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
SAN DIEGO, July 09, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma", "Connect", or the "Company"), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that the Company's collaborator and exclusive licensee in China, Simcere Pharmaceutical Co., Ltd. ("Simcere"), has submitted its New Drug Application for rademikibart to the National Medical Products Administration of China ("NMPA") for the treatment of atopic dermatitis ("AD") in adults and adolescents.
"Simcere continues to make strong progress in advancing rademikibart in China, our potentially best in class next generation IL-4Rα antibody," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "Atopic dermatitis remains a large and growing market in China, and rademikibart has the potential to significantly improve the condition for millions of patients. Together, we remain committed to advancing rademikibart for the treatment of a range of inflammatory diseases including AD, asthma, and chronic obstructive pulmonary disease."
In 2023, Connect and Simcere entered into an exclusive license and collaboration agreement for rademikibart in China. Under the agreement, Simcere was granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect retains rights in all other markets.
As part of the agreement, Connect is eligible to receive milestone payments up to an aggregate remaining amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD.
About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). By binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma.
About Simcere
Simcere Pharmaceutical Co., Ltd. is an innovation and R&D-driven pharmaceutical company and focuses on the therapeutic areas including neuroscience, anti-oncology, autoimmune and anti-infection. The company develops innovative therapies in 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, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.
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. The Company's lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target IL-4Rα and has demonstrated activity in both atopic dermatitis and asthma. The Company is currently conducting global studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need.
For more information visit www.connectbiopharm.com.
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This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.
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