创新产品密集落地 在政策的赋能下，我国医疗器械企业的创新热情不断升温，多款创新产品密集获批落地，成为行业创新 活力的直接体现。 10月21日，国家药监局官网消息，由国家药监局南方医药经济研究所主办的"2025医疗器械经济信息发 布会"在合肥召开。会议指出，国家药监局将进一步完善法律标准体系，加大研发创新支持力度，提高 审评审批质效，全方位筑牢医疗器械高水平安全底线，加快创新产品上市步伐，促进医疗器械产业高质 量发展。 同日，北京海关发布的数据显示，今年前8个月，北京医疗仪器及器械出口58.3亿元，同比增长21.5%。 分析人士认为，医疗器械海外市场空间是国内的数倍，越来越多医疗器械企业实现了国际业务高增长。 国际化能力得到认可的公司，其估值也相应提升。 维力医疗主要从事麻醉、泌尿外科、护理、呼吸、血液透析等领域医疗器械的研发、生产和销售。维力 医疗日前发布的接待调研记录表显示，公司将继续以市场为导向，紧贴临床需求、加大研发投入、加快 新产品的研发，推动更多创新产品的快速上市；同时，加速推进海外印尼工厂的建设，积极推动海外本 土化进程，保障公司持续稳定健康的发展。 祥生医疗主营业务为超声医学影像设备研发、制造和 ...

10月21日，国家药监局官网消息，由国家药监局南方医药经济研究所主办的"2025医疗器械经济信息发 布会"在合肥召开。会议指出，国家药监局将进一步完善法律标准体系，加大研发创新支持力度，提高 审评审批质效，全方位筑牢医疗器械高水平安全底线，加快创新产品上市步伐，促进医疗器械产业高质 量发展。 同日，北京海关发布的数据显示，今年前8个月，北京医疗仪器及器械出口58.3亿元，同比增长21.5%。 分析人士认为，医疗器械海外市场空间是国内的数倍，越来越多医疗器械企业实现了国际业务高增长。 国际化能力得到认可的公司，其估值也相应提升。 ● 本报记者 傅苏颖 戴维医疗10月21日晚间公告，全资子公司维尔凯迪于近日收到浙江省药品监督管理局颁发的一次性使用 腔镜直线型切割吻合器及组件的医疗器械注册证。该产品用于腔镜下消化道重建及脏器切除手术中的残 端或切口的闭合。该产品医疗器械注册证的取得，有利于丰富公司产品线，进一步提高公司的核心竞争 力，对公司未来的经营成果将产生积极影响。 近日，已有部分医疗器械企业发布三季报。维力医疗10月20日晚间发布2025年三季报，公司第三季度营 业收入4.46亿元，同比增长16.09%；归母 ...

Core Viewpoint - The article highlights the recent approval of four innovative medical devices by the National Medical Products Administration in China, indicating a growing trend in the development and registration of innovative medical technologies in the country [1][8]. Group 1: Approved Products - The approved products include: 1. "Extended Depth of Focus Intraocular Lens" by Aibono Medical Technology Co., Ltd. [1] 2. "Cardiac Cryoablation Device" and "Single-use Sterile Cryoablation Probe" by Shenyang Pengyue Technology Co., Ltd. [1][8] 3. "Cross-linked Polyisobutylene Aspheric Intraocular Lens" by Xi'an Yandale Medical Technology Co., Ltd. [1][8] - As of now, a total of 373 innovative medical devices have been registered in China [1]. Group 2: Company Profiles - Aibono Medical Technology Co., Ltd. is an innovative ophthalmic medical device manufacturer listed on the Sci-Tech Innovation Board, focusing on cataract surgery, myopia control, and vision care solutions. The company reported a total revenue of 787 million yuan (approximately $114 million) with a year-on-year growth of 14.72% and a net profit of 213 million yuan (approximately $31 million) with a growth of 2.53% in the first half of 2025 [6]. - Shenyang Pengyue Technology Co., Ltd., established in 2020, specializes in digital intelligent precision medical fields and has developed a cardiac cryoablation system with independent intellectual property rights [10]. - Xi'an Yandale Medical Technology Co., Ltd. focuses on intraocular lenses for cataract treatment and is led by a team of experts, including members from the American Academy of Engineering [18]. Group 3: Product Details - The "Extended Depth of Focus Intraocular Lens" is designed for vision correction after cataract surgery, featuring a one-piece, foldable design made from a combination of ethyl acrylate and methyl methacrylate [5]. - The "Cardiac Cryoablation Device" is used for treating persistent atrial fibrillation in adult patients, utilizing argon gas for rapid cooling of myocardial cells [9]. - The "Cross-linked Polyisobutylene Aspheric Intraocular Lens" is notable for its high refractive index and is designed for implantation through a small incision, providing an improved visual experience for cataract patients [15].

Macro Strategy - The LPR remained unchanged in September, with the 1-year and 5-year rates at 3.00% and 3.50% respectively, reflecting a stable monetary policy in China [3] - A-shares experienced a high-level fluctuation with the Shenzhen Component Index rising by 1.06% and the ChiNext Index increasing by 1.96% during the week of September 22-26, 2025, driven by positive market sentiment and expectations of favorable policies [4] Industry Overview - The semiconductor and wind power equipment sectors showed strong performance with weekly increases of 7.64% and 6.00% respectively, while the tourism and hotel sectors faced declines of -11.65% and -8.38% [6] - The communication equipment and components sectors have seen cumulative gains of 95.45% and 91.96% respectively since the beginning of 2025 [6] North Exchange Market - As of September 26, 2025, the North Exchange had 277 listed stocks, with an average total market value of 883.56 billion, a decrease of 4.14% from the previous week [9] - The liquidity in the North Exchange decreased, with average trading volume dropping by 20.67% to 9.10 billion shares [11] New Materials Industry - The rare earth magnetic materials sector declined by 1.54% this week, underperforming the benchmark [15] - Prices for rare earth minerals continued to adjust, with mixed carbonated rare earth ore prices falling by 2.63% to 3.57% [16] Medical Consumables Industry - Aibo Medical's extended depth of focus intraocular lens received approval, indicating growth potential in the high-end segment of the artificial lens market driven by an aging population [21] - The market for high-value consumables is expected to benefit from recent policy changes and the ongoing demand for diverse medical supplies [24]

Market Strategy - The market trading activity is decreasing ahead of the holiday, suggesting a shift towards defensive strategies [5][9] - The overall A-share market saw a decline of 1.20%, with the Shanghai Composite Index down 0.65% and the ChiNext Index down 2.60% [7][8] - The market is expected to remain volatile as investors seek to avoid uncertainties before the holiday, with potential for capital to flow back into the market post-holiday if no major risks arise [9] Economic Insights - The People's Bank of China conducted a 7-day reverse repurchase operation of 181.7 billion yuan, indicating liquidity management efforts [15][16] - From January to August, profits of large-scale industrial enterprises increased by 0.9% year-on-year, with significant growth in August at 20.4% [17][18] Industry Dynamics - In October, China's battery production is projected to reach 186 GWh, marking a month-on-month increase of 22.4% and a year-on-year increase of 45.3% [28][29] - The offshore wind power project in Hainan is set to procure 600 MW of wind turbine equipment, highlighting ongoing investments in renewable energy [32][33] - The completion of submarine cable laying for the Qingzhou offshore wind farm marks a significant advancement in offshore wind energy infrastructure [34] Company Updates - Meikang Bio (300439.SZ) received a medical device registration certificate for its anti-Xa testing kit, indicating progress in its product offerings [36] - Aibo Medical (688050.SH) has received approval for its extended focus artificial lens, enhancing its product portfolio in the medical device sector [38] - Mingyang Smart Energy (601615.SH) successfully tested over 1,300 offshore wind turbines against Typhoon "Haikasa," demonstrating the resilience of its technology [39]

Core Viewpoint - Aibo Medical has received approval from the National Medical Products Administration for its "Extended Focus Artificial Lens" through the special review for innovative medical devices [2] Company Summary - Aibo Medical announced the registration approval of its "Extended Focus Artificial Lens" [2] Industry Summary - The approval signifies a positive development in the medical device sector, particularly in innovative ophthalmic solutions [2]

Group 1 - The National Development and Reform Commission (NDRC) is accelerating the construction of a nationwide integrated computing power network, aiming to create a new type of infrastructure that integrates computing power coordination, monitoring, unified scheduling, elastic supply, and security assurance [2][3] - Six departments have jointly issued measures to strengthen the cultivation of innovative digital economy enterprises, encouraging financial institutions to provide market-oriented financial services tailored to the needs of digital economy enterprises [3][4] - The CEO of Yushutech announced that the company will release a 1.8-meter humanoid robot in the second half of the year, highlighting significant growth in the domestic robotics industry, with an average growth rate of 50% to 100% among related companies [6][7] Group 2 - The implementation opinions on "Artificial Intelligence + Transportation" have been released, promoting the development of intelligent driving systems, remote driving cockpits, and new equipment such as drones and all-terrain vehicles [4] - The IPO application of Moer Thread has been approved by the Shanghai Stock Exchange, with plans to raise 8 billion yuan for the development of new AI training and graphics chips [8] - The company Hush Silicon Industry has received approval from the China Securities Regulatory Commission for a share issuance and cash payment to purchase assets, with a fundraising cap of 21.05 billion yuan [10]

Core Viewpoint - Aibo Medical has received approval from the National Medical Products Administration for its "Extended Depth of Focus Intraocular Lens," marking a significant advancement in high-end refractive intraocular lenses for cataract surgery [1] Company Summary - Aibo Medical's new product is designed for vision correction in adults who have undergone cataract surgery and have no natural lens [1] - The lens utilizes advanced aspheric design to extend the depth of focus, improving intermediate vision while maintaining distance vision [1] - The product aims to reduce dependency on glasses for patients post-surgery [1]

Core Viewpoint - Aibo Medical has received approval from the National Medical Products Administration for its "Extended Depth of Focus Intraocular Lens," marking a significant advancement in high-end refractive intraocular lenses for vision correction post-cataract surgery [1]. Company Summary - Aibo Medical's new product is designed for adults who have undergone cataract surgery and have no natural lens, aiming to improve intermediate vision while maintaining distance vision [1]. - The lens utilizes advanced aspheric design to enhance depth of focus without significantly compromising distance vision, thereby reducing dependence on glasses [1].

Core Viewpoint - Aibo Medical (688050.SH) has received approval from the National Medical Products Administration for its "Extended Depth of Focus Intraocular Lens," marking a significant advancement in its product offerings [1] Company Summary - The "Extended Depth of Focus Intraocular Lens" is categorized as a high-end refractive intraocular lens, designed for vision correction in adults who have undergone cataract surgery and have no natural lens [1] - The product utilizes advanced aspheric design to extend the depth of focus, improving intermediate vision while maintaining distance vision without significantly reducing it, thereby decreasing reliance on glasses [1]