TGA / PMDA / NMPA · Asia-Pacific
enterovirus — TGA / PMDA / NMPA regulatory status
enterovirus regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: NMPA clinical trials.
Status snapshot
- Status
- NMPA clinical trials
- Structured fields
- 4
Regional decision snapshot — NMPA: clinical trials.
Linked evidence on this spoke: 7 published clinical programs and 5 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| NMPA | China | clinical trials | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| PRO-EV71CA16-3001 | Phase 3 | Sinovac Research and | NCT06734832 |
| 100U EV71 vaccine with adjuvant | Phase 2 | Sinovac Research and | NCT01421121 |
| 400 U EV71 vaccine with adjuvant | Phase 2 | Sinovac Research and | NCT01812135 |
| Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell) | Phase 2 | Sinovac Research and | NCT06754384 |
| PRO-EV71/CA16-1001 | Phase 2 | Sinovac Research and | NCT06063057 |
| 100U inactivated Enterovirus Type 71 Vaccine | Phase 1 | Sinovac Research and | NCT01273246 |
| Inactivated Enterovirus Type 71 Vaccine | Phase 1 | Sinovac Research and | NCT01273233 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11834451 | Compositions and methods for inhibiting virus protein 2C activity and for preventing and treating non-polio enterovirus infection | US |
| 10555997 | Antigens and vaccines directed against human enteroviruses | US |
| 10548964 | Antigens and vaccines directed against human enteroviruses | US |
| 9987350 | Antigens and vaccines directed against human enteroviruses | US |
| 8524676 | Method for treating enterovirus or rhinovirus infection using antisense antiviral compounds | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of enterovirus?
enterovirus currently shows NMPA clinical trials in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get enterovirus regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to enterovirus?
This spoke lists 7 published programs associated with enterovirus in our pipeline index.