TGA / PMDA / NMPA · Asia-Pacific
therapy — TGA / PMDA / NMPA regulatory status
therapy 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: 523 published clinical programs and 12 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 |
|---|---|---|---|
| 10-week smoking cessation group therapy combined with NicoDerm CQ | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00110630 |
| 2 cycles induction chemotherapy | Phase 3 | First People's Hospital | NCT05860868 |
| 2008-46 | Phase 3 | First People's Hospital | NCT00643877 |
| 20170770 | Phase 3 | Amgen | 2023-507149-27-00 |
| 20230127 | Phase 3 | Amgen | 2023-508359-38-00 |
| 217102 | Phase 3 | GSK Glaxo Smith | 2023-510019-20-00 |
| 2215-CL-0201 | Phase 3 | Astellas Pharma | 2024-512474-98-00 |
| 3-dimensional conformal radiation therapy | Phase 3 | United Therapeutics Europe | NCT01216800 |
| ADAURA - D5164C00001 | Phase 3 | AstraZeneca | 2023-506524-82-00 |
| APF530 | Phase 3 | Heron Therapeutics | NCT02106494 |
| APHP180596 | Phase 3 | PARItec | 2024-516849-39-01 |
| APHP200026 | Phase 3 | PARItec | 2024-516687-28-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12420113 | Methods and apparatus for applying tumor treating fields combined with personalized ultra-fractionated stereotactic adaptive radiotherapy | US |
| 12414983 | CD200AR ligands for cancer immunotherapy | US |
| 12404318 | Combination HBV therapy | US |
| 12397028 | Adoptive cellular therapy | US |
| 12397066 | Delivery of gene therapy treatments | US |
| 12384830 | Compositions and methods for improving immunotherapy | US |
| 12385010 | Gene therapy for recessive dystrophic epidermolysis bullosa using genetically corrected autologous keratinocytes | US |
| 12377093 | Pyruvate kinase activators for use in therapy | US |
| 120418289 | Combination therapy of bispecific binding agents that bind to CLDN18.2 and CD3 with immune checkpoint inhibitors | CN |
| 12370206 | Therapy for inhibition of single-stranded RNA virus replication | US |
| 12364775 | Viral vectors for cancer therapy | US |
| 12364774 | Nucleic acid molecules and uses thereof for non-viral gene therapy | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of therapy?
therapy 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 therapy 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 therapy?
This spoke lists 523 published programs associated with therapy in our pipeline index.