🇺🇸 Penpulimab kcqx in United States

FDA authorised Penpulimab kcqx on 23 April 2025

Marketing authorisations

FDA — authorised 23 April 2025

  • Application: BLA761258
  • Marketing authorisation holder: AKESO BIOPHARMA
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Penpulimab kcqx, a new molecular entity, on 23 April 2025. This approval was granted to AKESO BIOPHARMA under the standard expedited pathway. The indication for Penpulimab kcqx is not specified in the provided information.

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FDA

  • Marketing authorisation holder: AKESO BIOPHARMA
  • 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 Oncology 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.