Today, the new generation ALK inhibitor CGT-9475 independently developed by CGeneTech has been approved by the US Food and Drug Administration (FDA) for clinical trials. This 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 new drug project approved by CGeneTech after the CXCR4 antagonist cgt-1881 was approved in China and the United States.

Lung cancer is the leading cause of cancer death in the world and the leading cause of cancer death in China. Lung cancer is generally divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Among them, NSCLC accounts for 80% - 85%, and about 3% - 7% of NSCLC patients have ALK gene mutations. Some patients with ALK positive advanced NSCLC had brain metastases at the initial diagnosis, and the incidence increased with time, which posed a severe challenge to the survival of patients.

The new generation ALK inhibitor CGT-9475 under research by the company aims to overcome drug resistance and solve the problem of central nervous system metastasis through high-quality and differential development. In preclinical studies, the drug can simultaneously inhibit ALK and RET in non-small cell lung cancer cell lines. At the same time, the drug showed good blood-brain barrier penetration effect in preclinical studies, which will bring new hope to NSCLC patients with brain metastasis. Therefore, CGT-9475 is expected to be used in the follow-up treatment after the resistance of existing ALK inhibitors.

Dr. Wang Tong, chief scientific officer of CGeneTech, said: "I am very glad that cgt-1881 and CGT-9475 have been approved to enter the clinical stage by both China and the United States. Through high-quality and differentiated development, CGT-9475 can inhibit ALK and RET at the same time, and is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of NSCLC. It has a broader market. I hope that CGT-9475 can be promoted in clinical trials in China and the United States as soon as possible, and benefit patients worldwide as soon as possible."

CGeneTech was founded in Suzhou Industrial Park in 2010. The core team has decades of experience in the whole life cycle of international drugs, and is committed to the R & D and industrialization of small molecule innovative drugs for breakthrough therapies. Relying on the integrated drug R & D technology platform and diversified business vision, the company has built a rich pipeline of innovative drugs, covering many disease fields such as glucose lowering, anticancer and rare diseases.