Congratulations to Gluetacs Therapeutics' new drug clinical research application for GT919, the first molecular glue degradation agent pipeline, approved by the FDA

Recently, Gluetacs Therapeutics (Gluetacs)'s first class 1 new drug, GT919 Capsules, a molecular glue degradation agent pipeline, was approved by the US Food and Drug Administration (FDA) to enter clinical trials. It is for the treatment of malignant hematological tumors.

The pipeline was previously approved by the National Medical Products Administration (NMPA) for clinical trials on December 20, 2022, and is currently undergoing Phase I clinical trials in China. This is the first product pipeline of Gluetacs that has been approved for clinical trials in both China and the United States, and it is another milestone in the globalization process of Gluetacs. For the research and development of GT919, Shanghai Medicilon Inc, (Medicilon) relied on its solid R&D strength to efficiently complete the drug discovery to clinical application for GT919, including drug discovery, pharmaceutical research, and preclinical research based on Medicilon's one-stop preclinical research services platform. This has been highly recognized by Gluetacs.

Medicilon's One-Stop Preclinical R&D Service Platform
Empowering new drug research and development with faster and more economical

The approval of new drugs is inseparable from the full collaboration of both parties. With the mutual trust and support of Medicilon and Gluetacs, Medicilon provided one-stop preclinical R&D services for GT919, helping to obtain clinical approval, which demonstrated the R&D innovation strength of innovative pharmaceutical companies. It also once again reflects the capabilities and advantages of Medicilon's one-stop biopharmaceutical preclinical R&D service platform.

Relying on the technological advantages and R&D platform advantages accumulated over the past 19 years, Medicilon has continuously expanded the upstream and downstream areas of the industrial chain around the needs of new drug R&D, and successfully created a comprehensive and integrated preclinical CRO service model. Not only can the research and development links be seamlessly connected in series, but also can be integrated into a parallel research and development model. Therefore, Medicilon presents the service advantages of strict planning, efficient coordination, and orderly advancement, which can empower new drug research and development in faster, better, and less costly ways.

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