COMETIU支架
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盘前必读丨“十五五”规划建议发布;美股续创历史新高
Di Yi Cai Jing Zi Xun· 2025-10-29 00:04
Group 1 - The U.S. stock indices reached new historical highs, driven by Nvidia's strong rebound and investor optimism regarding tech giants' earnings outlook [2] - Nvidia's stock rose by 4.98%, approaching a market capitalization of $5 trillion, while Microsoft increased by approximately 2% to regain a $4 trillion market cap [2] - In the commodities market, international oil prices continued to decline, with WTI crude oil futures falling by 1.89% to $60.15 per barrel, and Brent crude oil futures down by 1.65% to $63.83 [2] Group 2 - The Chinese government is committed to expanding high-level financial openness and welcomes foreign financial institutions and long-term capital to invest in China [3] - The People's Bank of China emphasized the need for a moderately loose monetary policy to support economic recovery and ensure that social financing and money supply growth align with economic growth targets [4] - The National Postal Administration has urged Zhongtong Express to improve service quality and comply with regulations after identifying issues with operational practices [4] Group 3 - The 11th batch of national drug centralized procurement included 55 commonly used medicines, achieving goals of stabilizing clinical use and ensuring quality [6] - Microsoft signed a new agreement with OpenAI for an additional $250 billion in Azure services, while also supporting the establishment of a public benefit company [6] - Nokia's board approved a directed share issue to allow Nvidia to invest $1 billion, resulting in Nvidia acquiring a 2.9% stake in Nokia at a subscription price of $6.01 per share [6] Group 4 - Companies like China Ping An reported a net profit of 132.86 billion yuan for the first three quarters, a year-on-year increase of 11.5% [7] - TCL Zhonghuan reported a net loss of 5.78 billion yuan for the first three quarters, while companies like Shengyi Electronics and Ganfeng Lithium saw significant profit increases of 545.95% and 364.02% respectively [7] - The market is expected to experience increased volatility in the next 1-3 months, with a focus on substantial earnings growth post-third quarter reports [8]
赛诺医疗(688108.SH):子公司产品COMETIU支架国内注册未获批准
智通财经网· 2025-10-28 17:54
Core Viewpoint - Sino Medical (688108.SH) announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., received a "medical device registration not approved" notice from the National Medical Products Administration (NMPA) for its COMETIU self-expanding intracranial drug-coated stent system [1] Group 1: Regulatory Approvals - The COMETIU stent's registration application was not approved by the NMPA, and the results have been publicly disclosed [1] - The company submitted an EU MDR certification application for the COMETIU stent to DEKRA Certification B.V. in October 2024, which has been accepted, and the product is currently in the final stage of technical review after passing the on-site quality system audit [1] Group 2: FDA Recognition - The COMETIU stent and COMEX balloon microcatheter received breakthrough medical device designation from the FDA in August 2025 [1] - This product is the first intracranial atherosclerotic stenosis treatment device to receive breakthrough designation in the history of the FDA's program and is also the first neuro-interventional device from China to achieve this recognition [1]