Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody
SHANGHAI, China, Aug. 27, 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) of China has accepted an investigational new drug application for UBP1213sc, its subcutaneous injection of recombinant humanized anti-BLyS monoclonal antibody.
About UBP1213sc
UBP1213sc is a subcutaneous injection of a recombinant humanized anti-B lymphocyte stimulator (“BLyS”) monoclonal antibody, which is used to treat Systemic Lupus Erythematosus (“SLE”).
In November 2016, the intravenous dosage form (IV) of UBP1213 was approved by the NMPA for clinical trial. Junshi Biosciences was the first domestic company to obtain the approval for investigational new drug (IND) application for an anti-BLyS target monoclonal antibody drug. The subcutaneous injection has certain advantages over IV administration, including the flexibility to allow patients to administrate the drug themselves after training, which improves patient compliance.
About Systemic Lupus Erythematosus (“SLE”).
SLE is a highly heterogeneous systemic autoimmune disease with limited treatment options. According to the data in the Journal of Rheumatology and the Journal of Arthritis Research & Treatment, the current prevalence of SLE is 0-241/100,000 globally and 30-70/100,000 in mainland China. SLE is characterized by overactive B cells and massive autoantibody production. An anti-BLyS monoclonal antibody can inhibit the proliferation and survival of B cells by combining itself with soluble BLyS, so as to achieve long-term alleviation of SLE and reduce the risk of recurrence.
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: .
Contact Information
IR Team:
Junshi Biosciences
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Solebury Trout
Bob Ai
PR Team:
Junshi Biosciences
Zhi Li
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