Junshi Biosciences Announces NMPA Acceptance of Investigational New Drug Application for JS014

SHANGHAI, China, June 28, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) has accepted its Investigational New Drug (IND) application for JS014.

In June 2019, Junshi Biosciences and Anwita Biosciences entered into a license agreement to develop and commercialize JS014 in the Greater China territories (including mainland China, Hong Kong, Macao, and Taiwan).

About JS014
JS014 is a novel recombinant IL-21 and anti human serum albumin (HAS) single domain nanobody fusion protein with a prolonged half-life. It is able to bind specifically to human IL-21R with high affinity and activate T-lymphocyte. The prolongation of half-life can expand the distribution of the drug and enhance the activity of tumor infiltrating lymphocytes in the tumor microenvironment, thereby improving the ability of the immune system to kill tumor cells.

Preclinical studies demonstrate that JS014 and JS001 (toripalimab) have strong synergistic antitumor effect.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences 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 28 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 and 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 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is 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). For more information, please visit: http://junshipharma.com.

Contact Information

IR Team:
Junshi Biosciences
+ 86 021-2250 0300

Solebury Trout
Bob Ai
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800