Connect Biopharma’s partner submits new drug application in China

SAN DIEGO - Connect Biopharma Holdings Limited (NASDAQ:CNTB), a biotech company with a market capitalization of $63 million and a strong financial health rating according to InvestingPro, announced Wednesday that its collaborator Simcere Pharmaceutical has submitted a New Drug Application for rademikibart to China’s National Medical Products Administration for treating atopic dermatitis in adults and adolescents.

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha, which blocks the functions of IL-4 and IL-13, thereby inhibiting the T helper 2 inflammatory pathway associated with conditions like atopic dermatitis and asthma.

The application marks progress in the companies’ partnership established in 2023, when Connect granted Simcere exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, while retaining rights in other markets.

Under the agreement, Connect remains eligible to receive milestone payments up to approximately $110 million upon reaching certain development, regulatory and commercial targets, plus tiered royalties up to low double-digit percentages on net sales in Greater China.

"Simcere continues to make strong progress in advancing rademikibart in China," said Barry Quart, CEO of Connect Biopharma, according to the press release statement.

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

Connect Biopharma is currently conducting global studies of rademikibart for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease.

The drug candidate has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or any other regulatory agency.

In other recent news, Connect Biopharma Holdings Limited has reported positive clinical data for its experimental antibody, rademikibart, in treating eosinophilic-driven type 2 asthma. The data, presented at a major European congress, showed significant improvements in lung function and reductions in asthma exacerbations over a 24-week period. Connect Biopharma’s Phase 2b trial indicated a reduction in annualized asthma exacerbation rates by up to 74% in patients with specific inflammatory markers. Additionally, the company has commenced its Phase 2 Seabreeze STAT Asthma study, which will evaluate the safety and efficacy of rademikibart as an add-on therapy for acute asthma exacerbations. This study, approved by the U.S. Food and Drug Administration, aims to enroll around 160 participants globally. The company anticipates reporting topline data from this study in the first half of 2026. Connect Biopharma is conducting ongoing research to address unmet needs in asthma and chronic obstructive pulmonary disease care.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.