Fujian Cosunter Pharmaceutical (300436.SZ): Innovative hepatitis B treatment drug Nairucowe GST-HG141 has obtained ethical approval for Phase III clinical trials.

Fujian Cosunter Pharmaceutical (300436.SZ) announced that its innovative drug holding subsidiary Fujian Guangsheng Zhonglin Biological Technology Co., Ltd. (referred to as "Guangsheng Zhonglin") recently obtained the ethical approval document for the randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial of "GST-HG141 for the combination therapy of chronic hepatitis B (CHB) patients with poor response to antiviral drugs (add-on)" issued by the Ethics Committee of Shulan (Hangzhou) Hospital. This marks the approval of the Phase III clinical trial plan of GST-HG141 by the leading unit, which will be led by academician Li Lanjuan of Shulan (Hangzhou) Hospital as the principal investigator (PI). The company will continue to actively promote the ethical review of the leading unit Beijing University-First Hospital (with Professor Wang Guiqiang as PI) and other research centers, and organize clinical research. The announcement shows that Nairukewe GST-HG141 is a new type of hepatitis B core protein/capsid regulator, belonging to a new class of investigational anti-hepatitis B virus drugs with a novel mechanism. The company owns its global independent intellectual property rights. The results of Phase Ib and II clinical trials show that GST-HG141 tablets have significant efficacy and good safety, act quickly, and have a further significant inhibitory effect on HBV DNA on top of nucleoside drug therapy, and significantly reduce HBV pgRNA, indirectly indicating a potential effective inhibition and depletion of HBV cccDNA. Therefore, it may become a cornerstone drug, reconstructing the defense line against hepatitis B.