Hengrui Pharmaceutical's innovative drug SHR-1701 injection and famitinib malate capsules were approved for clinical use

Recently, Hengrui Pharmaceutical received the "Notice of Approval of Drug Clinical Trials" approved by the State Drug Administration, which approved the company to carry out open and multicenter Phase II clinical trials of SHR-1701 combined with famitinib malate or SHR-1701 single drug for advanced or metastatic non-small cell lung cancer.

Lung cancer is the most common malignancy in the world, with the highest incidence and mortality rate of malignant tumors, and non-small cell lung cancer (NSCLC) accounts for about 85% of the total lung cancer. In recent years, immunotherapy represented by PD-1/PD-L1 inhibitors has made breakthroughs in advanced NSCLC treatment, changing the pattern of advanced or metastatic NSCLC treatment without sensitive driver genes, and PD-1/PD-L1 inhibitors have gradually become new standards for first- and second-line treatment of NSCLC.

SHR-1701 injection is an anti-PD-L1/TGF-βRII bifunctional fusion protein independently developed by Hengrui Pharmaceutical and has intellectual property rights, which can block the PD-1/PD-L1 pathway and neutralize the TGF-β in the tumor microenvironment, and the joint inhibition of negative signals of PD-1 and TGF-β can bring more effective anti-tumor immune response than any single pathway inhibition, and enhance anti-tumor efficacy.

Famitinib malate capsule is a small molecule multi-target tyrosine kinase inhibitor innovatively developed by Hengrui Pharmaceutical, which has good inhibitory activity against a variety of receptor tyrosine kinases such as c-Kit, VEGFR1/2/3, PDGFRα/β, FGFR2/3, Ret, Axl, Mer, Flt3 and Fms. At present, clinical research at different stages including advanced solid tumors, nasopharyngeal carcinoma, non-small cell lung cancer, gastrointestinal stromal tumor, neuroendocrine tumor, renal clear cell carcinoma, colorectal cancer, bile duct carcinoma and other indications is being carried out in China.

Anti-angiogenic drugs can regulate the immune microenvironment and improve the effect of immunotherapy, and the results of preclinical studies have also confirmed that SHR-1701 combined with famitinib malate has a synergistic anti-tumor effect. On the basis of SHR-1701 combined with famitinib malate, it can better remove negative inhibitory cytokines in the tumor microenvironment, activate the activity of killer T cells, and synergistically improve the immune system's ability to kill tumors, which is expected to provide a new option for advanced NSCLC treatment.