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.

此博客中的热门博文

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 toxicity of the compou

阅读全文

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

阅读全文

Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

阅读全文

Shanghai Medicilon Inc.

搜索此博客