By Fineline Cube Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (SHA: 603392) announced that its Human Immunodeficiency Virus (HIV Type 1+2) Antibody Oral Mucosal Transudate Test Kit has received National Medical Products Administration (NMPA) approval, marking the country’s first regulatory clearance for a self-administered, non-invasive HIV screening device.
Approval Summary
| Item | Detail |
|---|---|
| Product | HIV Type 1+2 Antibody Oral Mucosal Transudate Test Kit (Colloidal Gold Method) |
| Regulator | NMPA (China) |
| Approval Date | 26 Dec 2025 |
| Device Class | Class III In Vitro Diagnostic (IVD) |
| Significance | First China-approved HIV self-test using oral fluid |
Product Differentiation
- Technology: Colloidal gold lateral flow immunoassay
- Sample Type: Oral mucosal transudate (non-invasive, self-collected)
- Key Benefits:
- Privacy: Enables at-home testing without clinic visits
- Speed: Delivers results in approximately 15 minutes
- Safety: Eliminates need for blood draw or sharps disposal
- Coverage: Detects both HIV‑1 and HIV‑2 subtypes
- Target Use Case: Expanding HIV status awareness and linking positive cases to early treatment
Market Opportunity & Public Health Impact
China CDC estimates 1.25 million people are living with HIV (2024), with roughly 30 % unaware of their infection status. Blood-based testing at clinical sites remains the standard, creating access barriers in rural and stigmatized populations.
| Parameter | 2025E | 2027E |
|---|---|---|
| At-risk cohort (ages 15‑49) | 250 million | 245 million |
| Self-test addressable market | 15 million kits | 50 million kits |
| Wantai projected sales | ¥400 million | ¥1.8‑2.0 billion (US$250‑280 million) |
| Retail price (per kit) | ¥60‑80 | ¥50‑70 (post-volume procurement) |
The oral HIV self-test aligns with China’s 14th Five-Year Public Health Plan, which prioritizes decentralized disease screening and community-based prevention.
Distribution & Accessibility Strategy
- Retail Rollout: Launch via JD Health, Alibaba Health, and 40,000+ pharmacy partners by Q2 2026
- Public Sector: Under discussion for inclusion in China CDC’s national HIV screening programs and World AIDS Day campaigns
- Export Pathway: Clinical data package being prepared for WHO prequalification to target Southeast Asian markets with similar HIV prevalence patterns
Competitive Landscape
- Domestic: Wantai is the first and only NMPA-approved oral HIV self-test; no direct competitors currently
- Global: OraSure’s OraQuick® holds WHO prequalification but lacks China regulatory approval; blood-based rapid tests dominate the local market
- Barrier to Entry: High regulatory hurdle for Class III IVDs and requirement for HIV‑2 validation data
Forward‑Looking Statements
This brief contains forward-looking projections regarding Wantai’s revenue, market penetration, and public health adoption. Actual results may differ based on pricing negotiations, competitive responses, and evolving national screening policies.-Fineline Info & Tech