Prediction of Sales Volume Growth Rhythm of Xuanshu Bio's Piroxil After Inclusion in National Medical Insurance

Based on the collected information, I will systematically analyze the prediction of sales volume growth rhythm of Xuanshu Bio’s Piroxil after its inclusion in national medical insurance.

is an innovative drug independently developed by Xuanshu Bio. It was successfully included in the National Basic Medical Insurance, Maternity Insurance and Work-related Injury Insurance Drug Catalog (2025) for the first time in 2025 and will be [1][2].

• Belongs to CDK2/4/6/9 multi-target inhibitor
• Mainly used for the treatment of
  advanced HR+/HER2- breast cancer
• Fills the treatment needs of advanced breast cancer patients with disease progression after endocrine therapy

According to the BRIGHT-2 study data, Piroxil combined with fulvestrant treatment shows significant advantages [1]:

• Median Progression-Free Survival (PFS) reaches
  17.5 months
• Reduces the risk for patients with liver metastasis by
  57.3%
• Reduces the risk for patients with primary endocrine resistance by
  66.3%
• Reduces the risk of brain metastasis by
  83.3%
• The incidence of grade ≥3 diarrhea is only
  6.4%
  , with good safety

• The annual number of new breast cancer cases in China is about
  357,200
• Among them, about
  70% are HR+/HER2- subtype
  , corresponding to about 250,000 patients
• Advanced/metastatic patients account for about 20-25%, corresponding to about 50,000-60,000 patients

The CDK4/6 inhibitor market has multiple competing products included in medical insurance, including:

• Palbociclib (Pfizer)
• Abemaciclib (Eli Lilly)
• Dalpiciclib (Hengrui Medicine)

However, with its

and excellent clinical data, Piroxil has differentiated advantages in second-line treatment and special populations (liver metastasis, primary endocrine resistance) [1].

Based on the historical laws of commercialization of innovative drugs in China and industry research [3][4], I predict that Piroxil will show the following sales volume growth rhythm:

• Growth Speed:
  Rapid start-up period
• Growth Characteristics:
  Hospital access and patient penetration advance simultaneously
• Driving Factors:
  • Price reduction after medical insurance implementation, significantly improving patient accessibility
  • Return of pre-accumulated out-of-hospital patients to hospitals
  • Academic promotion accelerates doctors’ prescription willingness

• Growth Speed:
  High-speed growth period
  (expected year-on-year growth of 150-250%)
• Growth Characteristics:
  • Significant increase in the number of covered hospitals (expected to cover 1000-1500 hospitals)
  • Gradual establishment of clinical prescription habits
  • Increased brand awareness
• Key Indicators:
  • Monthly compound sales growth rate is expected to reach 8-12%
  • Verification of patient medication adherence data

• Growth Speed:
  Peak period
  (expected sales peak)
• Growth Characteristics:
  • Sales scale reaches a steady state
  • Market share tends to be stable
  • Competitive pressure begins to appear
• Annual Sales Estimate:
  Based on market size and penetration rate, it is expected to reach
  800 million to 1.5 billion yuan
  (specifically depending on pricing strategy and competitive pattern)

• Growth Speed:
  Mature period + intensified competition
• Risk Factors:
  • Continuous follow-up by competitors and price competition
  • Generic drugs may appear (before patent expiration)
  • Pressure from the iteration of new-generation drugs

According to industry research [4], the sales volume growth of innovative drugs after medical insurance access depends on four core capabilities:

1. Product Strength (Most Critical)
   • Piroxil has differentiated advantages in clinical data
   • Especially in second-line treatment and special populations
   • Need to continue post-marketing real-world research verification

2. Commercialization Capability
   • As a subsidiary of Sihuan Pharmaceutical, Xuanshu Bio can leverage the parent company’s mature sales network [1]
   • Sihuan Pharmaceutical has “an independent leading independent R&D technology platform, a high-efficiency and low-cost full-dosage form production platform, and a mature and excellent sales system” [1]
   • Need to pay attention to the construction progress of Xuanshu Bio’s independent commercialization team

3. Market Access Capability
   • Medical insurance access is the starting point, and subsequent hospital access is equally critical
   • The “dual-channel” policy can accelerate the layout of the out-of-hospital market
   • Need to pay attention to the progress of medical insurance implementation in various provinces and cities

4. Academic Promotion Capability
   • The CDK4/6 inhibitor market is highly competitive
   • Need to establish brand awareness through academic conferences, clinical guideline recommendations, etc.
   • Doctor education is a key breakthrough

1. Pricing Pressure:
   Medical insurance negotiations usually bring a price reduction of 50-60% [3], need to pay attention to the actual negotiation price
2. Intensified Competition:
   There are many competitors in the CDK4/6 track, need to pay attention to changes in market share
3. Payment Capability:
   The patient’s out-of-pocket portion after medical insurance reimbursement may still affect the penetration speed
4. Adherence:
   CDK4/6 inhibitors require long-term medication, so adherence management is very important

After Xuanshu Bio’s Piroxil is included in medical insurance, with its excellent clinical data and differentiated positioning, it is expected to

, with the sales peak expected to be reached , and the annual sales volume estimated to be in the range of . The key success factors lie in the continuous verification of product strength, the effective exertion of commercialization capability, and the rapid advancement of market access. It is recommended to continue to pay attention to the sales data updates after the implementation of medical insurance and the dynamics of competitors.

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[1] Jiufang Zhitou - “Good News | Xuanshu Bio’s Piroxil Tablets (Xuanyuening®) Successfully Included in National Medical Insurance Catalog!” (https://gmg.9fzt.com/dynamic/HKSE/00460/948d003b23c1ee4f051df91c46ebdedd.html)

[2] Yahoo Finance - “Xuanshu Bio: Innovative Drug ‘Xuanyuening’ First Included in National Basic Medical Insurance Drug Catalog” (https://hk.finance.yahoo.com/news/軒竹生物-創新藥-軒悅寧-首次納入國家基本醫保藥品目錄-041233120.html)

[3] Pharmcube - “From R&D Breakthrough to Value Realization: Ten-Year Review and Outlook of Commercialization of Innovative Drugs in China” (https://www.pharmcube.com/newsLibrary/detail?id=8d34a41fb03aa1576632c6b22554e4d6)

[4] Securities Market Weekly - “Heavy Signal from Third Quarter Report: Profit Inflection Point of Innovative Drugs Established, Golden Decade Begins” (https://static.weeklyonstock.com/25/1109/qdy135436.html)