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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG/10ML (10MG/ML)
Single-Dose Vial
351(a)
Rx
Proper Name
penpulimab-kcqx
BLA Number
761258
Applicant
Akeso Biopharma Co., Ltd.
Original Approval Date
April 23, 2025
Date of First Licensure
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