By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received additional indication approval from the National Medical Products Administration (NMPA) for its Aisuda (ivarmacitinib), a Category 1 drug. The approval now includes the treatment of adult patients with severe alopecia areata.
Drug Profile and Previous Indications
Aisuda, China’s first homegrown highly selective JAK1 inhibitor, was previously approved for ankylosing spondylitis, rheumatoid arthritis, and atopic dermatitis.
Clinical Trial Results
The latest approval is supported by a randomized, double-blinded, placebo-controlled Phase III study conducted across 31 hospitals in China, involving 330 adult patients with severe alopecia areata. By the 8th week of treatment, both the 4mg and 8mg dose groups showed higher SALT score ≤20 response rates compared to the placebo group. By the 24th week, the response rates reached 34.9% and 40.6% for the 4mg and 8mg groups, respectively. Throughout the 52-week treatment period, SALT scores continued to decrease, with an overall favorable safety profile.-Fineline Info & Tech