The board of directors of the Company (the “Board”) is pleased to announce that the clinical trial application of the Group’s anti-PD-1 monoclonal antibody (“609A”) has been approved by the National Medical Products Administration (“NMPA”). The Group has previously received an approval from the U.S. Food and Drug Administration in January 2019 to conduct clinical trials for 609A. Currently, the patient enrollment for the phase I clinical trials in the United States (“US”) is in smooth progress. The Company will initiate the patient enrollment for the clinical trials of 609A in China as soon as possible.

About 609A 

609A is a type of recombinant humanized monoclonal antibody which targets programmed cell death-1 (“PD-1”) and is used for the treatment of various cancers. PD-1, a T cells inhibitory receptor, is a kind of important immunosuppressive component that is mainly expressed in activated T cells and B cells, and can be used as a stop signal to inhibit the activation of T cells in tumors. Anti-PD-1 antibody recovers the function of T cells by blocking PD-1, thereby impeding the occurrence of tumors. It has the potential for the treatment of various types of cancers either as a monotherapy or in combination with other therapies. 

 Dr. LOU Jing, the chairman and chief executive officer of the Company, commented, “We are pleased to have received the approval for clinical trials of anti-PD-1 antibody from the NMPA and we have started the patient enrollment for clinical trials in the US. We look forward to accelerating progress of the clinical trials in both China and the US. The Company will explore various combination therapies for the treatment of different solid tumors and conduct a number of clinical trials, and strive to develop unique combination therapies. 3SBio will continue to look for opportunities and endeavour to explore and develop safer and more effective therapeutic biological agents, so as to meet the urgent medical needs and provide the patients with important treatment options.”