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Simcere and Almirall Enter into a Licensing Agreement for IL-2 mu-Fc of 492M USD

Simere and Almirall logo

The deal's total amount set a record high, for the out-licensing of preclinical autoimmune assets in China.

Simcere (2096.HK:2096.HK)

NANJING, JIANGSU, CHINA, October 1, 2022 / -- Simcere Pharmaceutical Group(2096.HK), an innovation and R&D-driven pharmaceutical company, and Almirall S.A. (BME: ALM), 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 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 commercialize 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 in 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 commercialization 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 biological 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 an 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

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About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patients’ needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70.
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Media contact Almirall: Investors’ Relations contact
Tinkle Almirall
Laura Blázquez Pablo Divasson del Fraile
Phone: (+34) 600 430 581 Phone: (+34) 93 291 3087

Corporate Communications contact:
Mar Ramírez
Phone: (+34) 659 61 41 73

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