Simcere and Almirall Enter into a Licensing Agreement for IL-2 mu-Fc

Simcere Pharmaceutical Group an innovation and R&D-driven pharmaceutical company, and Almirall SA a global biopharmaceutical company focused on skin health; announced today that they have 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 commercialise 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 $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." Said Renhong Tang, Ph.D., Co-CEO of Simcere, "SIM0278 is one of the key molecules developed based on Simcere's in-house protein engineering platform. This partnership also marks a milestone of Simcere's globalization 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," stated 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. About SIM0278 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. About Simcere Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes

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