Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has announced that the market filing for its JAK1 inhibitor, ivarmacitinib, for the treatment of moderate to severe atopic dermatitis (AD) has been accepted for review by the Center for Drug Evaluation (CDE) in China.
Global Competition and Domestic Gap in JAK1 Inhibitors
While oral JAK1 inhibitors such as Pfizer’s abrocitinib and AbbVie’s upadacitinib have been approved for marketing internationally, China has not yet seen a home-grown product of this kind. Ivarmacitinib is the first domestically developed JAK1 inhibitor to enter the marketing review process in China, indicating a significant step forward in the treatment options for moderate to severe AD.
Phase III Study Results and Implications
The filing is supported by a randomized, double-blind, placebo-controlled, global multi-center regulatory Phase III study involving 51 centers in China and Canada and 336 AD subjects. The study achieved its predetermined primary endpoint, which included the proportion of subjects with IGA response and EASI-75 response. Research results indicate that daily oral administration of 8mg or 4mg of ivarmacitinib can significantly improve clinical symptoms, quickly control itching, clear skin lesions, and improve the quality of life in patients with moderate to severe atopic dermatitis. Long-term efficacy data have demonstrated that ivarmacitinib at both doses can effectively maintain the response of IGA and EASI-75. Moreover, long-term safety data shows that both doses exhibit good safety and tolerability, with no new safety signals identified during the study period.-Fineline Info & Tech
