Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of the whole industry chain, and Junshi (1877.HK, 688180.SH) jointly announced that the supplementary application for Adalimumab (trade name: 君迈康®, Mabwell Program Code: 9MW0113, Junshi Program Code: UBP1211) for the treatment of Crohn's disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis and pediatric Crohn's disease was approved by National Medical Products Administration (NMPA). Up to now, 君迈康® has been approved for 8 indications in China cumulatively.

Tumor necrosis factor-α (TNF-α), secreted by macrophages, mast cells and activated Th cells, is a potent inducer of inflammatory response and a key regulator of innate immunity, and plays a central role in the initiation and development of a variety of inflammation. The binding of TNF-α to its receptor can induce inflammatory responses. It has been demonstrated that TNF-α is closely related to a variety of autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn's disease, ankylosing spondylitis. Anti-TNF-α monoclonal antibody can bind to TNF-α receptor and reduce TNF-α-activated immune response, thereby preventing inflammation.

君迈康® has received support from the Major Scientific and Technological Special Project for Significant New Drug Development during China’s Twelfth Five-year Plan Period. In March of this year, the marketing application of 君迈康® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis was approved by NMPA.

Dr. Liu Datao, co-founder and CEO of Mabwell, said that "I am pleased to see that the expansion of 5 indications for 君迈康® has accomplished at once in a short time. So far, there are still a large number of patients suffering from autoimmune diseases, which seriously affect their physical function and quality of life. The indication expansion for 君迈康® can further benefit patients with autoimmune diseases in China and even globally, providing them with a treatment option with better efficacy and greater accessibility. ”

Dr Li Ning, CEO of Junshi Biosciences, said that "We are pleased that the commercialization process of 君迈康® is rapidly advancing, with 8 indications being approved within 1 year of clinical application, making it one of the domestic Adalimumab with the greatest number of approved indications. We will continue to work together with Mabwell to provide more treatment options for a broader range of patients with autoimmune disease, including adult or pediatric patients with specific diseases, and contribute to the construction of Healthy China! ”

About uveitis:

Noninfectious intermediate, posterior, and pan uveitis is a group of immune-mediated intraocular inflammatory diseases, which may cause complications such as iris adhesion, glaucoma, cataract, macular oedema, disorder retinal, leading to visual impairment and even blindness, commonly accompanied by immune-mediated systemic diseases such as psoriasis and ankylosing spondylitis. Data from epidemiological studies in mainland China showed an incidence of 152/100,000, with a peak incidence of 24 to 44 years of age.

About Crohn's disease:

Crohn's disease is a chronic and recurrent inflammatory gastrointestinal disease, which, together with ulcerative colitis (UC), belongs to inflammatory bowel disease (IBD). In China, the prevalence of Crohn's disease is 2.29/100,000, with an average incidence of 1.21/100,000, which is rapidly increasing. Crohn's disease cannot be completely cured. The purpose of treatment is to induce and maintain remission, prevent complications, and improve quality of life.

About pediatric Crohn's disease:

According to statistics, 25%-30% of all patients with inflammatory bowel disease in the world are children, of which Crohn's disease accounts for the vast majority, and its incidence tends to increase year by year.

About polyarticular juvenile idiopathic arthritis:

Juvenile idiopathic arthritis is a common rheumatic disease in childhood, characterized by chronic synovitis, and accompanied by multiple organ dysfunction. It is also an important cause of disability and blindness in childhood. Polyarticular juvenile idiopathic arthritis is a common subtype of juvenile idiopathic arthritis, accounting for about 18%-30% of all juvenile idiopathic arthritis.

About pediatric plaque psoriasis:

Pediatric psoriasis is an immune-mediated chronic, recurrent, inflammatory, systemic disease that occurs in children and is generally susceptible to various populations, races, and sexes. Approximately one third of patients develop the disease in childhood. The common type of psoriasis in older children is plaque psoriasis (75%), followed by guttate psoriasis (15%-30%), and generalized pustular psoriasis (1%-5.4%).