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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What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential tox...

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d...

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Enzyme Activity Assay Service

Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various enzyme activity assays for kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a large category of bio-molecules that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modifi...

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