赛诺医疗：子公司产品国内注册未获批，海外进展积极

Core Viewpoint - Sino Medical announced that its subsidiary, Sino Shenchang, received a "medical device registration not approved" notice from the National Medical Products Administration for its COMETIU self-expanding intracranial drug-coated stent system, which was not approved for domestic registration. However, the product is making positive progress overseas, having passed the EU MDR on-site quality system audit and is in the final stage of technical review. It has also received breakthrough medical device designation from the FDA, allowing it to directly conduct pivotal confirmatory clinical studies. The company will advance its global commercialization, and the domestic registration denial will not have a short-term impact on production and operations [1]. Summary by Category Product Development - The COMETIU self-expanding intracranial drug-coated stent system did not receive domestic registration approval from the National Medical Products Administration [1] - The product has successfully passed the EU MDR on-site quality system audit and is in the final stage of technical review [1] - The product has received breakthrough medical device designation from the FDA, enabling the company to conduct pivotal confirmatory clinical studies directly [1] Business Impact - The company plans to push forward with global commercialization of the product [1] - The denial of domestic registration is not expected to impact production and operations in the short term [1]