Analysis of the Performance Impact of Xuanzhu Biopharma's Piroxilil Tablets Inclusion in Medical Insurance

Based on the information I have collected, I provide you with a detailed analysis report on the impact of Xuanzhu Biopharma’s CDK4/6 inhibitor Piroxilil Tablets inclusion in medical insurance on its performance.

• On December 8, 2025, Sihuan Pharmaceutical officially announced that Xuanzhu Biopharma’s self-developed innovative drug Piroxilil Tablets (trade name: Xuanyuening) was first included in the National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug Catalog (2025 Edition)
• The 2025 National Basic Medical Insurance Catalog will be officially implemented on
  January 1, 2026
  [1][2]

• Both approved indications are included in the medical insurance catalog:
  1. Combined with fulvestrant for HR+/HER2- advanced or metastatic breast cancer patients who have experienced disease progression after previous endocrine therapy
  2. Monotherapy for HR+/HER2- advanced or metastatic breast cancer patients who have experienced disease progression after receiving two or more endocrine therapies and one chemotherapy in the previous metastatic stage [2]

• Pioneering Advantage
  : Piroxilil is China’s
  first and only CDK4/6 inhibitor approved for monotherapy indication
  [1][2]
• Target Advantage
  : As a new CDK2/4/6 inhibitor, it has a unique multi-target synergistic mechanism of action
• Safety Advantage
  : Potently inhibits tumor cell proliferation and significantly reduces hematological toxicity common in traditional CDK4/6 inhibitors

• The new indication application for Piroxilil combined with aromatase inhibitor (AI) for first-line treatment of HR+/HER2- advanced breast cancer is under review [2]

Inclusion in medical insurance will significantly improve the

of the drug for patients, which is particularly important for breast cancer patients who need long-term treatment. According to industry experience, innovative drugs usually achieve significant market penetration growth after medical insurance access.

The company clearly stated that the medical insurance negotiation result “is conducive to further promoting the market promotion of the drug and expanding sales scale” [1][2]. Combined with the following factors, rapid growth is expected:

• Large Patient Base
  : Breast cancer is one of the most common malignant tumors in Chinese women, with HR+/HER2- subtype accounting for about 70%
• Favorable Competitive Landscape
  : As the only CDK4/6 inhibitor approved for monotherapy indication, it has a differentiated competitive advantage
• Adequate Channel Preparation
  : Xuanzhu Biopharma has built a sales team of over 200 people [1]

From the financial data, Xuanzhu Biopharma’s R&D investment shows a stepwise downward trend:

• 2023: RMB 239 million
• 2024: RMB 186 million
• H1 2025: RMB 83.7 million [1]

This trend indicates that the company is transitioning from the R&D investment phase to the commercial harvest phase. Medical insurance access will accelerate this process and bring stable cash flow to the company.

• Xuanzhu Biopharma listed on the Hong Kong Stock Exchange in October 2025 with outstanding performance: the over-subscription rate of the public offering exceeded 4900 times, the share price soared by 126.72% on the first day, and the increase exceeded 400% only one month after listing [1]
• External investment institutions such as SDIC Fund have accumulated more than 20% equity, highlighting professional capital’s recognition of its R&D strength [1]
• The medical insurance breakthrough is both an accelerator for Xuanzhu Biopharma’s commercialization and the best window to interpret its pipeline value and growth potential

• As China’s first and only self-developed innovative proton pump inhibitor (PPI) drug, it has achieved steady growth
• Commercial performance: 2024 revenue was approximately RMB 30.1 million, H1 2025 revenue was approximately RMB 17.9 million [1]
• Successful renewal of medical insurance will further expand accessibility

• Anaprazole Sodium has covered more than 1,000 hospitals nationwide [1]
• The mature sales channel can provide a foundation for the rapid volume growth of Piroxilil Tablets
• Reduce unit sales cost and improve marketing efficiency

• The CDK4/6 inhibitor market maintains rapid growth globally and in China
• Medical insurance access has become an important catalyst for the commercialization volume growth of innovative drugs [1]
• Currently, innovative pharmaceutical companies are entering the performance realization period, and the gradual implementation of pipeline value is the core logic of the high prosperity of the sector

• Indication Expansion
  : The first-line treatment indication is under review; once approved, it will further expand the patient population
• Primary Market Penetration
  : The advantage of medical insurance pricing will start the coverage of primary markets
• Import Substitution Trend
  : As a domestic innovative drug, it has price advantages in medical insurance negotiations

• The implementation of medical insurance policies takes time, and there are uncertainties in the progress of hospital access work
• Sales team expansion and channel construction require continuous investment

• Other CDK4/6 inhibitors are also actively applying for medical insurance access
• Need to continuously pay attention to changes in the competitive landscape

• Medical insurance negotiations may lead to price reductions, affecting short-term profit margins
• Need to balance market share expansion and profitability

The inclusion of Xuanzhu Biopharma’s Piroxilil Tablets in the medical insurance catalog is an

in its commercialization process, and is expected to have a significant positive impact on its performance:

1. Short-term Impact (2026)
   : Achieve market breakthrough from 0 to 1, with expected rapid expansion of sales scale
2. Medium-term Impact (2027-2028)
   : Form a stable revenue source with the expansion of indications and deepening of channels
3. Long-term Impact
   : As the core product of the company’s innovative drug platform, it will support Xuanzhu Biopharma’s transition to the Biopharma stage with cash creation capabilities

Considering Xuanzhu Biopharma’s mature sales network, differentiated product advantages, and the commercial support capabilities of its parent company Sihuan Pharmaceutical, the medical insurance access of Piroxilil Tablets is expected to become an important engine for the company’s performance growth and create sustainable value returns for shareholders.

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[1] Huayi Family - Xuanzhu Biopharma’s Two Core Products Successfully Admitted to 2025 National Medical Insurance Catalog (https://bydrug.pharmcube.com/news/detail/0e6e2d333984489a133bb302df59494e)

[2] Sihuan Pharmaceutical Voluntary Announcement - Innovative Drug Xuanyuening First Included in National Basic Medical Insurance Drug Catalog (https://www1.hkexnews.hk/listedco/listconews/sehk/2025/1208/2025120800381_c.pdf)

[3] Gelonghui - Sihuan Pharmaceutical (00460.HK): Innovative Drug Xuanyuening First Included in National Basic Medical Insurance Drug Catalog (https://caifuhao.eastmoney.com/news/20251208164804376212880)