of billions of yuan in the next five years.

How does Bireociclib address specific needs of Chinese breast cancer patients?

The drug was tested specifically for Chinese patients, who have earlier onset age, higher Luminal B-type tumors, more primary drug resistance, and higher chemotherapy populations compared to Western patients.