CMAB Biopharma Congratulates Partner Junshi Biosciences on NMPA Acceptance of Application for a Clinical Trial of its PD-1/TGF-β Bifunctional Fusion Protein

Recently, CMAB Biopharma (Suzhou) Inc's partner Shanghai Junshi Biosciences Co., Ltd., 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). JS201 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."

About Shanghai Junshi Biosciences Co., Ltd.

Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases.

Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China's first neutralizing fully human monoclonal antibody against SARSCoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

About CMAB Biopharma (Suzhou), Inc.

CMAB is a flexible full-service CDMO dedicated to providing bespoke development manufacturing services of antibodies and biologics for clients in China and across the globe. CMAB complies with global quality standards and has successfully completed a Qualified Person (QP) audit performed by Parexel.