Pharmaceutical Business review

Simcere Pharmaceutical seeks China approval for atopic dermatitis treatment

Under the partnership agreement, Connect Biopharma will receive up to approximately $110m. Credit: Paul Zoetemeijer on Unsplash.

This application aims to secure approval for treating adult and adolescent atopic dermatitis (AD).

Under the partnership agreement, Connect Biopharma will receive up to approximately $110m in milestone payments conditional on reaching specific developmental, regulatory and commercial targets.

Additionally, it is expected to earn royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China

Connect Biopharma CEO and director Barry Quart said: “Simcere continues to make strong progress in advancing rademikibart in China, our potentially best in class next generation IL-4Rα antibody.

“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, an exclusive license and collaboration agreement was established between Connect and Simcere, granting Simcere exclusive rights within Greater China including mainland China, Hong Kong, Macau, and Taiwan, for the development, manufacturing, and commercialisation of rademikibart. Meanwhile, Connect retains rights in all other markets.

Rademikibart is a fully human monoclonal antibody that specifically targets the interleukin-4 receptor alpha (IL-4Rα), a shared subunit of both the interleukin-4 (IL-4) and interleukin-13 (IL-13) receptors. By binding to IL-4Rα, rademikibart effectively inhibits the actions of IL-4 and IL-13, thereby disrupting the T helper 2 (Th2) inflammatory pathway. This mechanism makes it a promising treatment option for Th2-related inflammatory conditions, including atopic dermatitis and asthma.