Fujian Cosunter Pharmaceutical(300436.SZ): The innovative hepatitis B treatment drug surface antigen inhibitor GST-HG131 has achieved significantly better positive therapeutic effects compared to placebo controls.

Intelligence Financial APP News, Fujian Cosunter Pharmaceutical (300436.SZ) announced that the company's oral surface antigen inhibitor GST-HG131 for the treatment of hepatitis B has completed the Phase IIa clinical trial of chronic hepatitis B (CHB) in the first group of studies. The first group of data was recently unblinded and obtained a phase research report, showing that GST-HG131 achieved significantly better positive therapeutic effects compared to the placebo control, in line with the research expectations. The study was led by Major General Wang Fusheng from the Fifth Medical Center of the People's Liberation Army (formerly the 302nd Hospital of the PLA) as the principal investigator (PI), with Hangzhou Tigermed Consulting Technology Co., Ltd. serving as the clinical CRO. The results of the study showed that in the first group (30mg, oral administration twice daily for 28 days), GST-HG131 significantly reduced the serum surface antigen (HBsAg) levels in patients with chronic hepatitis B, with a maximum decrease of 1.07 log10IU/ml, while demonstrating good safety and tolerability. The company will continue to enroll the remaining two groups of subjects in the Phase IIa clinical study, and the relevant research data from the first group will be submitted to the National Medical Products Administration for early communication on the follow-up clinical development plan. GST-HG131 is a novel oral small molecule surface antigen inhibitor that targets the intracellular PAPD5/7, thereby reducing the intracellular synthesis and secretion of virus surface antigens by inhibiting the stability of hepatitis B virus messenger ribonucleic acid (mRNA). Currently, there are no similar products on the market globally, making GST-HG31 the leading project in global development targeting this mechanism and target. The company initiated the development of GST-HG131 in 2016, and after 8 years, with guidance from numerous domestic and foreign experts, it has become the first approved oral surface antigen inhibitor to enter clinical development in China and the first to enter Phase II clinical trials globally. Surface antigen HBsAg clearance is a key clinical endpoint recognized in the industry for the clinical cure of hepatitis B. In the Phase IIa clinical study, the first group data showed varying degrees of decrease in HBsAg levels in all subjects in the treatment group, demonstrating significant efficacy and providing key support for the company's future promotion of the Triple Oral Therapy Summit Plan (GST-HG141+GST-HG131+nucleos(t)ide analogs).