• SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates T regulatory cells. As an IND ready subcutaneous injection, it can be developed to potentially treat various autoimmune diseases.

Almirall S.A. has entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278.

Under the agreement, Almirall will be granted an exclusive right to develop and commercialize SIM0278 for all indications outside of the Greater China region (Mainland China, Hong Kong, Macau and Taiwan). Simcere will retain all rights to develop and commercialise SIM0278 within Greater China.

Within the terms of the agreement, Simcere will receive a $15 million upfront payment, and up to US$492 million in development and commercial milestone payments considering successful achievements in several indications, with an important part as sales milestones, as well as up to low double-digit tiered royalties based upon future global sales.

"We are very excited to have reached a collaborative agreement with Almirall for the development of SIM0278. This innovative IL-2 mutein is one important molecule of our immune-rebalancing strategy for autoimmune diseases”, says Renhong Tang, Ph.D., Co-CEO of Simcere, in a news release. “SIM0278 is one of the key molecules developed based on Simcere's in-house protein engineering platform. This partnership also marks a milestone for Simcere’s globalisation effort. We look forward to closely working with Almirall to demonstrate the clinical value of SIM0278.”

"At Almirall, we always look for new opportunities to strengthen our R&D pipeline. That is why we are very pleased to close this new development and commercialisation agreement with Simcere," states Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer. "SIM0278 has great potential to treat a broad spectrum of immunological diseases, and we expect that its development will allow us to reinforce our biologic pipeline and our leading position in Medical Dermatology.”

SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates regulatory T cells developed in-house by utilizing Simcere’s protein engineering platform. This IND ready subcutaneous injection will potentially be developed to treat various autoimmune diseases. SIM0278 exhibits improved PK profile and selective activation of Treg cells with no activation of effector T cells or NK cells to restore immune balance which has been demonstrated in multiple preclinical disease models.