TGA / PMDA / NMPA · Asia-Pacific
subcutaneous — TGA / PMDA / NMPA regulatory status
subcutaneous 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: 86 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 |
|---|---|---|---|
| 206785 | Phase 3 | GSK Glaxo Smith | 2023-510230-84-00 |
| 221672 | Phase 3 | GSK Glaxo Smith | 2024-513018-36-00 |
| 80202135SJS3001 | Phase 3 | Janssen-Cilag International N.V | 2024-513965-38-01 |
| 80202135SLE3001 | Phase 3 | Janssen-Cilag International N.V | 2025-523552-31-00 |
| CA209-67T | Phase 3 | Bristol-Myers Squibb Australia | 2023-503280-42-00 |
| D3252C00002 | Phase 3 | AstraZeneca | 2023-507987-38-00 |
| D3253C00001 | Phase 3 | AstraZeneca | 2023-510248-19-00 |
| D3254C00001 | Phase 3 | AstraZeneca | 2023-510455-28-00 |
| DCR-PHXC-301 | Phase 3 | Anaxis Pharma | 2024-512260-54-00 |
| Darleukin, Fibromun | Phase 3 | Philogen | 2024-515749-40-00 |
| HS-19-647 | Phase 3 | Currus Biologics Pty | 2024-510667-33-00 |
| HS-19-657 | Phase 3 | Currus Biologics Pty | 2023-508723-12-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12371506 | Subcutaneous administration of anti-CD38 antibodies | US |
| 12076397 | Emulsion adjuvant for intramuscular, intradermal and subcutaneous administration | US |
| 11944618 | Subcutaneous delivery of polymer conjugates of therapeutic agents | US |
| 11779635 | Subcutaneous administration of ADAMTS13 | US |
| 11491212 | Subcutaneous administration of modified factor IX polypeptides and treatment of hemophilia B | US |
| 11298350 | Subcutaneous delivery of polymer conjugates of therapeutics agents | US |
| 11266724 | Modified factor VII polypeptides for subcutaneous administration and on-demand treatment | US |
| 11242380 | Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use | US |
| 11224595 | Subcutaneous delivery of poly(oxazoline) polymer conjugates | US |
| 11213524 | Pharmaceutical compositions for subcutaneous administration of levosimendan | US |
| 11185575 | Subcutaneous administration of ADAMTS13 | US |
| 11129940 | Syringes, kits, and methods for intracutaneous and/or subcutaneous injection of pastes | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of subcutaneous?
subcutaneous 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 subcutaneous 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 subcutaneous?
This spoke lists 86 published programs associated with subcutaneous in our pipeline index.