Recently, Hengrui Pharmaceuticals' subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy.

Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis develop the disease in childhood [5]. Psoriasis that occurs in children and adolescents (age <18 years) is pediatric psoriasis, with the global prevalence of plaque psoriasis in children being approximately 1%.

Currently, the treatment of plaque psoriasis is mainly based on drug therapy, combined with phototherapy. Mild patients are mainly treated locally, while moderate to severe patients need systemic treatment or phototherapy, with drugs including retinoids, immunosuppressants, etc. Phototherapy can be used for those with extensive skin lesions. However, there are still some patients with moderate to severe disease who are not well treated. The use of phototherapy in children is more restricted, with medium-wave ultraviolet (UVB) light being used with caution in patients under 10 years of age, and Psoralen long-wave ultraviolet photochemotherapy (Psoralen ultraviolet A, PUVA) being contraindicated in patients under 12 years of age. The traditional immunosuppressive therapy has large side effects, and frequent monitoring of adverse drug reactions is required during the medication process to ensure the safety of use. Therefore, current domestic and international guidelines recommend the use of biologics in children with moderate to severe disease.

Fronachizumab (SHR-1314) is a recombinant humanized monoclonal antibody targeting human IL-17A independently developed by Hengrui Pharmaceuticals, which is intended to be used for the treatment of autoimmune diseases associated with the IL-17 pathway. It can bind to IL-17A and block its interaction with IL-17R, leading to the blockage of downstream inflammatory signaling.

A number of existing SHR-1314 clinical studies have been completed or are ongoing, including adult plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis, to evaluate its role in a variety of autoimmune diseases. Among them, marketing applications have been accepted for the indications for the treatment of adult patients with moderate-to-severe plaque psoriasis who are suitable for systemic therapy or phototherapy and adult patients with active ankylosing spondylitis who have poor efficacy on conventional therapy.

Based on the efficacy and safety of frontalizumab in adults with moderate-to-severe plaque psoriasis, Hengrui Pharmaceuticals plans to conduct efficacy and safety studies in pediatric and adolescent patients with moderate-to-severe plaque psoriasis between the ages of 6 and less than 18.

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