Medicilon assists Chipscreen Biosciences' CS12192 to be approved by the FDA

On August 28, 2021, the FDA recently approved the CS12192, a new drug clinical trial application for the treatment of Graft Versus Host Disease (GVHD) independently developed by Chipscreen Biosciences (Chipscreen).  Previously, the drug has obtained clinical approval in China.

It is worth mentioning that Shanghai Medicilon Inc. (Medicilon) provides comprehensive preclinical research including pharmacokinetics and safety evaluation on the development of CS12192.  With the 17 years of research and development experience, Medicilon provides with economy, high quality and high efficiency, to help the partner, Chipscreen, to successfully develop the drug.

The completed preclinical studies have shown that CS12192 has strong pharmacodynamic activity in autoimmune disease models such as rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, psoriasis, and GVHD. In some disease models, it shows differentiated pharmacodynamic characteristics that are different from other JAK kinases.  Compared with the JAK kinase inhibitors already on the market, CS12192 can not only effectively inhibit the inflammation mediated by excessive activation of immune cells, but also reduce the tissue invasion of immune cells by inhibiting TBK1, which is expected to provide a new clinical treatment option for autoimmune-related diseases.

CS12192 is a highly selective JAK3 kinase inhibitor and also partially inhibits JAK1 and TBK1 kinases that has been independently developed by Chipscreen and has been authorized by the global compound invention patent.  In addition, there is no such inhibitor drug on the market at this moment.  In order to successfully carry out the research and development of CS12192, the team of Medicilon strived to ensure the successful completion of the project with rich FDA application experience, complied with the international GLP standard and successfully completed the SEND format conversion of the data.  This not only proves the R&D strength of Medicilon, but also shows that Medicilon’s R&D quality management system and project management system have entered a mature and experienced stage.

Medicilon congratulates Chipscreen’s CS12192 on its FDA approval and its initial success. Next, Medicilon will deliver more excellent results to help the clients successfully complete the advancement of various projects.

About Chipscreen Biosciences

Chipscreen Biosciences is a pioneer in the field of China’s original innovative drugs founded in March 2001 by a team of experienced Ph.Ds returning from the US.  The company adheres to the concept of “original, efficiency, safety, and China”, focusing on the research and development of innovative drugs in five major areas such as malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases and anti-viruses that pose a serious threat to human life and health.  Chipscreen committed to providing patients with affordable, clinically urgently needed, innovative mechanism drugs with revolutionary curative effects.  Chipscreen is the first company on the Shanghai Sci-Tech innovation board and the first listed biomedical company (Stock Code 688321.SH).

About Medicilon

Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China.  Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research.  Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support.  Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally.  Medicilon is proud to contribute to human health in the globe.