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.

▲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.