Express delivery unlimited cancer therapy, Zhijian Jinrui Bio's second-generation RET inhibitor was approved for clinical use in the United States

▎WuXi AppTec Content Team Report On January 24, Beijing Zhijian Jinrui Biomedical Technology Co.
, Ltd.
(hereinafter referred to as "Zhijian Jinrui Company") announced that its self-developed second-generation RET inhibitor APS03118 clinical trial application ( IND) has been approved by the US FDA
.

At the same time, the company is also submitting a clinical trial application for APS03118 to the National Medical Products Administration (NMPA) of China
.

Zhijian Jinrui plans to start a global multi-center clinical trial of the drug in the United States, China, and Australia in the second quarter of 2022
.

Founded in 2011, Zhijian Jinrui is a biopharmaceutical company dedicated to the development of precision cancer therapies
.

Through in-depth exploration of oncogenic driver genes, protein structure and function, and synthetic medicinal chemistry, the company hopes to develop a new generation of cancer precision therapies targeting tumor driver genes, bringing new options and hope to cancer patients around the world
.

According to the press release, APS03118 is a class 1 innovative drug independently developed by Zhijian Jinrui, which is not limited to cancer types.
It is intended to be developed for the treatment of non-small cell lung cancer, thyroid cancer, pancreatic cancer, and breast cancer caused by RET gene alterations.
, ovarian cancer, colorectal cancer and other advanced solid tumors, and patients with resistance to first-generation selective RET inhibitors
.

Preclinical studies have shown that APS03118 is highly selective for RET kinase
.

Compared with the first-generation selective RET inhibitors currently on the market, this drug candidate exhibits significant inhibitory effects at nanomolar levels against various RET fusions and mutant proteins, especially those that cause resistance to selective RET inhibitors.
Drug gatekeeper V804M/L/E and solvent front G810R/S/C mutations have stronger inhibitory effects
.

Studies in mouse models have also shown that APS03118 has potent antitumor activity and a favorable safety profile
.

Especially in the brain tumor model, the drug candidate can completely disappear the brain tumor, and all animals survive after the drug, which means that APS03118 has potential therapeutic advantages for patients with brain metastases
.

Dr.
Zhong Jun, Vice President of R&D of Zhijian Jinrui, said that he is very glad that the innovative drug APS03118 independently developed by the company has been approved by the FDA.
In response to the unmet clinical needs in the world, Zhijian Jinrui will always adhere to the international development strategy and provide cancer patients worldwide.
A new generation of precision treatment solutions
.

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