By Fineline Cube 
Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for its novel adjuvanted recombinant shingles vaccine REC610 has been officially accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) (Acceptance No.: CXSS2500145), positioning it as the first potential competitor to GSK’s Shingrix in the world’s largest shingles vaccine market.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | REC610 (recombinant shingles vaccine) |
| Company | Jiangsu Recbio Technology (2179.HK) |
| Regulatory Status | NDA accepted by CDE/NMPA |
| Acceptance Number | CXSS2500145 |
| Submission Date | 29 Dec 2025 |
| Adjuvant | BFA01 (proprietary novel adjuvant) |
| Target Population | Adults ≥50 years for herpes zoster prevention |
Product Profile & Differentiation
Mechanism of Action: REC610 utilizes Recbio’s proprietary BFA01 adjuvant to stimulate high levels of VZV glycoprotein E (gE)‑specific CD4+ T cells and antibodies, mimicking the natural immune response more effectively than live‑attenuated vaccines.
Competitive Advantages:
- Cellular Immunity: Novel adjuvanted recombinant platform provides stronger CD4+ T cell responses vs. live vaccines
- Efficacy: Expected to match or exceed Shingrix’s >90% protective efficacy based on Phase 2 data
- Duration: Longer‑lasting protection (projected >7 years) vs. 4‑5 years for live vaccines
- Safety: Recombinant platform eliminates risk of vaccine‑derived viral replication
Market Opportunity: China’s Shingles Burden
Disease Epidemiology:
- Annual Incidence: ~6 million herpes zoster cases annually in China
- Trend: Increasing prevalence in younger populations (40‑49 age group growing at 12% CAGR)
- Vaccination Rate: <1% of eligible population (vs. >40% in US/EU)
- Addressable Market: 250 million adults ≥50 years; 400 million adults ≥40 years
Market Dynamics:
- Current Standard: Shingrix (GSK) launched in China in 2020; captured >95% market share
- Supply Constraints: Shingrix faces periodic shortages due to global demand and manufacturing limitations
- Pricing: Shingrix costs ¥1,598 per dose (2‑dose regimen); REC610 projected at ¥1,200‑1,400 per dose to drive adoption
Competitive Landscape
| Vaccine | Company | Technology | China Status | Efficacy (≥50 yrs) | Price/Dose (¥) |
|---|---|---|---|---|---|
| Shingrix | GSK | Adjuvanted recombinant (AS01B) | Marketed (2020) | >90% | 1,598 |
| REC610 | Recbio | Adjuvanted recombinant (BFA01) | NDA accepted | Phase 3 data pending | 1,200‑1,400 (projected) |
| Zostavax | Merck | Live attenuated | Withdrawn | ~51% | N/A |
| Others | Walvax, Zhifei | Live attenuated (pipeline) | Phase 3 | ~50‑60% | 500‑800 (projected) |
Market Entry Strategy: REC610 aims to capture 15‑20% market share by 2028 via domestic production advantage and competitive pricing.
Financial Projections
| Revenue Scenario | 2027E | 2028E | 2029E |
|---|---|---|---|
| China shingles vaccine market (¥B) | 8.5 | 12.0 | 16.5 |
| REC610 market share | 2% | 8% | 15% |
| Doses sold (million) | 0.5 | 1.9 | 3.8 |
| Net revenue (¥ million) | 600 | 2,280 | 4,560 |
| Royalty to GSK (if applicable) | None | None | None |
| Gross margin | 85% | 87% | 88% |
Peak Sales Potential: ¥5‑6 billion (US$700‑840 M) by 2030 if NRDL inclusion achieved.
Production & Commercialization
Manufacturing: Recbio’s Changshu facility (capacity: 20 million doses/year by 2026) will produce REC610; dedicated shingles vaccine line operational Q1 2026.
Commercialization: Self‑commercialization via established vaccine sales team covering 2,000+ CDCs and 10,000+ vaccination clinics; partnership discussions with E‑pharmacy platforms (JD Health, Ali Health) for direct‑to‑consumer channels.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding REC610’s regulatory approval timeline, market penetration, pricing strategy, and peak sales forecasts. Actual results may differ materially due to NMPA review outcomes, competitive responses from GSK, market adoption rates, and potential NRDL pricing pressures.-Fineline Info & Tech