China's National Medical Products Administration (NMPA) approved local company Hengrui Pharmaceuticals' JAK1 inhibitor ivarmacitinib (SHR0302) for severe alopecia areata in adults on 30 June. The approval follows Phase III trial data showing 40.6% of patients receiving 8 mg daily achieved ≥80% scalp hair regrowth (Severity of Alopecia Tool score ≤20) at 24 weeks versus 9% for placebo (p<0.0001). By week 52, response rates rose to 63.1% (8 mg) and 46.8% (4 mg).

The multicentre trial (n=330) demonstrated ivarmacitinib's safety profile aligned with JAK inhibitor class effects, with no thromboembolic or major adverse cardiovascular events reported. Ivarmacitinib previously gained approvals for atopic dermatitis, ankylosing spondylitis and rheumatoid arthritis (RA).

Alopecia areata affects approximately 0.27% of China’s population, with existing therapies like corticosteroids showing limited efficacy and tolerability. Ivarmacitinib provides a new targeted option for this underserved patient population.