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

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 of Simcere," The initiation of Phase II clinical trials also marks a significant step forward in the project's global clinical development plan. We look forward to working with our partner to bring this innovative drug to patients worldwide as soon as possible."

In September 2022, Simcere signed an exclusive license agreement with Almirall, S.A., granting Almirall rights to develop and commercialize SIM0278 for all indications outside Greater China. The Phase I clinical study conducted by Almirall in the United States has been completed and a Phase II study on another skin condition will start in the coming months.

About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Anti-infection. We proactively explore areas with significant unmet needs, and our mission is Providing Today's Patients with Medicines of the Future. Our industry-leading capabilities and commitment to synergistic innovation have enabled various global strategic collaborations and we are seen as the partner of choice by industry peers, medical institutes, and research organizations across the globe.

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