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 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 - Aug 4, 2026approval NMPA granted marketing approval for the rabies vaccine for human use (PVRV-SF) in China on August 4, 2026.
The rabies vaccine for human use (PVRV-SF) received marketing approval from the National Medical Products Administration (NMPA) in August 2026.
Filing - Jul 10, 2026accepted The bivalent enterovirus vaccine NDA was formally accepted for review by the CDE of NMPA on July 10, 2026, with priority review designation.
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
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
- GSK plc GSK
- Vaxcyte, Inc. PCVX
- Valneva SE VALN
- Kamada Ltd KMDA
- CorMedix Inc. CRMD
- Atea Pharmaceuticals, Inc. AVIR
- SIGA Technologies, Inc. SIGA
- Invivyd, Inc. IVVD
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.