Drug Profile

Recombinant human serum albumin biosimilar - Protgen

Latest Information Update: 21 Oct 2025

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At a glance

Originator Protgen
Class Acute-phase proteins; Albumins; Plasma expanders; Recombinant fusion proteins; Recombinant proteins
Mechanism of Action Protein replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

13 Aug 2024 Phase-II/III clinical trials in Ascites in China (IV) (NCT06553456)
13 Aug 2024 Phase-II/III clinical trials in Liver cirrhosis in China (IV) (NCT06553456)
13 Aug 2024 Protgen plans a phase II/III trial of recombinant human serum albumin biosimilar for Cirrhotic ascites in China in August 2024 (IV) (NCT06553456)

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