赛诺医疗:子公司COMETIU支架产品注册申请未获国家药监局批准

Core Viewpoint - Sino Medical (688108) announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., received a notification from the National Medical Products Administration (NMPA) stating that the registration application for its COMETIU self-expanding intracranial drug-coated stent system was not approved [1] Group 1 - The COMETIU stent's registration application was publicly disclosed as not approved by the NMPA on October 28 [1] - The company stated that the lack of domestic registration approval for the COMETIU stent will not have a short-term impact on its production and operations [1] - The company will continuously assess the long-term impact of the registration denial and will proceed with clinical, registration, and commercialization processes for the COMETIU stent in domestic, European, American, and global markets [1]