慢性单纯性苔藓（LSC，亦称神经性皮炎）是一种常见皮肤病，特征为出现边界清晰的红斑，常伴色素沉着过度及增厚的苔藓样斑块。该病由长期摩擦和搔抓导致，最常发生在颈部、踝部、头皮、会阴、外阴、阴囊和前臂伸侧。尽管神经性皮炎不会危及生命，也没有传染性，但瘙痒可能非常强烈，以至于影响睡眠、性功能和生活质量。神经性皮炎越挠越痒的恶性循环很难打破，这种状况通常会长期持续。在治疗后可能消退，但往往还会复发。该疾病的治疗Sanofi (SNY.US) has received approval for a new clinical trial implicit license for dupilumab injection.
According to Zhito Finance APP, on November 26, the latest announcement from the Drug Evaluation Center (CDE) of China's National Medical Products Administration (NMPA) revealed that Sanofi (SNY.US) has received approval for a new clinical trial implicit license for dupilumab injection, which is intended for the treatment of moderate to severe chronic lichen simplex in adult patients who have inadequate control with topical medications. Public information shows that globally, dupilumab injection is undergoing Phase 3 clinical research for the indication of lichen simplex, and this is the first clinical approval for this indication in china.
Screenshot source: CDE official website
Chronic lichen simplex (LSC, also known as neurodermatitis) is a common skin disease characterized by clear-border red patches, often accompanied by hyperpigmentation and thickened lichen-like plaques. This condition is caused by long-term friction and scratching, most commonly occurring on the neck, ankles, scalp, perineum, vulva, scrotum, and the extensor surfaces of the forearms. Although neurodermatitis is not life-threatening and is non-contagious, the itching can be so intense that it affects sleep, sexual function, and quality of life. The vicious cycle of itching exacerbating scratching is difficult to break, and this condition usually lasts a long time. It may subside after treatment, but relapses often occur. The focus of treatment is to control itching and prevent scratching, as well as to identify and eliminate factors that exacerbate symptoms and intervene accordingly.
Dupilumab is the first anti-IL-4Rα antibody approved by the FDA in the usa, jointly developed by Sanofi and Regeneron (REGN.US). It can block the type 2 inflammation pathway through the innovative mechanism of action targeting both IL-4 and IL-13, reducing the pathological response of type 2 inflammation, thus providing mechanism-based treatment for type 2 inflammation-related diseases. Studies show that IL-4 and IL-13 are key drivers of type 2 inflammation and play important roles in various inflammatory diseases.
According to the ClinicalTrials official website, Sanofi and Regeneron are conducting two international multicenter Phase 3 clinical studies (STYLE 1 and STYLE 2) aimed at assessing the efficacy and safety of dupilumab in improving itching in patients with chronic lichen simplex compared to placebo.
