Policy & Regulation
Shanghai Junshi Biosciences's JS201 injection clinical trial application approved by Chinese regulator
8 March 2021 -

China's National Medical Products Administration has accepted China-based Shanghai Junshi Biosciences Co Ltd's (HK: 1877)(SH: 688180) clinical trial application for its PD-1/TGF-beta bifunctional fusion protein JS201 injection, it was reported on Sunday.

The product is a bifunctional fusion protein produced by the company using its proprietary technology that can simultaneously target PD-1 and TGF-beta (transforming growth factor-beta). The product is the first aimed at PD-1/TGF-beta approval for a clinical trial application in China. It can effectively block the immunosuppressive pathways of PD-1 and TGF-beta, which is claimed to improve the immunomodulatory effect in the tumour microenvironment, thereby promoting the killing effect of the patient's immune system on tumour cells and decreasing the occurrence of immune escape and drug resistance.

Dr Yongzhong Wang, CEO of CMAB Biopharma (Suzhou) Inc, said, 'A hearty congratulations to our partner Junshi Biosciences on entering the new phase of JS201. Utilising 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.'



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