February 25, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that the marketing application for Mandocizab injection, a Class 1 new drug independently developed by Akeso Biopharma, has been accepted. This novel humanized monoclonal antibody targeting IL-4Rα is used to treat moderate to severe atopic dermatitis (AD), marking another important milestone in the company's autoimmune pipeline.
Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease with the highest socioeconomic burden among dermatological diseases. According to relevant information, there are at least 230 million AD patients worldwide, with approximately 19.6 million moderate to severe AD patients in China in 2022, and this number is projected to increase to 22.8 million by 2030. With the widespread application of biologics, the market size for AD biologics is expected to grow rapidly. The application for marketing approval of mandozizumab is based on positive results from its pivotal registrational Phase III clinical trial. This study showed that mandozizumab achieved statistically significant and clinically meaningful improvements on the primary endpoint, key secondary endpoints, and several other pre-specified secondary endpoints. The drug significantly improved the skin lesions in patients and demonstrated excellent efficacy in improving early pruritus.
Mandozymeab is Akeso's fourth non-oncology drug to enter the NDA application stage. Its mechanism of action involves specifically binding to IL-4Rα, blocking the IL-4 and IL-13-mediated signaling pathway, thereby inhibiting related immune inflammatory responses. The IL-4Rα monoclonal antibody market has enormous potential; the world's first drug targeting the same target, dupilumab, is projected to have global sales exceeding 200 billion RMB in 2024.
Currently, two IL-4Rα monoclonal antibodies are available in China: spritzimab from Cannoya/CSPC Pharmaceutical Group and dupilumab from Regeneron/Sanofi. The marketing application for lendroximab from Connecticut/Simcere Pharmaceutical is also under review. The addition of mandozimab will further enrich the selection of domestically produced innovative biologics, providing Chinese patients with a highly effective, safe, and affordable new treatment option.

https://news.yaozh.com/archive/47276.html