Recently, Hengrui Pharmaceuticals' subsidiary, Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, agreeing to conduct a clinical trial of SHR-1819 Injection for patients with Prutigo nodularis (PN).

PN is a chronic, inflammatory skin disease clinically characterized by episodes of intense itching and multiple nodular lesions. The main clinical symptom is intense, recurrent itching accompanied by uncontrollable scratching, which leads to hyperkeratosis of the skin to the point of forming dome-shaped nodules.1 PN leads to the development of psychological disorders in patients who face a significant reduction in quality of life, reduced sleep quality, and anxiety and depression. According to Frost & Sullivan, the number of PN patients in China will be approximately 2 million in 2022 and is expected to reach 2.1 million in 2030.

To date, there is no standard diagnosis and treatment program for PN, and the goal of treatment is mainly to reduce itching symptoms and stop the vicious cycle of itching to scratching. Traditional treatments include topical moisturizers and other topical medications2 in addition to therapies such as systemic immunosuppressants, opioid antagonists, antiepileptic analogs, antidepressants, and phototherapy. However, there are drawbacks such as insignificant effect, easy recurrence or and high side effects. With the development of biologic therapies, more and more evidence suggests that targeting and blocking key cytokines or mediators in the pathogenesis of PN has positive significance in the treatment of PN.

Epithelial-derived cytokines are continuously released in the grasping of PN, leading to the upregulation of IL-4 and other type 2 cytokines in PN lesions, which further contributes to the inflammatory response.3 Patients with PN also have elevated plasma levels of IL-13 compared to healthy individuals.4 SHR-1819 injection is a recombinant, humanized monoclonal antibody targeting human IL-4Rα independently developed by Hengrui Pharmaceuticals. It is capable of blocking both IL-4 and IL-13 signaling and is intended for the treatment of type 2 inflammation-related diseases. Currently, there is only one drug with the same target approved for marketing in the world.

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