On July 27, 2023, SIM0278 injection, an IL-2 mutant Fc fusion protein independently developed by the Group, obtained the clinical trial approval issued by the National Medical Products Administration, and will soon be launched in clinical trials, exploring the solutions to continuous medication disturbance for patients with moderate-to-severe atopic dermatitis (AD). In September 2022, SIM0278 completed nearly $500 million of overseas licensing, and its clinical validation in the United States is currently in the process of synchronous and active layout.
SIM0278 approved for Phase I clinical study
Atopic Dermatitis (“AD”) is a chronic, recurrent, and inflammatory skin disease, the common clinical features of which include xerosis, erythema, edema, erosion, excoriation, lichenification, etc. The onset is often accompanied by strong pruritus and the illness often recurs, which seriously affects work and life and exerts heavy disease burden and psychological burden to patients. There is no radical cure for AD at present and safer and more effective therapeutic drugs are still needed clinically, so as to meet the needs of patients for disease control and continuous treatment.
Studies show that regulatory T cells (“Treg”) take part in the pathogenesis of AD, which plays an important role in immune tolerance and immune regulation, and it has been proven to be the key to down-regulate inflammation in skin allergic reactions and maintaining immune tolerance in the periphery.
SIM0278 is an Fc fusion protein with an IL-2 mutein, allowing preferential activation of Treg; it is developed on the Group’s protein engineering technology platform. By introducing relevant mutation, it reduces the affinity of SIM0278 with effector T cells, while maintaining high affinity with Treg cells. Pre-clinical studies show that SIM0278 can activate Treg cells selectively in vitro without activating effector T cells or NK cells, so as to achieve the function of restoring the immune balance of the body and exhibiting the potential for treating various autoimmune diseases.
The upcoming Phase I clinical study in China is designed to evaluate the safety tolerability, pharmacokinetics, and pharmacodynamics of SIM0278 in Chinese subjects.
On September 28, 2022, the Group entered into a license agreement with Almirall, S.A. (“Almirall”). Under the agreement, the Group granted Almirall an exclusive right to develop and commercialize SIM0278 outside the Greater China region, while maintaining all rights of the product in the Greater China region.
Simcere will continue to be guided by the huge unmet clinical needs, focus on being more effective, adhere to differentiation, and work with partners to fully promote the clinical validation of SIM0278 in the world, bringing a new choice of treatment for patients with autoimmune diseases around the world.