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The dupliumab injection declared by Sanofi (SNY.US) has been granted an implied license for a new clinical trial.
The Zhitong Finance App learned that on November 26, the Drug Evaluation Center (CDE) website of China's State Drug Administration (CDE) recently announced that the duplimumab injection declared by Sanofi (SNY.US) has been granted a new implied clinical trial license to be developed to treat adult patients with moderate to severe chronic simple lichen with poor external medication control. According to public information, globally, dupriumab injection is undergoing phase 3 clinical research on lichen simplex indications. This is the first time that it has been clinically approved 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 erythema with clear boundaries, often accompanied by hyperpigmented and thickened lichen-like plaques. The disease is caused by prolonged friction and scratching, and most commonly occurs on the neck, ankles, scalp, perineum, vulva, scrotum, and side of the forearm. Although neurodermatitis is not life-threatening or contagious, the itching can be so intense that it affects sleep, sexual function, and quality of life. The vicious cycle of getting more itchy with neurodermatitis is difficult to break, and this condition usually lasts for a long time. It may subside after treatment, but it often recurs. Treatment for this disorder focuses on controlling itching and preventing scratching, as well as identifying and eliminating factors that worsen symptoms and intervening.
Dupilumab (dupilumab) is the first anti-IL-4Rα antibody approved by the US FDA and was jointly developed by Sanofi and Regeneron (REGN.US). It can block type 2 inflammatory pathways through the innovative mechanism of action of IL-4 and IL-13 “dual targets”, reduce the pathological response of type 2 inflammation, and mechanically treat type 2 inflammation-related diseases. Studies have shown that IL-4 and IL-13 are key drivers of type 2 inflammation and play an important role in various inflammatory diseases.
According to the ClinicalTrials website, Sanofi and Regenerative are conducting two international multi-center phase 3 clinical studies (STYLE 1 and STYLE 2) to evaluate the efficacy and safety of priliumab compared to placebo to improve the efficacy and safety of pruritus in patients with chronic lichen simplex.
