China’s Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate SIM0278, which is intended to treat moderate to severe atopic dermatitis (AD). This development marks a significant step forward in addressing the needs of patients suffering from AD.
SIM0278: A Treg-Preferred IL2 Fusion Protein for Autoimmune Diseases
SIM0278 is a regulatory T cell (Treg)-preferred IL2 fusion protein (IL-2 mu-Fc) developed on Simcere’s proprietary protein engineering technology platform. This innovative drug can be subcutaneously administered and is designed to treat various autoimmune diseases. In multiple preclinical disease models, SIM0278 has demonstrated significantly optimized pharmacokinetic (PK) properties, capable of selectively activating Treg cells without activating effector T cells or NK cells, thus restoring the immune balance of the body.
Strategic Licensing Deal with Almirall S.A.
In September 2022, Simcere struck a significant USD 500 million licensing deal with Spain-based Almirall S.A. (BME: ALM). This agreement grants Almirall exclusive development and commercialization rights to SIM0278 in markets outside of Greater China, highlighting the global potential of this drug candidate and expanding its reach to patients worldwide.-Fineline Info & Tech