Simcere agree license deal of $492M USD with Almirall

Almirall granted exclusive rights to commercialise SIM0278 for all indications outside the Greater China region, (Mainland China, Hong Kong, Macau and Taiwan)

NANJING, CHINA, October 6, 2022 /EINPresswire.com/ -- 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 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 a pharmaceutical company driven by innovative R&D and committed to synergistic innovation. It has established the State Key Laboratory of Translational Medicine and Innovative Drug Development and currently boasts four R&D centers in Shanghai, Nanjing, Beijing and Boston. With the commitment to "providing today's patients with medicines of the future", the Company focuses on three therapeutic areas: oncology, central nervous system diseases, and autoimmune diseases, while actively expanding its strategic presence in prospective disease areas with significant clinical needs in the future.

Simcere now has six global first-in-class innovative drugs, and is holding leading market shares for its key products in China with its excellent R&D and commercialization capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with international and domestic leading innovative pharmaceutical enterprises, medical institutions and research institutes. Moreover, Simcere has been recognized as one of the “Top 10 Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China” for several consecutive years.

Simcere website：
www.Simcere.com

linkedIn：
https://www.linkedin.com/company/simcere-pharmaceutical-group

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s 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.

Website ： almirall.com
LinkedIn：https://www.linkedin.com/company/almirall/

Highlights:

• Simcere will receive a $15 million upfront payment, and up to $492 million in total development and commercial milestone, as well as up to low double-digit tiered royalties based upon future global sales.
• The deal's total amount set a record high, for the out-licensing of preclinical autoimmune assets in China.
• Under the agreement, Almirall will be granted an exclusive right to develop and commercialise SIM0278 for all indications outside of the Greater China region
• SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu Fc) that selectively activates regulatory T cells. As an IND ready subcutaneous injection, good efficacy has been demonstrated in multiple preclinical disease models with Best-in-Class potential. It can be developed to potentially treat various autoimmune diseases
• By closing the new deal, Simcere as a China based biopharma aiming to go global, had proven its ability of novel drug development and a branding of “partner of choice” that emphasis on synergy with global partners to accelerate new drug developed and marketing around the world.

Yiling Li
Simcere Pharmaceutical Group
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