Guizhou Bailing hepatitis B new drug "tifentai" research and development has made new progress

On the evening of December 20, Guizhou Bailing issued an announcement on the research progress of the "Thifentai" project, and the company commissioned Shanghai WuXi AppTec New Drug Development Co., Ltd. to carry out the "in vitro anti-HBV efficacy test using primary human hepatocytes (PHH) to evaluate the subject compound (terifectaide)" successfully completed. The study used different models to once again prove that the new chemical drug "tifentax", a new chemical drug class 1.1 used for the treatment of hepatitis B, has a strong inhibitory effect on hepatitis B surface antigen, e antigen and HBV-DNA.

"Tifentai" is a phenylalanine dipeptide derivative synthesized from the basic skeleton of the Miao folk herb "horseshoe golden herb", which is the core representative variety of Guizhou Lark's implementation of "scientific and technological seedlings", and is the first class 1.1 new drug in Guizhou Province since the founding of the People's Republic of China, which has been authorized by the United States patent, and has successively obtained the rolling support of the national "Twelfth Five-Year Plan" major new drug creation and Guizhou Province's major scientific and technological projects. Since Professor Liang Guangyi, Key Laboratory of Natural Product Chemistry of Guizhou Academy of Sciences, discovered the peptide compound "Horseshoe Gold" with strong anti-hepatitis B virus activity, Guizhou Bailing cooperated with Academician Liu Changxiao of Tianjin Pharmaceutical Research Institute and Professor Huang Zhengming of the 302nd Hospital of the Chinese People's Liberation Army to complete preclinical research. From 2014 to 2016, a Phase I clinical trial study was carried out in the First Affiliated Hospital of Soochow University, and the results showed that the safety treatment window of Tiffentec was large, the target organ was the liver, the metabolic process was clear, and it was in line with the expectations of liver disease treatment drugs.

Since the completion of phase I clinical trials, combined with the communication opinions and research needs of CDE, 14C marker material balance, metabolite activity and other related studies have been carried out successively. This study is a study carried out by Guizhou Lark on the basis of years of in-depth research on "tifentai" to further explore the possibility of functional cure of hepatitis B in tifentai tablets. The results showed that "tiffantide" showed strong inhibitory effect on HBsAg, HBeAg (e antigen) and HBV-DNA.

Industry insiders pointed out that once the above-mentioned efficacy of "Tifentai" is verified in future human trials, it will have an epoch-making effect on the functional cure of hepatitis B. With the conclusion of this study, the research and development process of the "Tifentai" project will be further accelerated. (Gao Yi)