Recently, the pivotal Phase III clinical study of Progen's fully in-house developed Recombinant Human Serum Albumin (rHSA) Injection for the indication of cirrhosis-induced ascites successfully met the primary efficacy endpoint and key secondary efficacy endpoints required by the National Medical Products Administration (NMPA). The New Drug Application (NDA) for market approval has been fully initiated.

The Phase III clinical study of Progen's Recombinant Human Serum Albumin Injection for the cirrhosis-induced ascites indication adopted a multi-center, randomized, double-blind, active-controlled, parallel-group design. The primary efficacy endpoint was the change in serum albumin concentration (ALB) from baseline following treatment completion, used to verify the equivalence between rHSA and plasma-derived human serum albumin (pHSA) in patients with cirrhosis-induced ascites. The key secondary efficacy endpoint was the ascites improvement rate after treatment completion, compared for non-inferiority, to assess the clinical benefit of albumin supplementation in subjects.

Progen's Recombinant Human Serum Albumin Injection Achieves Key Progress in Phase III Study | Efung Investment Update

The trial results demonstrated that rHSA significantly increased ALB levels in patients with cirrhosis-induced ascites, showing equivalence to pHSA, and achieved a notable improvement in ascites. Safety data indicated that rHSA has a favorable safety and tolerability profile, with all immunogenicity results in the rHSA group being negative, demonstrating extremely low immunogenicity.