Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted

Recently, CGeneTech (Suzhou) Co., Ltd. (CGeneTech) submitted the DPP-4 inhibitor Sitagliptin, for the treatment of type 2 diabetes, to the National Medical Products Administration (NMPA) for approval.

Medicilon helped CGeneTech submit the DPP-4 inhibitor Sitagliptin.webp

Shanghai Medicilon Inc. (Medicilon), as a partner of CGeneTech, provided Sitagliptin with comprehensive preclinical research services in compliance with GLP regulations, including pharmacodynamic research, pharmacokinetic research and safety evaluation, as well as Phase I clinical bioanalysis to facilitate its efficient and high-quality R&D.

Medicilon Preclinical Research Platform

Help drug research and development faster, better and cost-efficient

Efficiency comes from collaboration, and success comes from experience. Medicilon, as a one-stop comprehensive preclinical research and development service CRO for biopharmaceutical, has been continuously improving the scientific and technological innovation for 19 years, providing customized preclinical test service solutions for various drugs, and have accumulated rich R&D experience in drug metabolism, pharmacokinetics, pharmacodynamics research, and toxicology. With high-quality data and fast turnaround time, Medicilon preclinical research platform could help clients to develop their drugs faster, better and with less cost.

As early as 2009, the preclinical research laboratory of Medicilon's wholly-owned subsidiary, Medicilon Preclinical Research (Shanghai) LLC, obtained the certification of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and reached the GLP standard of both US FDA and China’s NMPA, as well as the preclinical safety evaluation with the GLP specification of the Organization for European Economic Cooperation and Development (OECD).

此博客中的热门博文

Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

阅读全文

In Vitro Enzyme Activity Assay

Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+ in vitro enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...

阅读全文

Pharmacokinetics Services

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an...

阅读全文

Shanghai Medicilon Inc.

搜索此博客