Haichuang Pharmaceutical (688302.SH): Clinical trial application for HP570 tablets was approved by the US FDA

Zhitong Finance App News, Haichuang Pharmaceutical (688302.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”), and the clinical trial application for HP570 tablets independently developed by the company to treat rheumatoid arthritis was officially approved by the FDA.

According to the announcement, at present, the new drug clinical trial application (IND) for this project is still in the process of being reviewed by the Chinese Drug Supervisory Authority. It has been approved by the US regulatory agency FDA, and phase I clinical trials are about to commence. Preclinical studies have shown that this product has highly selective and potent target degrading activity. It has shown good efficacy in many animal models of autoimmune diseases. It is superior to similar VAV1 degrading agents in human immune cells, and is potentially the best oral VAV1 molecular gel degrader in its class; this product has good oral absorption and bioavailability, and is generally well tolerated in preliminary toxicological studies in rats and crab-eating monkeys. No serious toxicity signals clearly related to drug administration were observed.