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Dr. Kevin Oliver, Senior Vice President and Global Head of Business Development and LicensingSuch competencies enable Simcere’s domestic and international clients to develop innovative drug candidates that fit the bill in meeting the industry’s shift toward personalized medicine. Notably, the company’s partners range from large, international big pharma to new and innovative startups, particularly in the U.S., Europe, and Asia Pacific region, whose 40 products are commercialized through a wide range of pharmacies. For instance, Simcere has more than 2100 class III hospital and 200 pharmacy chain tie-ups in China alone. “Even if a big pharma company based in U.S. or European desires to commercialize their product in China, they can do it seamlessly by partnering with Simcere. Therefore, we are an attractive partner of choice for domestic and international pharmaceutical companies and biotechnology companies.
Simcere’s full manufacturing capabilities range from active pharmaceutical ingredients (APIs) to 40 finished commercialized products with various dosage forms, each of which meets or exceeds the industry’s quality and regulatory requirements
Riding the coattails of such nimble R&D, commercialization, and supply chain capabilities, Simcere’s partners have shown exceptional outcomes. In one scenario, Simcere collaborated with G1 Therapeutics—a company specializing in developing and commercializing small molecule cancer therapeutics, such as CoselaTM (trilaciclib). The aim of this particular partnership was to file an Investigational New Drug (IND) application(s) in China within a certain time period to commercialize this product. Owing to the mutual trust with G1, Simcere had the clinical trial designs ready even before the completion of the formal agreement. This not only enabled Simcere to file the first IND of this candidate before the expected time but also helped Simcere streamline their succeeding IND approvals.
This is but one of the few success stories that Simcere has penned over the years. Having established itself as an exemplary global research and development-driven company and manufacturer over the last 26 years, Simcere is now looking at an ambitious future. In 1H2021 it invested over 29 percent of revenue back into R&D (compared to 9.9 percent in 2018) and generated 57 percent of revenue from innovative pharma products in 1H2021 (compared to 25 percent in 2018). Besides, Simcere also aims to become a preferred partner in innovative drug discovery and commercialization and has built an industry-leading BD&L and Alliance Management organization in 2020 and 2021 to ensure this is so. To ensure internal and external development success, the company will be extending its services to early-stage and clinical research for oncologic products and continue to build its team of over 900 scientists. Simcere, at the same time, is also poised to extend its global presence, partnering with pharma players in the U.S. and Europe to help develop and commercialize their products even outside China. The future, hence, seems bright for the company!
Company
Simcere
Management
Dr. Kevin Oliver, Senior Vice President and Global Head of Business Development and Licensing
Description
The name “Simcere” comes from the word “sincere,” which embodies treating people with sincerity. Simcere Pharmaceutical is rapidly transitioning innovation and an R&D-driven pharmaceutical company. Simcere focuses on three therapeutic areas: oncology, central nervous system diseases, and autoimmune diseases, with a diversified product portfolio and industry-leading capabilities. They also focus on oncology, central nervous system disease, and autoimmune disease therapeutic areas. The company has established R&D centers in Shanghai and Nanjing, China, and Boston, U.S. With the approval of the Ministry of Science and Technology, they have also established a National Key Laboratory of Translational Medicine and Innovative Pharmaceuticals.
Pursuant to the Agreement, Simcere obtains the exclusive rights in the development, manufacturing, and commercialization of Rademikibart for all indications in Greater China. Connect will retain its rights outside Greater China and will complete the ongoing pivotal clinical trial for atopic dermatitis (AD) treatment and other ongoing clinical trials. Simcere will independently conduct future clinical trials in Greater China.
According to Simcere's announcement, this collaboration will further enhance its product portfolio in the autoimmune field and strengthen the synergistic effect in its commercialization efforts.
Rademikibart (CBP-201) is a fully humanized monoclonal antibody and targets IL-4Rα, a common subunit of IL-4 receptor and IL-13 receptor, which is also the active target of the breakthrough therapy, Dupixent, which was approved by the U.S. Food and Drug Administration (FDA). By binding with IL-4Rα, Rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the Th2 inflammatory pathway and treating Th2 related inflammatory diseases, such as AD and asthma.
AD and asthma are both common chronic inflammatory diseases. According to Frost & Sullivan, the number of people living with AD has reached 649 million worldwide in 2019 and is expected to further increase to 755 million in 2030. Asthma had a global patient population of 746 million cases in 2019, and that number is expected to rise to 858 million in 2030.
Duplizumab (Dupixent) is the only IL-4Ra-targeting drug that was approved for marketing. It was jointly developed by Sanofi and Regeneron, and has been showing phenomenal market growth since its launch. According to Sanofi's half-year financial results announcement, Dupixent's global sales reached 4.878 billion euros (about 5.366 billion U.S. dollars) in the first half of 2023, and its full-year sales are expected to exceed 10 billion euros.
The market for IL-4Rα-targeting drugs is in the range of tens of billions of dollars. As one of the domestic forerunners, Rademikibart is being investigated both in the pivotal clinical trial for AD in China and phase II clinical trials for asthma in the world.
"We are very excited to have reached this agreement with Connect Biopharma. Rademikebart has demonstrated highly differentiated and best in class potential in Chinese AD patients. The addition of Rademikibart expands our immune diseases portfolio, where we can leverage our knowledge and expertise to advance its program and bring it to market," commented Jinsheng Ren, Chairman and CEO of Simcere. "We look forward to this collaboration and believe this partnership will help us bring better and more effective therapy to patients suffering from Th2 inflammatory diseases."
Simcere is an innovation and R&D-driven pharmaceutical company. The Company focuses on the therapeutic areas of oncology, CNS, autoimmune and anti-infection, with a forward-looking layout of 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". Driven by its in-house R&D efforts and synergistic innovation, the Company has established strategic cooperation partnerships with many innovative companies and research institutes.
Connect is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets.