By Fineline Cube 
WestVac BioPharma Co., Ltd. announced that the National Medical Products Administration (NMPA) has granted clinical‑trial approval for its acne therapeutic vaccine, co‑developed with West China Hospital of Sichuan University. The vaccine is the first acne‑targeted immunotherapy to reach the clinical stage in China.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Decision | Approval to commence Phase I clinical trials |
| Date Issued | 12 Nov 2025 |
| Product | Recombinant protein acne therapeutic vaccine |
| Partners | WestVac BioPharma & West China Hospital, Sichuan University |
| Next Milestone | Initiate first‑in‑human dosing by Q1 2026 |
Vaccine Profile & Technology
- Platform: Genetically engineered recombinant protein expressed in E. coli (or appropriate expression system).
- Target Antigen: A virulence factor uniquely expressed by the pathogenic Cutibacterium acnes (formerly Propionibacterium acnes) strain.
- Design Highlights:
- Optimized protein structure to minimize toxicity while preserving strong antigenicity.
- Single‑dose regimen intended to elicit durable immune protection.
- Microbiome‑sparing: Precisely attacks the pathogenic subtype without disrupting commensal skin flora, preserving the skin’s micro‑ecological balance.
Clinical Development Plan
| Phase | Objective | Sample Size | Estimated Completion |
|---|---|---|---|
| Phase I | Safety, tolerability, and immunogenicity in mild‑to‑moderate acne patients | 30 subjects | Q4 2026 |
| Phase II (planned) | Dose‑response, efficacy (lesion count reduction) | 120 subjects | Q2 2028 |
| Phase III (future) | Pivotal efficacy & long‑term safety across diverse ethnic groups | 600+ subjects | 2029‑30 |
Market Impact & Outlook
- Unmet Need: Acne affects > 80 % of adolescents and a sizable adult population worldwide; current therapies are topical or systemic antibiotics with resistance concerns.
- Commercial Potential: Global acne treatment market ≈ US$12 billion (2024). A first‑in‑class vaccine could capture a 5‑10 % share within five years, translating to US$600‑1,200 million in annual sales.
- Strategic Advantage:
- Microbiome‑preserving approach differentiates it from antibiotics and retinoids.
- Single‑dose administration simplifies adherence and reduces healthcare‑system burden.
- Funding Outlook: WestVac has earmarked RMB 150 million (~US$22 million) for Phase I‑II activities, with additional financing under discussion with strategic partners and venture investors.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, clinical development, and commercial expectations for the acne therapeutic vaccine. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, market acceptance, and competitive dynamics.-Fineline Info & Tech