Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received registration approval from the National Medical Products Administration of China for its controllable mechanical embolization spring coil, which is designed for peripheral vascular applications [1] Group 1: Product Details - The product is intended for the embolization of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas [1] - It features a controllable release mechanism that ensures a stable and precise deployment of the spring coil, enhancing operational control and safety [1] - The product is available in both 2D and 3D structures, allowing for broad adaptability to clinical needs [1] Group 2: Market Strategy - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

Acotec Scientific Holdings Limited 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 本公司董事會（「董事會」）欣然宣佈，於2025年8月22日，本集團收到中國國家藥 品監督管理局對外周可控機械解脫帶纖維毛彈簧圈的註冊批准。本產品用於外周 血管的動脈瘤、動靜脈畸形和動靜脈瘺的填塞。本產品採用可控解脫機制，確保 彈簧圈釋放過程穩定、精準，提升了操作的可控性和安全性。此外，產品具有2D 和3D兩種結構可選擇，能夠廣泛適配臨床需求。本公司將適時在中國開展營銷活 動。 本公司最終未必能夠成功營銷外周可控機械解脫帶纖維毛彈簧圈。本公司股東及 潛在投資者在買賣本公司股份時務請審慎行事。 承董事會命 先瑞達醫療科技控股有限公司 董事會主席、執行董事及首席執行官 李靜 先瑞達醫療科技控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：6669） 自願性公告 外周可控機械解脫帶纖維毛彈簧圈的註冊申請 獲中國國家藥品監督管理局批准 ...

Core Insights - The article highlights the significant transformation occurring in China's biotechnology sector, driven by international investor interest and the competitive advantages of Chinese biotech companies [2][5]. Group 1: Investment Trends - Morgan Stanley has sponsored notable IPOs in the Hong Kong market, including projects from companies like Heng Rui Medicine and Ying En Biology, and has facilitated multiple refinancing projects totaling billions [1][3]. - The Hong Kong Stock Exchange has emerged as the world's second-largest biotechnology financing center, with 12 healthcare companies raising a total of $2.5 billion in the first half of 2025 [3]. - New listings have shown strong market performance, with an average first-day increase of 23.1% for the 12 healthcare companies [3]. Group 2: Financing Activities - Morgan Stanley has assisted Chinese issuers in raising over $5 billion in financing by the end of July, with notable projects including WuXi AppTec's $980 million share placement [4]. - The financing activities reflect a growing demand for biotech stocks, with significant oversubscription and reduced discount rates for recent offerings [4]. Group 3: Global Expansion of Chinese Biotech - Chinese biotech companies are increasingly pursuing international clinical registrations and market entries, with a notable rise in "License-out" agreements [5][6]. - The gap in innovation capabilities between Chinese and U.S. biotech firms has narrowed, with Chinese companies demonstrating significant advancements in drug development efficiency and cost [5][6]. - The total value of transactions related to antibody-drug conjugates (ADCs) has reached approximately $44 billion, indicating robust international collaboration [6]. Group 4: Strategic Collaborations - Chinese biotech firms are forming strategic partnerships with international giants, exemplified by Heng Rui Medicine's $12.5 billion deal with GlaxoSmithKline [6][7]. - The collaboration models are evolving from simple licensing to joint development and new company formations, showcasing increased confidence in Chinese biotech capabilities [6][7]. Group 5: Future Outlook and Challenges - The article emphasizes the need for Chinese biotech companies to overcome regulatory complexities and market entry barriers to enhance their global presence [8][9]. - Recommendations include building international talent teams, improving communication with regulatory bodies, and optimizing government support for innovation [9].

Group 1 - The core point of the article is that Xianruida Medical-B (06669) has received registration approval for its micro-guide wire from the Beijing Drug Administration, leading to a significant increase in its stock price [1] - As of the report, Xianruida Medical's stock rose over 12%, with a current price of 12.11 HKD and a trading volume of 18.9 million HKD [1] - The company plans to conduct marketing activities in China following the approval of the micro-guide wire, which is intended for routine peripheral vascular use [1] Group 2 - In December 2022, Xianruida Medical announced that Boston Scientific made a takeover offer to acquire up to 65% of the company's shares at a price of 20 HKD per share, with an estimated transaction value of approximately 523 million USD [1] - In July 2023, both companies signed a cooperation framework agreement and a service framework agreement to collaborate in areas such as global commercialization, manufacturing services, and product development [1]

Core Viewpoint - Xianruida Medical-B (06669) has seen a significant stock price increase following the announcement of receiving registration approval for its micro-guide wire from the Beijing Drug Administration, which is intended for use in peripheral vascular applications [1] Group 1: Stock Performance - The stock price of Xianruida Medical-B rose over 12% in the afternoon session, with a current increase of 7.84%, trading at HKD 12.11, and a transaction volume of HKD 18.90 million [1] Group 2: Regulatory Approval - The company announced that it received registration approval for its micro-guide wire, which is designed for guiding and placing diagnostic or therapeutic devices in peripheral vascular applications [1] Group 3: Future Plans - Xianruida Medical plans to conduct marketing activities in China in a timely manner following the approval [1] - The company is set to hold a board meeting on August 26 to approve its interim results [1] Group 4: Acquisition and Collaboration - In December 2022, Boston Scientific initiated a takeover bid for Xianruida Medical, offering HKD 20 per share for up to 65% of the company's majority stake, with an estimated transaction value of approximately USD 523 million [1] - In July 2023, both parties signed a cooperation framework agreement and service framework agreement to collaborate in areas such as global commercialization, manufacturing services, and product development [1]

智通财经APP获悉，先瑞达医疗-B(06669)午后涨超12%，截至发稿，涨7.84%，报12.11港元，成交额 1890.18万港元。 消息面上，先瑞达医疗近日公告，集团收到北京市药品监督管理局对微导丝的注册批准。微导丝适用于 常规外周血管內使用，用于引导和放置诊断或治疗用器械。公司将适时在中国开展营销活动。此外，先 瑞达医疗拟于8月26日举行董事会会议批准中期业绩。 值得注意的是，2022年12月，先瑞达医疗发布公告称，波士顿科学向公司先瑞达发起要约收购，以每股 20港元的价格交易先瑞达不超过65%股份的多数股权，预计交易金额约为5.23亿美元，完成交易后，波 科成为先瑞达医疗的控股公司。2023年7月，双方签订了合作框架协议和服务框架协议，双方将在产品 全球商业化、产品制造服务和产品研发等领域开展合作。 ...

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received registration approval from the Beijing Drug Administration for its micro-guide wire, which is intended for use in peripheral vascular procedures [1] Group 1 - The micro-guide wire is designed for guiding and placing diagnostic or therapeutic devices in routine peripheral vascular applications [1] - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received registration approval from the Beijing Drug Administration for its micro-guide wire, which is designed for routine peripheral vascular use to guide and place diagnostic or therapeutic devices [1] Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014 inches and 0.018 inches [1] - The product features a 10 cm soft segment at the tip with a tapered core wire design and a laser-etched wave tube, ensuring excellent delivery and torque control performance [1] - This design aims to assist physicians in addressing complex vascular challenges [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

Core Viewpoint - The company received registration approval for its micro-guide wire from the Beijing Drug Administration, which is designed for routine peripheral vascular use, aiding in the guidance and placement of diagnostic or therapeutic devices [1] Group 1: Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014" and 0.018" [1] - The product features a soft segment at the tip measuring 10 centimeters, designed with a tapered core wire structure [1] - The outer sheath is made of laser-engraved wave tube, ensuring excellent delivery and torque control performance [1] Group 2: Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]

Core Viewpoint - The company, Xianruida Medical-B (06669), has received registration approval from the Beijing Drug Administration for its micro-guide wire, which is designed for routine peripheral vascular use to guide and place diagnostic or therapeutic devices [1] Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014 inches and 0.018 inches [1] - The product features a 10 cm soft segment at the tip with a tapered core wire design and a laser-etched wave tube, ensuring excellent delivery and torque control performance [1] Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]