FDA — authorised 23 April 2025
- Application: BLA761258
- Marketing authorisation holder: AKESO BIOPHARMA
- Local brand name: PENPULIMAB-KCQX
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 PENPULIMAB-KCQX in United States
FDA authorised PENPULIMAB-KCQX on 23 April 2025
Marketing authorisations
FDA
- Status: approved
PENPULIMAB-KCQX in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is PENPULIMAB-KCQX approved in United States?
Yes. FDA authorised it on 23 April 2025; FDA has authorised it.
Who is the marketing authorisation holder for PENPULIMAB-KCQX in United States?
AKESO BIOPHARMA holds the US marketing authorisation.