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On October 26, 2022, the clinical trial application (IND) of the new class I drug CS0159 oral tablet for the indication of primary biliary cholangitis (PBC) was approved
by the National Medical Products Administration.
CS0159 IND for primary sclerosing cholangitis (PSC) was approved
by the National Medical Products Administration on January 25 this year.
by the National Medical Products Administration.
CS0159 IND for primary sclerosing cholangitis (PSC) was approved
by the National Medical Products Administration on January 25 this year.
CS0159 is a new potent non-steroidal farnesyl X receptor (FXR) small molecule agonist obtained based on crystal structure-assisted design, which was jointly developed by Xu Huaqiang's research group and Li Jia's research group of Shanghai Institute of Materia Medica.
In 2020, it was transformed into Kaiscadi (Shanghai) Pharmaceutical Technology Co.
, Ltd.
by exclusive license by Shanghai Institute of Materia Medica, and Van Andel Research Institute in the United States for global R&D and promotion
.
In 2020, it was transformed into Kaiscadi (Shanghai) Pharmaceutical Technology Co.
, Ltd.
by exclusive license by Shanghai Institute of Materia Medica, and Van Andel Research Institute in the United States for global R&D and promotion
.
CS0159 new indication IND approved in China
Xu Huaqiang's team at Shanghai Institute of Materia Medica, has been in-depth research in the field of the mechanism of action of nuclear hormone receptor drugs for more than 20 years; Li Jia's team has long been committed to the research and development of innovative drugs for metabolic diseases, and has established a multi-target integration, multi-functional screening and multi-level pharmacodynamic evaluation system
around metabolic diseases such as diabetes and non-alcoholic steatohepatitis.
Based on a deep understanding of the structure and mechanism of FXR target and drug interaction, the research team designed and synthesized a series of lead compounds, and systematically evaluated the efficacy, toxicology and pharmacokinetics of the compounds in vivo and in vivo, and finally obtained the new drug candidate CS0159
.
The innovation of this project is to make full use of protein structure-assisted design to discover sites that can enhance drug activity and reduce drug side effects, and apply them to the molecular design of
new drugs.
around metabolic diseases such as diabetes and non-alcoholic steatohepatitis.
Based on a deep understanding of the structure and mechanism of FXR target and drug interaction, the research team designed and synthesized a series of lead compounds, and systematically evaluated the efficacy, toxicology and pharmacokinetics of the compounds in vivo and in vivo, and finally obtained the new drug candidate CS0159
.
The innovation of this project is to make full use of protein structure-assisted design to discover sites that can enhance drug activity and reduce drug side effects, and apply them to the molecular design of
new drugs.
Systematic preclinical studies have shown that CS0159 has the characteristics of potent FXR agonist activity and liver targeting distribution, can significantly improve the serological and pathological conditions of mouse PBC models, has the characteristics of low onset dose, significant efficacy and good tolerability, and its clinical trial approval is expected to provide safe and effective potential treatment options
for PBC patients.
for PBC patients.
The research and development of CS0159 has also been strongly supported
by Mei Xuefeng, researcher of the Center for Drug Quality Control and Solid State Chemistry, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, researcher Chen Xiaoyan and Diao Xingxing of the Center for Drug Metabolism, and researcher Gao Zhaobing of the Center for Neuropsychiatric Diseases.
by Mei Xuefeng, researcher of the Center for Drug Quality Control and Solid State Chemistry, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, researcher Chen Xiaoyan and Diao Xingxing of the Center for Drug Metabolism, and researcher Gao Zhaobing of the Center for Neuropsychiatric Diseases.
(Contributing department: Xu Huaqiang research group, Li Jia research group)
