Junshi Biosciences Announces Acceptance of Supplemental Application for Additional Indications of Adalimumab Injection

0

Junshi Biosciences

— Additional indications: treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis and pediatric Crohn’s disease

SHANGHAI, China, Aug. 17, 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, today announced that the Company has received notice of acceptance from the National Medical Products Administration (“NMPA”). The company’s supplemental application for additional indications of adalimumab injection (project code: UBP1211, trade name: 君迈康), including the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, childhood plaque psoriasis, and childhood Crohn’s disease has been accepted.

Tumor necrosis factor-α (TNF-α) is secreted by macrophages, mast cells and activated Th cells. It is a potent inducer of the inflammatory response and a key regulator of innate immunity, playing a key role in the onset and development of various inflammatory conditions. Binding of TNF-α to TNF-α receptors can induce inflammatory responses, and rheumatoid arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis, and many other autoimmune diseases have been shown to be closely linked to TNF-α. Anti-TNF-α monoclonal antibodies can bind to TNF-α receptors and reduce the immune response activated by TNF-α, thereby preventing the occurrence of inflammation.

君迈康 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.

About uveitis
Noninfectious, posterior, or panuveitis intermediate (NIIPPU) is a group of immune-mediated intraocular inflammatory diseases that can lead to complications such as synechia, glaucoma, cataracts, macular edema, and retinopathy in patients, causing impaired vision or even blindness, and usually co-occurs with immune-mediated systemic diseases such as psoriasis and ankylosing spondylitis. According to epidemiological research data in mainland China, its incidence rate is 152/100,000, and the incidence peaks between 24 and 44 years of age.

About Crohn’s Disease
It is a chronic, relapsing inflammatory gastrointestinal disease, categorized as inflammatory bowel disease (IBD) along 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 shows a rapid rising trend. There is currently no complete cure for Crohn’s disease. The goal of treatment is to induce and maintain remission, prevent complications, and improve quality of life.

About Crohn’s Disease in Children
According to statistics, 25-30% of all IBD patients worldwide are children, of whom Crohn’s disease accounts for the vast majority, and its incidence rate is increasing year by year.

About Polyarticular Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis is a common rheumatic disease in children, with chronic joint synovitis as the main symptom. Accompanied by systemic dysfunction of several organs, it is also an important cause of disability and blindness in children. Polyarticular juvenile idiopathic arthritis is the most common subtype of juvenile idiopathic arthritis, accounting for approximately 18% to 30%.

About Plaque Psoriasis in Children
Pediatric psoriasis is a chronic, relapsing, inflammatory and systemic immune-mediated disease that occurs in children. Different populations, races and genders are also susceptible, and about 1/3 of patients have childhood onset of psoriasis. 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%).

About Junshi Biosciences
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 therapies. The company has established a diverse R&D pipeline comprising more than 50 drug candidates, with five therapeutic areas covering cancer, autoimmune, metabolic, neurological and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company to obtain marketing authorization for an anti-PD-1 monoclonal antibody in China. Its first-in-man 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 China. and in the United States. 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 has been strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to fight COVID-19, taking the lead in assume the social responsibility of Chinese pharmaceutical by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, Institute of Microbiology, Chinese Academy of science and Lilly. JS016 administered with bamlanivimab has obtained Emergency Use Authorizations (EUAs) in more than 15 countries and regions worldwide. As of December 3, 2021, more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new anti-SARS-CoV-2 oral nucleoside analogue drug designed to hamper virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 to that of nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk of progression to severe COVID-19, reached pre-specified primary endpoint and secondary efficacy endpoint. Study results show that, compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are part of the company’s continued innovation for disease control and global pandemic prevention.

Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.

Contact details of Junshi Biosciences
IR Team:
Junshi Biosciences
[email protected]
+ 86 021-6105 8800

PR team:
Junshi Biosciences
Zhi Li
[email protected]
+ 86 021-6105 8800

Share.

Comments are closed.