NMPA Accepts Application for Clinical Trial of Bifunctional Fusion Protein

Shanghai Junshi Biosciences Co., Ltd. has announced that a clinical trial application for its PD-1/TGF-β bifunctional fusion protein JS201 injection (JS201) has been accepted by National Medical Products Administration (NMPA).

JS201 is a bifunctional fusion protein developed by Junshi using its proprietary technology that can simultaneously target PD-1 and TGF-β (transforming growth factor-β). It is the first product targeting PD-1/TGF-β approved for a clinical trial application in China. JS201 can effectively block the immunosuppressive pathways of PD-1 and TGF-β which improves the immunomodulatory effect in the tumor microenvironment, thereby promoting the killing effect of the patient's immune system on tumor cells and reducing the occurrence of immune escape and drug resistance.

"A hearty congratulations to our partner Junshi Biosciences on entering the new phase of JS201," said Dr. Yongzhong Wang, CEO of CMAB. "Utilizing our advanced integrated biological drug development platform, we provided CMC related services including cGMP production of drug substance and drug product for the JS201 project. We wish the JS201 clinical study success as we believe that this novel product can provide significant benefits for cancer patients."