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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The Launch Meeting was Held by Medicilon and DAC Biotech of the Contract Research on ADC Preclinical Study

Chuansha, Shanghai, Nov. 8th, 2019 — Medicilon held the launch meeting with Hangzhou DAC Biotech Co., Ltd to initiate the preclinical study of the antibody-drug-conjugate (ADC) DXC005, including the pharmacology study , DMPK study and the safety evaluation . Medicilon has previously completed integrated preclinical research on ADC drugs cooperating with DAC Biotech and other companies. Two of them has been approved by NMPA and entered Phase I clinical trials. About Hangzhou DAC Biotech Co., Ltd Hangzhou DAC Biotech, Co., Ltd was officially registered in HEDA Area, Hangzhou City, Zhejiang Province, China around the end of Year 2012, and is located nearby the bank of beautiful Qiantang River. The company focuses on developing conjugate of monoclonal antibody and small molecular cytotoxic drug, both of which are banded together with smart linkers. About Antibody-Drug-Conjugate (ADC) ADCs ...

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Medicilon assisted Hangzhou DAC Biotech in approval of clinical study of ADC drug DAC-002

On July 20, 2020, DAC Biotech’s new ADC drug development , TROP2-ADC—DAC-002 was approved of clinical study by NMPA. for the indication of solid malignant tumor. Medicilon completed preclinical pharmacokinetic and toxicological studies in this project, accelerating the development process. DAC-002 is an ADC anti-Trop2 monoclonal antibody conjugated by an intelligent ligand against Tubulysin B analogue. It is used to treat Trop2 triple negative breast cancer, small cell lung cancer, non-small cell lung cancer and pancreatic cancer.Trop2 can promote the proliferation, invasion, metastasis and diffusion of tumor cells, and its high expression is closely related to the shortening of survival time and poor prognosis of tumor patients. Therefore, it is of great significance to study anti-tumor drugs targeted by Trop2. Reference: Medicilon Assists - The first China-made targeting folic acid receptor FRα ADC injection BAT8006 was approved for clinical use Medicilon As...

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Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration. The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies, ADCs , mRNA vaccines , small nucleic acid drugs , PROTAC , and CGT technical service platform that have helped 421 INDs obtain clinical approval. It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...

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