Sinovac Biotech Ltd SVA
Sinovac Biotech Ltd (Nasdaq: SVA) is an infectious disease drug developer. Its lead program, Bivalent enterovirus vaccine (HFMD2), is in Phase 3 for hand, foot and mouth disease (EV71/CA16). Its next catalyst on record is PVRV-SF: WHO prequalification application submission (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: PVRV-SF — WHO prequalification application submission (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| HFMD2 bivalent enterovirus vaccine (China NDA under NMPA priority review) | hand, foot and mouth disease | vaccine | Phase 3 |
| PCV13 13-valent pneumococcal conjugate vaccine | pneumococcal disease | vaccine | Phase 3 |
| HFMD4 quadrivalent enterovirus vaccine | hand, foot and mouth disease | vaccine | Phase 3 |
| MCV4 group ACYW135 meningococcal conjugate vaccine | meningococcal disease | vaccine | Phase 3 |
| HmAb-TT fully human anti-tetanus toxin monoclonal antibody | emergency prophylaxis of tetanus | antibody | Phase 3 |
| PVRV-SF serum-free rabies vaccine (NMPA-approved 2026-08-04; international Phase III ongoing; WHO PQ planned) | rabies | vaccine | Phase 3 |
| mRNA vaccine candidates (two) | unspecified | vaccine | Phase 1 |
Recent results and decisions
- Aug 17, 2026approval China NMPA approved the serum-free rabies vaccine PVRV-SF on August 4, 2026 (ex-US regulatory action); WHO prequalification application planned.
The vaccine received marketing approval from NMPA on August 4, 2026.
Filing - Aug 17, 2026accepted China NMPA CDE accepted the HFMD2 marketing authorization application for review on July 10, 2026 with priority review designation (ex-US).
The marketing authorization application was formally accepted for review by the Center for Drug Evaluation (CDE) of NMPA on July 10, 2026, and was granted priority review designation.
Filing - Aug 4, 2026approval Rabies vaccine for human use (PVRV-SF) received marketing approval from the National Medical Products Administration (NMPA) in August 2026.
The rabies vaccine for human use (PVRV-SF) received marketing approval from the National Medical Products Administration (NMPA) in August 2026.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- Gilead Sciences, Inc. GILD
- GSK plc GSK
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- CorMedix Inc. CRMD
- Valneva SE VALN
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.