FDA.reportPublic FDA data

Application 761258

Type
BLA
Sponsor
AKESO BIOPHARMA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761258penpulimab-kcqx351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENPULIMAB-KCQXPENPULIMAB-KCQXINJECTABLE;INTRAVENOUS100MG/10ML(10MG/ML)NoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penpulimab kcqxPENPULIMABAkeso Biopharma, Co., Ltd830004e8-31af-4cc6-ab16-e870cab1c5ca2025-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761258

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82213ORIG 2025-05-21
82095ORIG 2025-05-01
81966ORIG 2025-04-24