Medicilon Logo
|
search icon search icon language icon contact icon menu icon
Medicilon Logo
|
search icon close search icon language icon contact icon menu icon
logo icon CN
Contact Us
Close Button
Message
Back To Top
Online Message×
Click switch
Close Button
Medicilon's News information
News information

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

2021-09-07
|
Page View:

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.

Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

CS12192
CS12192

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's preclinical pharmacology and toxicology research team is equipped with a professional send format conversion team, and has established a send data conversion platform that is fully mature in terms of software, technology, specification and quality, so as to realize accurate data conversion and provide a good environment for electronic data submission. In 2020 alone, it has helped customers complete 14 send data conversion projects, of which 3 new drug projects have obtained clinical licenses from FDA.

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.

Reference:
SEND Format Conversion Platform
Transformation of Medicilon's New Drug R&D Data in SEND Format to Help You Successfully Apply for FDA
Medicilon Assisted DAC Biotechnology's Fourth ADC Drug DXC007 Getting Approved for Clinical Use

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.

Return
Relevant newsRelevant news