Simcere and Connect ink exclusive deal for autoimmune drug Rademikibart.

24 November 2023 | Friday | News

Simcere Pharmaceutical Group Limited ("Simcere") entered into an exclusive license and collaboration agreement (the "Agreement") with Connect Biopharma HongKong Limited ("Connect") in relation to Rademikibart, an innovative IL-4Rα monoclonal antibody.

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.


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