Medicilon assists the world's first, Leado Pharma's IBD treatment FIC new drug IND application approved by the US FDA

On May 11, Leado Pharma (Leado) announced that the company's independently developed First-in-class new drug LD09163 tablets for treating inflammatory bowel disease has obtained IND approval from the US FDA and officially entered the clinical development stage. This milestone breakthrough not only demonstrates the R&D strength of Leado, but also signifies its formal move towards internationalization

Shanghai Medicilon Inc. (Medicilon), as a partner of Leado Pharma, relies on its one-stop biopharmaceutical preclinical research and development service platform to provide pharmaceutical research (including API and formulations), preclinical research (including pharmacokinetics and safety assessment), as well as one-stop development services such as IND filing application for LD09163 tablets, assisting in smooth clinical approval and accelerating the research and development process.

Leado Pharma's IBD treatment FIC new drug IND application approved by the US FDA.webp

▲FDA Approval Document

In the fierce competition of new drug development, speed and quality are crucial. With twenty years of deep cultivation in the preclinical research field, Medicilon, leveraging its profound understanding of the industry and rich experience, has successfully established a 'one-stop biopharmaceutical preclinical research and development service platform'. The platform comprehensively covers the complete chain from drug discovery, pharmaceutical research to preclinical research, providing comprehensive support for new drug research and development.

Medicilon relies on its rigorous project management strategy to ensure the steady progress of each R&D project and improve overall R&D efficiency. Meanwhile, leveraging an efficient collaborative team mechanism, Medicilon has successfully achieved seamless integration between different stages of research and development, injecting powerful and sustained momentum into new drug development. In addition, through meticulous optimization of resource allocation and process management, Medicilon ensures high quality throughout the research and development process, providing clients with one-stop, reliable, and efficient development services.

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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

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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...

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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...

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