Pegybio gains expanded approval for chronic hepatitis B indication

Xiamen Amoytop Biotech Co., Ltd. announced that its flagship product, Pegybio (polyethylene glycol interferon a-2b injection), has received approval from the National Medical Products Administration for an expanded indication. The new approval permits Pegybio, in combination with nucleos(t)ide analogues, for the sustained clearance of HBsAg in adults with chronic hepatitis B. This applies to patients who are nucleos(t)ide-treated, have HBsAg below 1500 IU/mL, sustained virological suppression, and HBeAg negative or HBeAg 10 COI below.

This approval is based on clinical trial results showing that Pegybio, combined with nucleos(t)ide analogues, achieved HBsAg seroconversion and sustained HBV DNA suppression in 31.4% of patients 24 weeks after stopping all treatment. This makes Pegybio the first approved drug for this indication, providing foundational therapy for clinical cure in chronic hepatitis B.

Pegybio, a Class 1 new biological drug in China, was initially approved in October 2016 for chronic hepatitis C and in September 2017 for chronic hepatitis B. The company expects this expanded indication to enhance Pegybio's market competitiveness and positively impact its business development.