Connect Biopharma's rademikibart NDA submitted in China for atopic dermatitis

Connect Biopharma Holdings (NASDAQ:CNTB), a clinical-stage biopharmaceutical company dedicated to transforming care for inflammatory diseases, today announced that its collaborator and exclusive Chinese licensee, Simcere Pharmaceutical Co., has submitted a New Drug Application (NDA) for rademikibart to the National Medical Products Administration (NMPA) of China.

The application seeks approval for rademikibart as a treatment for atopic dermatitis (AD) in adults and adolescents.

Rademikibart is described by Connect Biopharma as a potentially best-in-class, next-generation IL-4Rα antibody.

"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."

The collaboration between Connect Biopharma and Simcere Pharmaceutical began in 2023 with an exclusive license and collaboration agreement for rademikibart in China.

Under the terms of this agreement, Simcere holds exclusive rights for the development, manufacturing, and commercialization of rademikibart across all indications within Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan.

Connect Biopharma retains all rights for other global markets.

Under the agreement, Connect Biopharma stands to receive an aggregate remaining amount of approximately $110 million in milestone payments upon the achievement of specific development, regulatory, and commercial milestones.

Additionally, Connect is eligible for tiered royalty payments on net sales in Greater China, with rates reaching up to low double-digit percentages.

The atopic dermatitis market in China presents a significant opportunity, with an estimated 70 million patients affected by the condition.