Qin Hao Pharmaceutical's new SHP2 inhibitor clinical trial application was approved in the U.S.

October 30, 2021

Recently, Qinhao Pharmaceutical announced that its strategic partner Huya Bio-International has submitted a new drug clinical trial application for GH21 to the U.S. Food and Drug Administration (FDA). GH21 is a small molecule SHP2 inhibitor independently developed by Qinhao Pharmaceutical and has global intellectual property rights. It has strong biological activity and is effective against a variety of SHP2 point mutants. In vivo and in vitro studies have shown that GH21 has no significant effect on phosphatase, kinase and safety-related targets other than SHP2, and the risk of off-target is low; at the same time, it has excellent metabolic properties, high oral bioavailability, and good safety. The safety window is a small molecule anti-tumor drug with great development potential. In July 2020, Qinhao Pharmaceutical and Huya Bio-International reached an exclusive license agreement. Qin Hao Pharmaceutical has granted its SHP2 inhibitor GH21 product development and commercialization rights outside of China to Huya Biological International. Huya Biological International will pay a down payment and milestone payment of up to 282 million U.S. dollars for this purpose. Qin Hao Pharmaceutical will also obtain GH21 products in the market. Sales commission after overseas listing. This time GH21 was approved by the IND in the United States, and Qinhao Pharmaceutical will also receive corresponding milestone payments.

About SHP2

SHP2 is the first cancer-promoting phosphatase discovered in the world. In recent years, SHP2 has received extensive attention. On the one hand, SHP2 is downstream of most RTKs, mediating RTK to RAS-MAPK/PI3K-mTOR and other key signaling pathways for cell growth and survival. On the other hand, SHP2 is also downstream of immune checkpoints such as PD1 and BTLA, and mediates tumor immune escape signals. Therefore, SHP2 can play a dual role in tumor targeting and tumor immunity, and is a potential anti-tumor target. In addition, the combined use of SHP2 inhibitors and multiple drugs, including immune checkpoint drugs, has a good effect. It is one of the most promising targets in the anti-tumor field in recent years, but there are currently no SHP2 inhibitors on the market globally.

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