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Yahong Pharmaceuticals: APL-1702 Marketing Authorization Application Accepted by the European Medicines Agency
Aiyang BioPharmaceuticals announcement. Recently, the Company has received a notice from the European Medicines Agency (EMA). The marketing authorization application for the Company’s product APL-1702 (CEVIRA) for the treatment of patients with high-grade squamous intraepithelial lesions (HSIL) of the cervix has been accepted by the EMA. After the marketing authorization application is accepted, the product still needs to go through subsequent review and approval processes, so there is uncertainty as to whether it will be successfully brought to market and the specific timeline for its launch. Even after approval, there is also some uncertainty as to whether it can ultimately achieve its commercial objectives. The above acceptance of the marketing authorization application will not have a material impact on the Company’s near-term performance.