本次独道获得NMPA批准，是本集团引领全球手术机器人领域技术与应用发展的里程碑式突破，也标志 着国产手术机器人在微无创诊疗关键技术路径上实现系统性全覆盖。至此，本集团在手术机器人领域获 批上市的产品数量增至7 款，成为全球首家、也是目前唯一一家实现手术机器人"五大黄金赛道"全赛道 产品商业化上市的企业。 据介绍，最新获批的独道是一个无创经自然腔道机器人手术平台，其具有超柔顺，超纤细蛇形机器人导 管，可通过人体自然腔道，以无体表创伤的方式进入难以触及的狭窄病灶空间，对肺部微小结节等癌症 早期病变的早诊早治具有重要意义。 微创机器人-B（02252）早盘股价大涨13.58%，现报24.08港元，成交额1.09亿港元。 12月24日，微创机器人-B发布公告，由本集团自主研发的支气管镜手术机器人独道®UniPathTM电子支 气管镜手术导航系统（独道）正式获得国家药品监督管理局（NMPA）批准。 来源：新浪港股 ...

本次独道获得NMPA批准，是本集团引领全球手术机器人领域技术与应用发展的里程碑式突破，也标志 着国产手术机器人在微无创诊疗关键技术路径上实现系统性全覆盖。至此，本集团在手术机器人领域获 批上市的产品数量增至7款，成为全球首家、也是目前唯一一家实现手术机器人"五大黄金赛道"全赛道 产品商业化上市的企业。 据介绍，最新获批的独道是一个无创经自然腔道机器人手术平台，其具有超柔顺，超纤细蛇形机器人导 管，可通过人体自然腔道，以无体表创伤的方式进入难以触及的狭窄病灶空间，对肺部微小结节等癌症 早期病变的早诊早治具有重要意义。 微创机器人-B(02252)涨超7%，截至发稿，涨7.64%，报22.58港元，成交额2045.01万港元。 消息面上，12月24日，微创机器人-B发布公告，由本集团自主研发的支气管镜手术机器人独道 UniPathTM电子支气管镜手术导航系统(独道)正式获得国家药品监督管理局(NMPA)批准。 ...

智通财经APP获悉，微创机器人-B(02252)涨超7%，截至发稿，涨7.64%，报22.58港元，成交额2045.01 万港元。 消息面上，12月24日，微创机器人-B发布公告，由本集团自主研发的支气管镜手术机器人独道 ®UniPathTM电子支气管镜手术导航系统(独道)正式获得国家药品监督管理局(NMPA)批准。 本次独道获得NMPA批准，是本集团引领全球手术机器人领域技术与应用发展的里程碑式突破，也标志 着国产手术机器人在微无创诊疗关键技术路径上实现系统性全覆盖。至此，本集团在手术机器人领域获 批上市的产品数量增至7 款，成为全球首家、也是目前唯一一家实现手术机器人"五大黄金赛道"全赛道 产品商业化上市的企业。 据介绍，最新获批的独道是一个无创经自然腔道机器人手术平台，其具有超柔顺，超纤细蛇形机器人导 管，可通过人体自然腔道，以无体表创伤的方式进入难以触及的狭窄病灶空间，对肺部微小结节等癌症 早期病变的早诊早治具有重要意义。 ...

Core Viewpoint - The company has submitted a CE certification application for its transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Development - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device incorporates a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure [1] - The integrated detachment design aims to reduce potential operational risks during the detachment process, effectively shortening the operational time [1] Group 2: Clinical and Regulatory Progress - The one-year clinical follow-up results and challenging case applications of JensClip have been presented at major international academic conferences, demonstrating excellent safety and efficacy indicators [1] - The product has completed the registration application submission to the National Medical Products Administration in China and is currently under review [2] - JensClip has successfully commenced clinical applications overseas, with the company actively promoting the registration process to meet broad clinical needs [2]

Group 1 - Current demand for silver from investors and industries is extremely high, with both physical and financial assets being accumulated for wealth storage and hedging against risks associated with the US dollar and other currencies [1] - The solar industry consumes nearly 30% of the annual silver production from mining and recycling, while the supply side shows little potential for significant new production due to the depletion of "pure silver" deposits [2] - The price of precious metals, including silver, is at risk of a correction, as indicated by the announcement from Guotai Junan UBS Silver Futures Securities Investment Fund regarding the suspension of subscriptions for certain fund shares starting December 29, 2025 [3] Group 2 - On December 29, spot silver prices surged nearly 6%, approaching the $84 mark, setting a new historical high before slightly retreating to $83.2 per ounce [4] - To mitigate market risks, the Shanghai Futures Exchange issued notifications on December 26, advising the market to implement risk control measures and outlining trading margin ratios and price fluctuation limits for related products during the New Year period [5]

Regulatory Developments - The National Medical Products Administration (NMPA) held a meeting on post-market regulation of medical devices, emphasizing the need for a balance between safety and industry vitality while planning for 2026 [1] - The NMPA approved the long-acting growth hormone injection, Nozeyou®, developed by Novo Nordisk, marking it as the first international original long-acting growth hormone for children in China [4] - Changchun High-tech's subsidiary, GenSci, received acceptance for a clinical trial application for GenSci141 ointment, which aims to address various hormonal deficiencies in children [5] - Jiukang Bio announced the acquisition of medical device registration certificates for two diagnostic kits, enhancing its product line in the in vitro diagnostic sector [6] Market Activities - Suzhou Tongxin Medical Technology's IPO application was accepted, with plans to raise 1.064 billion yuan for various projects including the production base for implantable left ventricular assist devices [8][9] - Zhendong Pharmaceutical announced a partnership to establish a fund focused on investments in the biopharmaceutical sector, contributing 30 million yuan as a limited partner [11] Corporate Changes - Baihua Pharmaceutical is planning a change in control, leading to a temporary suspension of its stock trading [10] - *ST Changyao is under investigation for alleged financial misconduct, which may lead to a forced delisting due to false financial reporting [18]

Core Viewpoint - The company has submitted a CE certification application for its innovative transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Overview - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device includes a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the operational time [1] Group 2: Clinical and Regulatory Progress - The one-year clinical follow-up results and challenging case applications of JensClip have been presented at major international conferences, demonstrating excellent safety and efficacy indicators [1] - In China, the product has completed the submission of its registration application to the National Medical Products Administration and is currently under review [2] - JensClip has successfully commenced clinical applications overseas, with the company actively promoting the registration process to meet broad clinical needs [2]

Core Viewpoint - The company has submitted a CE certification application for its innovative transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1] Group 1: Product Development - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device incorporates a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure and improving operational convenience [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the device operation time [1] - JensClip's innovative design has been patented globally [1] Group 2: Clinical Trials and Regulatory Progress - One-year clinical follow-up results and challenging case applications of JensClip have been presented at international academic conferences such as EuroPCR, TCT San Francisco, and PCR London Valves, demonstrating excellent safety and efficacy indicators [2] - The product has completed the submission of its registration application to the National Medical Products Administration in China and has received acceptance, currently undergoing the registration review phase [2] - JensClip has successfully commenced clinical applications overseas, and the company is actively promoting the product's registration process to meet widespread clinical needs [2]

Group 1 - The current demand for silver from investors and the industrial sector is extremely high, with both physical and financial assets being accumulated for wealth storage and as a hedge against risks associated with the US dollar and other currencies [3][4] - In the real economy, the demand for silver is robust, particularly from jewelry manufacturers, medical device producers, electric vehicle manufacturers, data center construction companies, and notably, solar panel manufacturers [3][4] - Citigroup analysts estimate that the solar industry consumes nearly 30% of the annual silver production from mining and recycling [3][4] Group 2 - There is little possibility of significant new silver supply entering the market, as global "pure silver" deposits are nearly exhausted, with most silver now being produced as a byproduct of mining other metals like copper, gold, and zinc [3][4] - John Ciampaglia, CEO of Sprott Asset Management, indicates that changes in silver supply are often driven by the demand for other metals rather than silver itself [3][4] - There are warnings that precious metal prices are at a "cliff edge," with accumulating risks of a price correction [3][4]

Group 1 - The current demand for silver from both investors and the industrial sector is extremely high, with silver being accumulated in both physical and financial asset forms for wealth storage and as a hedge against risks associated with the US dollar and other currencies [3] - The jewelry industry, medical device manufacturers, electric vehicle producers, data center construction companies, and especially solar panel manufacturers are major consumers of silver [3] - Citigroup analysts estimate that the solar industry consumes nearly 30% of the annual silver production from mining and recycling [4] Group 2 - There is little possibility of significant new silver production entering the market, as global "pure silver" deposits are nearly exhausted, with most silver now being produced as a byproduct of mining other metals like copper, gold, and zinc [4] - Changes in silver supply are often driven by the demand for other metals rather than silver itself, according to John Ciampaglia, CEO of Sprott Asset Management [4] - Some analysts warn that precious metal prices are at a "cliff edge," indicating that the risk of a price correction is accumulating [5]