By Fineline Cube Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China’s first “Overseas Version” drug price certificate issued by the China Medicine Registration (CNMR) system, according to the National Healthcare Security Administration (NHSA). The certificate is expected to accelerate the product’s entry into international markets.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Beijing Merson Pharmaceutical Co., Ltd. |
| Product | Bemejing (timolol maleate gel) |
| Certificate | First “Overseas Version” drug price certificate (CNMR) |
| Issuing Authority | National Healthcare Security Administration (NHSA) |
| Approval Date | Last September 2025 (China marketing approval) |
| Indication | Superficial infantile hemangiomas |
| Global Incidence | 5‑12% (common benign tumor) |
| Certificate Date | Week of 13 Jan 2026 |
| System Launch | CNMR launched Dec 2025 |
CNMR System Overview
- Model: Single‑point acceptance, nationwide sharing, global disclosure
- Purpose: Creates drug‑price archives to provide pricing references for Chinese firms seeking overseas market access
- Current Status (as of Jan 18, 2026):
- 60 pharma companies registered
- 22 drug products listed
- 14 products with publicly available price details
- Strategic Value: First certificate awarded to Bemejing validates CNMR’s role in facilitating global expansion for domestic innovators
Drug Profile & Market Context
- Mechanism: Timolol maleate gel – non‑selective beta‑blocker that constricts blood vessels and inhibits angiogenesis, reducing hemangioma growth
- Advantage: Topical formulation offers safety and convenience vs. oral propranolol (standard of care)
- Differentiation: First topical beta‑blocker approved for infantile hemangiomas in China
- Global Standard: Competing products include Hemangeol (oral propranolol, US/EU) and Timoptic (ophthalmic solution, off‑label use)
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Infantile Hemangiomas (Annual Cases) | 950,000 | 6.8 million |
| Superficial (Topical‑Eligible) | 380,000 | 2.7 million |
| Current Standard | Oral propranolol (side effects, monitoring burden) | |
| Bemejing Market Share | 0% | 0% |
| Addressable Market (2030E) | ¥1.2 billion | $850 million |
| Bemejing Peak Revenue | ¥480 million | $170 million |
- Pricing: CNMR certificate enables transparent pricing reference (estimated ¥200‑300/tube) for registration in ASEAN, Latin America, and Middle East
- Regulatory Pathway: Certificate streamlines pricing negotiations in target markets, potentially reducing time‑to‑market by 12‑18 months
Strategic Positioning
- Manufacturing: Merson’s Beijing topical gel facility (capacity 5 million tubes/year) meets US FDA and EU GMP standards, enabling dual‑market supply
- Global Expansion: CNMR certificate positions Bemejing as reference‑priced innovator for WHO Pre‑qualification and UNICEF procurement
- Pipeline Leverage: Success builds Merson’s pediatric dermatology franchise, supporting follow‑on products for vascular malformations and port‑wine stains
- Next Steps:
- ASEAN filing: Q2 2026 (Singapore, Malaysia, Thailand)
- Latin America: Q4 2026 (Brazil, Mexico)
- EU decentralized procedure: H1 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding CNMR certificate benefits, international market penetration, and revenue forecasts for Bemejing. Actual results may differ due to regulatory acceptance of CNMR pricing, competitive responses, and market access challenges.-Fineline Info & Tech