On November 15th, Nuocheng Jianhua announced that the company's self-developed new protein tyrosine phosphatase SHP2 allosteric inhibitor ICP-189 has been approved by the US FDA for clinical research, becoming the company's fourth clinical innovation approved in the United States medicine. This is an open-ended, single-arm, multi-center study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics and effectiveness of ICP-189 single-agent and combination therapy in patients with advanced solid tumors.

ICP-189 was developed for the treatment of solid tumors. It can be used as monotherapy and/or combination therapy with other anti-tumor drugs. It aims to provide new clinical treatments for solid tumors such as lung cancer, head and neck cancer and gastrointestinal tumors.

Preclinical studies have shown that ICP-189 is a highly selective oral SHP2 allosteric inhibitor, with good selectivity to other phosphatases. SHP2 is a non-receptor protein tyrosine phosphatase, which plays a role in the MAPK signaling pathway and immune checkpoint pathway, and can regulate cell proliferation and survival.

On October 19th, Nuocheng Jianhua announced that ICP-189 has been approved by the National Medical Products Administration (NMPA) of China to conduct clinical trials. This is a phase 1a/1b open, single-arm, multi-center study in China It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and effectiveness of ICP-189 single agent and combination therapy in patients with advanced solid tumors. This also makes ICP-189 the company's ninth innovative drug to enter the clinical stage.