Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted

Recently, CGeneTech (Suzhou) Co., Ltd. (CGeneTech) submitted the DPP-4 inhibitor Sitagliptin, for the treatment of type 2 diabetes, to the National Medical Products Administration (NMPA) for approval.

Medicilon helped CGeneTech submit the DPP-4 inhibitor Sitagliptin.webp

Shanghai Medicilon Inc. (Medicilon), as a partner of CGeneTech, provided Sitagliptin with comprehensive preclinical research services in compliance with GLP regulations, including pharmacodynamic research, pharmacokinetic research and safety evaluation, as well as Phase I clinical bioanalysis to facilitate its efficient and high-quality R&D.

Medicilon Preclinical Research Platform

Help drug research and development faster, better and cost-efficient

Efficiency comes from collaboration, and success comes from experience. Medicilon, as a one-stop comprehensive preclinical research and development service CRO for biopharmaceutical, has been continuously improving the scientific and technological innovation for 19 years, providing customized preclinical test service solutions for various drugs, and have accumulated rich R&D experience in drug metabolism, pharmacokinetics, pharmacodynamics research, and toxicology. With high-quality data and fast turnaround time, Medicilon preclinical research platform could help clients to develop their drugs faster, better and with less cost.

As early as 2009, the preclinical research laboratory of Medicilon's wholly-owned subsidiary, Medicilon Preclinical Research (Shanghai) LLC, obtained the certification of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and reached the GLP standard of both US FDA and China’s NMPA, as well as the preclinical safety evaluation with the GLP specification of the Organization for European Economic Cooperation and Development (OECD).

此博客中的热门博文

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 ...

阅读全文

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...

阅读全文

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...

阅读全文

Shanghai Medicilon Inc.

搜索此博客