Simcere's IL-2 Mutant Fusion Protein SIM0278 Entered Phase II Clinical Trial Stage

About this update from Simcere Pharmaceutical Group Limited

NANJING, China, Nov. 10, 2025 /PRNewswire/ -- Simcere Pharmaceutical Group (2096.HK) announced that its regulatory T cells（Treg）-preferential IL-2 mutant Fc fusion protein (IL-2 mu-Fc), SIM0278, has officially entered a Phase II clinical study in China for the treatment of moderate-to-severe atopic dermatitis (AD). The first dose was achieved in Hangzhou First People's Hospital. This randomized, double-blind, placebo-controlled, multi-center Phase II study is aiming to evaluate the efficacy, safety, and pharmacokinetics of continuous subcutaneous administration of SIM0278 in participants with moderate-to-severe AD. Atopic dermatitis is a chronic, recurrent, inflammatory skin disease characterized by symptoms such as dry skin, intense itching, and erythema, which significantly impact patients' quality of life. As a high medical need for the treatment of moderate to severe AD remains, there are opportunities to further optimise treatment options and technologies. The critical role of Treg cells in peripheral immune tolerance is a major focus in current immunology research and was recently awarded the 2025 Nobel Prize. SIM0278 was developed on Simcere's proprietary protein engineering platform. Its mechanism of action involves introducing mutations that reduce its affinity for effector T cells while maintaining high affinity for Tregs. This selectivity allows SIM0278 to activate Tregs specifically, helping to restore immune balance without affecting effector T cells or natural killer cells and shows potential for treating a variety of immune disorders. SIM0278 has demonstrated good tolerability, appropriate pharmacokinetic properties, and preliminary efficacy in the completed Phase I clinical study in China. It is expected to achieve sustained efficacy and become a best-in-class (BIC) product. "We are excited about what SIM0278's entry into Phase II means for AD patients and the long-term management of the disease. This partnership reinforces our commitment to pushing the boundaries of science and patient-centric innovation to deliver impactful solutions for unmet dermatological needs", said Karl Ziegelbauer, Chief Scientific Officer at Almirall. "The clinical progress of SIM0278 significantly strengthens Simcere's leading position in the field of autoimmune diseases." Said Dr Aik H Goh, MD , Chief Medical Officer...

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