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CGeneTech's Class 1 innovative drug CGT-9475 has achieved dual application and approval in China and the US with the help of Medicilon's one-stop preclinical pharmaceutical R&D service platform

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On July 22, CGT-9475, a new generation of ALK inhibitor independently developed by CGeneTech (Suzhou, China) Co., Ltd. (CGeneTech), was approved by the US Food and Drug Administration (FDA) to enter the clinical trial.  The drug is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of lung cancer.  This is another achievement after the CGT-9475 was approved for clinical trials by China's National Medical Products Administration (NMPA) in June 2022.


ALK inhibitors have significant advantages in clinical application, but the use of ALK inhibitors will inevitably lead to secondary drug resistance and brain metastases.  The ALK inhibitor CGT-9475 under research by CGeneTech aims to overcome drug resistance and solve the problem of central nervous system metastasis, and conduct high-quality and differentiated development.

In preclinical studies, CGT-9475 can simultaneously inhibit ALK and RET in non-small cell lung cancer cell lines, and shows a good blood-brain barrier penetration effect, which will bring new hope to patients with NSCLC brain metastases.  Therefore, CGT-9475 is expected to be used for subsequent treatment after existing ALK inhibitor resistance.

Medicilon One-Stop R&D Platform

All-round Empowerment of New Drug R&D Acceleration

CGT-9475 is an innovative new drug developed by CGeneTech with high quality and differentiation.  Medicilon, which also focuses on innovation, was entrusted by CGeneTech to provide one-stop preclinical comprehensive R&D services for the development of CGT-9475.  Based on the principle of "complementary advantages and collaborative innovation", the two parties carried out all-round in-depth collaboration, and formulated a series of scientific and rigorous experimental protocols for the R&D of the drug.  Medicilon insists on paying equal attention to efficiency and quality.  While meeting technical and regulatory requirements, Medicilon actively coordinate R&D schedules to achieve seamless connection between every R&D stages.  In the end, under the coordination and collaboration of multiple departments of both parties, Medicilon completed a full set of preclinical research services, providing technical support for CGT-9475 to achieve dual-reporting and dual-approval between China and the United States.

The research and development of new drugs is a comprehensive and systematic project, which requires the collaboration of multiple research departments. Medicilon has established a one-stop preclinical research and development service platform, which covers the entire process of preclinical new drug research, including drug discovery, pharmaceutical research and preclinical research.  One-stop R&D platform, strong integration of advantageous resources and collaboration of cross-departmental, give a full play to the synergistic effect of 1+1>2 and accelerate the development of new drugs.  In addition to providing one-stop preclinical new drug R&D services, Medicilon can also customize services according to customer needs and provide specialized services for a certain link of preclinical research and development.

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