Treatment of inflammatory diseases

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Connect Biopharma’s Exclusive Licensee in China, Simcere Pharmaceutical, Announced Submission of its New Drug Application for Rademikibart for the Treatment of Atopic Dermatitis in China
Globenewswire· 2025-07-09 13:00
Core Viewpoint - Connect Biopharma's collaborator, Simcere Pharmaceutical, has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China, indicating significant progress in the development of this potential best-in-class therapy for inflammatory diseases [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases, with rademikibart as its lead product candidate targeting IL-4Rα [6]. - Simcere Pharmaceutical is an R&D-driven company focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection [5]. Product Development - Rademikibart is a fully human monoclonal antibody that targets IL-4Rα, blocking the Th2 inflammatory pathway, which is relevant for treating atopic dermatitis and asthma [4]. - The AD market in China presents a considerable opportunity, with an estimated 70 million patients suffering from the condition [3]. Collaboration Agreement - In 2023, Connect Biopharma and Simcere entered an exclusive license and collaboration agreement for rademikibart in Greater China, granting Simcere exclusive rights for development, manufacturing, and commercialization [2][3]. - Connect Biopharma is eligible for milestone payments totaling approximately $110 million and tiered royalties on net sales in Greater China [3].