Application 761258
- Type
- BLA
- Sponsor
- AKESO BIOPHARMA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761258 | penpulimab-kcqx | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENPULIMAB-KCQX | PENPULIMAB-KCQX | INJECTABLE;INTRAVENOUS | 100MG/10ML(10MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Penpulimab kcqx | PENPULIMAB | Akeso Biopharma, Co., Ltd | 830004e8-31af-4cc6-ab16-e870cab1c5ca | 2026-09-08 | Warnings, Adverse reactions | BLA761258 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.