Shenzhen Protgen Announces Publication of Phase 3 Clinical Trial Results for Recombinant Human Serum Albumin (PG-rHSA) in STTT

Published Time:

2026-09-19 15:20


SHENZHEN, September 19, 2026 — Shenzhen Protgen Co., Ltd. ("Shenzhen Protgen") today announced that the Phase 3 clinical trial and molecular evaluation of its investigational Recombinant Human Serum Albumin (PG-rHSA) for the treatment of cirrhotic ascites have been published in Signal Transduction and Targeted Therapy (STTT).

Sponsored by Shenzhen Protgen, this nationwide, multicenter, randomized, double-blind, active-controlled Phase 3 study evaluated the clinical performance of PG-rHSA relative to plasma-derived human serum albumin (pHSA) in patients with cirrhotic ascites and hypoalbuminemia.

Key findings include:

  1. Primary Endpoint: PG-rHSA demonstrated statistical equivalence to pHSA in raising serum albumin levels.
  2. Secondary Endpoint: PG-rHSA achieved non-inferiority in ascites improvement rate relative to the control group.
  3. Safety: The overall incidence of adverse events was comparable between arms, with no drug-related immunogenicity signals observed.

The New Drug Application (NDA) for PG-rHSA has been officially accepted by the CDE of the National Medical Products Administration (NMPA), and is currently undergoing formal regulatory review.

 

Article DOI: 10.1038/s41392-026-02951-7

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