“We are very pleased with the rapid commercialization of 君迈康—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 君迈康 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 君迈康’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.”
It is a chronic and relapsing inflammatory gastrointestinal disease, which is categorized as inflammatory bowel disease (IBD) together with ulcerative colitis (UC). In China, the prevalence rate of Crohn’s disease is 2.29/100,000, the average incidence rate is 1.21/100,000, and it is showing a rapid upward trend. There is currently no complete cure for Crohn’s disease. The goal of treatment is to induce and sustain remission, prevent complications, and improve quality of life.
About Crohn’s Disease in Children
According to statistics, 25% to 30% of all IBD patients in the world are children, of which Crohn’s disease accounts for the vast majority, and its incidence rate has been increasing year by year.
Pediatric psoriasis is an immune-mediated chronic, recurrent, inflammatory, systemic disease that occurs in children. Different populations, races, and genders are equally susceptible, and about 1/3 of patients have onset of psoriasis in childhood. The common type of psoriasis in older children is plaque psoriasis (75%), followed by guttate psoriasis (15% to 30%) and generalized pustular psoriasis (1% to 5.4%).
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 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 over 50 drug candidates, 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 monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.
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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