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ArticleMedicine Guanlan
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, 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 China National Medical Products Administration (NMPA) to conduct clinical trials.
This is a phase 1a/1b open, single-arm, multi-center study conducted 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
(The original text has been deleted)
Reference materials:
[1] The new SHP2 allosteric inhibitor ICP-189 independently developed by Nuocheng Jianhua was approved by the US FDA for clinical research.
