Photocure ASA has announced that its associate, Asieris Pharmaceuticals, has been informed that the National Medical Products Administration (NMPA) has approved its new drug application or NDA for regulatory review. The drug under review, Cevira (APL-1702, Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System), is being considered for potential marketing authorization in China.
Cevira (APL-1702) is a photodynamic drug-device combination product. It is currently in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL). The product has been licensed to Asieris by Photocure.
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