Purple Book reference family · 351(a) biologic
penpulimab-kcqx
penpulimab-kcqx is an FDA-licensed reference biologic from Akeso Biopharma Co., Ltd..
351(a) biologicBLA 761258 Akeso Biopharma Co., Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761258
Not listed penpulimab-kcqx
Akeso Biopharma Co., Ltd.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference penpulimab-kcqx product.
1 yr 3 mo ago
penpulimab-kcqx: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for penpulimab-kcqx.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
