Meiwei Biotechnology: The application for the marketing authorization of 9MW0813 injection has been accepted.

Maiwe Bio announced that the company has received the "Acceptance Notice" issued by the National Medical Products Administration, and the marketing authorization application for 9MW0813 injection has been accepted for the treatment of diabetic macular edema and neovascular age-related macular degeneration. 9MW0813 injection is a biosimilar of aflibercept intraocular injection solution, which has undergone comparative studies such as quality optimization through multi-batch process comparison, head-to-head quality research, structural characterization, functional studies, and stability tests, proving the stability and quality controllability of the production process of 9MW0813, and its high consistency with Eylea in pharmaceutical aspects. Due to the long research and development cycle of drugs and multiple approval processes, there is uncertainty about whether this marketing authorization application will be approved. In addition, the company has reached a supply and commercialization agreement with an Indian pharmaceutical company, granting the exclusive rights for the import, production, registration, marketing, and sale of 9MW0813 in India.