Simcere Pharmaceutical Group Limited (Simcere Pharma) has voluntarily withdrawn its New Drug Application for Rademikibart—an IL-4Rα monoclonal antibody co-developed with Connect Biopharma Hong Kong Limited—for adult and adolescent atopic dermatitis. The company plans to resubmit the application to China’s National Medical Products Administration within April 2026, describing the move as a strategic optimization of the product’s commercialization plan.

Phase 3 clinical results underpin the resubmission strategy: • Rapid onset: By Week 16, Rademikibart achieved response rates of 74.20% for EASI-75, 43.00% for EASI-90 and 47.70% for IGA 0/1 (all p<0.0001). • Sustained, deep remission: By Week 52, response rates rose to 96.60% for EASI-75, 85.30% for EASI-90 and 87.10% for IGA 0/1.

Rademikibart targets IL-4Rα to inhibit IL-4 and IL-13 signaling, blocking the Th2 inflammatory pathway implicated in atopic dermatitis and other diseases such as asthma.

Simcere Pharma, headquartered in Hong Kong, focuses on neuroscience, oncology, autoimmune and anti-infection therapeutics. The company states it will maintain close communication with regulators to secure market approval for Rademikibart as soon as possible.