On July 08, 2025, the new drug application (NDA) of the innovative drug Rademikibart, jointly developed by the Simcere（2096.HK） and Connect Biopharma, was accepted by the National Medical Products Administration (NMPA) for the treatment of atopic dermatitis.
Atopic dermatitis is a chronic inflammatory, recurrent skin disease characterized by dry skin, severe itching and eczema. It can also be accompanied by chronic diseases such as asthma, allergic rhinitis and insomnia, which significantly affects the quality of life of patients. It is estimated that the number of patients currently suffering from atopic dermatitis in China is about 70 million, and is still increasing.
Rademikibart is a fully human monoclonal antibody targeting IL-4Rα, a common subunit of IL-4 receptor and IL-13 eceptor. By binding with IL-4Rα, Rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the Th2 inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma.
About Connect Biopharma
Connect Biopharma is a global, clinical-stage biopharmaceutical company dedicated to developing innovative therapies and transforming care for the treatment of inflammatory diseases. Connect Biopharma’s lead product candidate, Rademikibart (formerly known as CBP-201), is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and has demonstrated activity in both atopic dermatitis and asthma. Connect Biopharma is currently conducting global studies of Rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet needs.
About Simcere
Simcere Pharmaceutical group is an innovation and R&D-driven pharmaceutical company and has established a “State Key Laboratory of Neurology and Oncology Drug Development”. The Company focuses on the therapeutic areas of neuroscience, anti-oncology, autoimmune and anti-infection, with forward-looking layout of disease areas that may have significant clinical needs in the future, aiming to achieve the mission of “for patients, for life”. 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.