Connect Biopharma Partners with Simcere for Rademikibart Development in Greater China
Key Insights
Connect Biopharma (search) and Simcere announced an exclusive licensing agreement granting Simcere rights to develop and commercialize rademikibart, an IL-4Rα (search) monoclonal antibody, for all indications in Greater China.
The deal includes a ¥150 million RMB upfront payment and up to ¥875 million RMB in milestone payments, with Connect Biopharma (search) retaining global rights outside Greater China.
Rademikibart targets IL-4Rα (search) to block Th2 inflammatory pathways and is currently in pivotal trials for atopic dermatitis (search), with a new drug application planned for China by Q1 2024.
Connect Biopharma (search) Holdings Limited and Simcere Pharmaceutical Group (search) Limited announced on November 21, 2023, an exclusive licensing and collaboration agreement for rademikibart, a fully humanized monoclonal antibody targeting IL-4Rα (search). The partnership grants Simcere exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, while Connect Biopharma retains rights in all other global markets.
Financial Terms and Structure
Under the agreement, Connect Biopharma (search) will receive a ¥150 million RMB (US$ 21 million) upfront payment, with potential milestone payments reaching up to ¥875 million RMB (US$ 120 million) upon achieving certain development and commercial milestones. Additionally, Connect Biopharma will receive royalties up to low double-digit percentages of net sales.
Connect Biopharma (search) will complete all ongoing China clinical trials and related analysis in atopic dermatitis (search), with a new drug application submission for AD in China targeted by the end of Q1 2024. Simcere will assume responsibility for the new drug application for AD in China and will conduct and fund all future clinical studies for additional disease indications in Greater China.
Rademikibart's Mechanism and Development Status
Rademikibart (CBP-201) is a fully humanized monoclonal antibody that targets IL-4Rα (search), a common subunit of IL-4 (search) receptor and IL-13 (search) receptor. By binding with IL-4Rα, rademikibart blocks the functions of IL-4 and IL-13, thereby inhibiting the Th2 inflammatory pathway and treating Th2-related inflammatory diseases such as atopic dermatitis (search) and asthma (search).
The drug is currently being tested in pivotal clinical trials for atopic dermatitis (search) in China and phase II clinical trials for asthma (search). According to Connect Biopharma (search)'s CEO Zheng Wei, the drug has demonstrated "strong long-term efficacy and safety top-line data from the rademikibart China pivotal trial in AD."
Strategic Rationale and Portfolio Synergies
"Rademikibart has demonstrated a highly-differentiated every-four-weeks dosing regimen in AD and a best-in-class potential in Chinese AD patients," commented Jinsheng Ren, Chairman and CEO of Simcere. "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."
The collaboration enhances Simcere's existing autoimmune portfolio, which includes Iremod®, the world's first iguratimod tablets. The company's pipeline also features SIM0278, an interleukin-2 mutant Fc fusion protein that entered clinical studies in China in August 2023, with overseas development partner Almirall receiving FDA approval for U.S. clinical studies. Additionally, Simcere's JAK1 (search) inhibitor LNK01001, developed in cooperation with Lynk Pharmaceuticals (search), has shown positive phase II clinical trial data in rheumatoid arthritis (search) and ankylosing spondylitis (search).
Company Positioning and Expertise
Connect Biopharma (search) CEO Zheng Wei emphasized Simcere's qualifications as a partner: "Simcere is a leading pharmaceutical company in China with an extensive partnership track record and proven capabilities in regulatory affairs, manufacturing, clinical operations, and commercialization. We believe they are the ideal partner to advance the rademikibart program in Greater China and to provide patients with a potentially more efficacious treatment and a more convenient dosing regimen."
Connect Biopharma (search) is a global clinical-stage biopharmaceutical company that applies expertise in T cell biology to develop innovative therapies for chronic inflammatory diseases. The company builds its pipeline using functional T cell assays to screen and discover product candidates against validated immune targets.
Simcere Pharmaceutical Group (search) Limited is an innovation and R&D-driven pharmaceutical company that has established a "State Key Laboratory of Neurology and Oncology Drug Development." The company focuses on oncology, nervous system, autoimmune, and anti-infection therapeutic areas, with strategic cooperation partnerships across multiple innovative companies and research institutes.