Junshi Biosciences Announces Approval of Supplemental Application for Additional Indications of Adalimumab Injection
SHANGHAI, China, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“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 supplemental application for additional indications of adalimumab injection (project code: UBP1211, trade name: ???®) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children has been approved by the National Medical Products Administration (“NMPA”).
Tumor necrosis factor-a (TNF-a) is secreted by macrophages, mast cells and activated Th cells. It is a potent inducer of inflammatory response and a key regulator of innate immunity, playing a key role in the occurrence and development of various inflammatory conditions. The binding of TNF-a to TNF-a receptors can induce inflammatory responses, and it has been proven that rheumatoid arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis and many other autoimmune diseases are closely related to TNF-a. Anti-TNF-a monoclonal antibodies can bind to TNF-a receptors and reduce the immune response activated by TNF-a, thereby preventing the occurrence of inflammation.
??? is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd. In March 2022, its indications including rheumatoid arthritis, ankylosing spondylitis and psoriasis were approved by the NMPA.
“We are very pleased with the rapid commercialization of ???—since its clinical use less than a year ago, it has already been approved for 8 indications and become one of the domestic adalimumab with the most indications approved in the nation,” said Dr. Ning Li, CEO of Junshi Biosciences. “We will continue collaborating with Mabwell Biosciences to provide more treatment options for a wider range of patients with autoimmune diseases, including children and adults with specific diseases, and further the Healthy China Innitiative with our dedicated efforts.”
"It was wonderful to see ??? achieve 5 indication approvals all at once within a relatively short amount of time,” said Dr. Datao Liu, co-founder and CEO of Mabwell Bioscience. “To this day, many patients in China are still suffering from autoimmune diseases, which severely affect their physical functions and quality of life. The extension of ???’s indications will further benefit patients in China as well as the rest of the world, providing them with treatment options that are both more effective and accessible.”
About Crohn’s Disease
About Crohn’s Disease in Children
About Polyarticular Juvenile Idiopathic Arthritis
About Plaque Psoriasis in Children
About Junshi Biosciences
In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.
Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.
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