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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.
Posted In: CNTB