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.
Nanjing China and Barcelona Spain, September 29, 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 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.
I. Global Innovative Drugs
Simcere prioritizes the R&D of innovative drugs and generic drugs with high technical barriers based on ever-increasing and unmet clinical needs. To date, it has launched 6 global first-in-class innovative drugs, over 10 products have been included into the guidelines and pathways issued by more than 50 governmental agencies or authoritative professional associations in China, and more than 40 products have been included in China’s National Reimbursement Drug List.
The 6 global first-in-class innovative drugs include:
1. Sanbexin: the world’s only innovative drug approved for stroke since 2015, which can significantly reduce CNS damage caused by acute ischemic stroke
2. Iremod: the first iguratimod drug product in the world, which is the only small molecule DMARD, or disease-modifying anti-rheumatic drug, developed in China that has been approved over the past decade
3. Endostar: the first recombinant human endostatin in the world and the first innovative biologic product approved in China as first-line treatment for patients with NSCLC
4. Cosela: the world’s first and only “Chemo Guard” with multi-lineage myeloprotection
5. Enweida: the first subcutaneous PD-(L)1 antibody-based drug in the world and the first pan-tumor immunotherapy drug in China
6. Orencia: the first CTLA-4-Fc fusion protein in the world, providing another small molecule treatment option for rheumatoid arthritis
As of December 31, 2021, Simcere’s annual revenue has amounted to approximately CNY 5 billion. Specifically, the revenue of innovative drugs increased by more than 50% over the same period, occupying 62.4% of the total revenue that hits a record high.
II. Global R&D Professionals
Simcere has been continuously expanding its R&D investments. In 2021, its R&D investment was more than CNY 1.4 billion, accounting for 28.3% of the sales revenue. Additionally, it has established a whole-process R&D system integrating drug discovery, pre-clinical development, clinical trials, and drug registration, owns a R&D pipeline project of nearly 60 new drugs, and is conducting 20 clinical studies for registration of 16 potential innovative drugs.
As of August 2022, the Company has established a R&D team comprising over 1000 professionals, of whom more than 60% are professionals with a master’s or doctoral degree and more than 10% are professionals with an international education background.
III. International Standard-Based Pharmaceutical Bases
Simcere possesses 5 pharmaceutical bases in China, which can perform pharmaceutical practices by integrating drug substances and drug products, engage in the late-stage development and commercial manufacturing of macromolecular and micro-molecular drugs, and perform manufacturing and quality control as per the stringent international standards. All production workshops have passed GMP certification, the base in Hainan has passed EU GMP certification for multiple times in succession, and the manufacturing base for small-molecule drugs in Nanjing has passed FDA’s on-site inspection with “zero 483" (zero defect).
The Company has established a management system overseeing the entire production cycle from raw material procurement to drug product delivery, so as to ensure the whole-process compliance, continuously improve quality specifications, and safeguard patient safety.
IV. Academic Marketing
Simcere’s marketing system consists of four business units, namely, neuroscience, oncology, autoimmune & general disease, and grassroots retail. It boasts a professional academic promotion team comprising more than 4000 professionals, with members spanning across 31 provinces, municipalities, and autonomous regions. It has a portfolio of products serving more than 3000 tertiary hospitals, 37,000 non-tertiary hospitals and medical institutions, and over 280 large chain pharmacies, and can leverage the commercialization capability to quickly maximize the sales of its innovative drugs.
In pursuit of the principle of “Patient First”, Simcere always conducts academic promotion activities in compliance with laws and regulations, promotes compliance culture, and implements compliance requirements, providing professional academic information for medical and health professionals.
V. Synergistic Innovation
Simcere remains dedicated to synergistic innovation, and is committed to achieving mutually beneficial cooperation with leading innovative pharmaceutical enterprises, medical institutions, and research institutes in China and beyond. It has successively reached a series of strategic cooperation agreements with numerous globally leading multinational pharmaceutical groups and biotechnology companies including Bristol-Myers Squibb, G1 Therapeutics, Kazia, and Vivoryon, so as to introduce the latest R&D achievements of global life sciences into China and facilitate the availability of highly effective treatment options for Chinese patients, thereby contributing to building a healthy China.
By virtue of its solid independent R&D strength, successful experience of commercially developing global innovative drugs, and synergistic innovation philosophy rooted in corporate culture, Simcere has gained widespread recognition from its innovative pharmaceutical partners at home and abroad, and has been recognized by global pharmaceutical and biotechnology companies as the “Preferred Partner”.
Simcere website：
linkedIn：
https://www.linkedin.com/company/simcere-pharmaceutical-group
2021 Forbes report on Simcere:
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/