Core Viewpoint - Angelalign (06699) has seen a stock price increase of over 5%, currently trading at 68.7 HKD, with a transaction volume of 23.6952 million HKD, following the announcement of receiving the MDR-CE certification from TÜV Süd [1] Group 1: Certification and Market Impact - Angelalign recently held a certification ceremony in Shanghai, where TÜV Süd officially awarded the MDR-CE certificate, indicating compliance with EU medical device regulations [1] - The MDR-CE certification signifies that Angelalign's products meet the EU's stringent legal requirements for safety, effectiveness, and lifecycle compliance, enhancing international recognition and market credibility [1] - CEO Hu Jiezhang stated that after over two years of international development, Angelalign's overseas business has grown rapidly, with international cases accounting for over 50% of total cases in the first half of this year, covering over 60 countries and regions [1] Group 2: Strategic Importance - The receipt of the CE certification marks a significant milestone in Angelalign's globalization process, further solidifying the company's competitive foundation in the international invisible orthodontics market [1]

获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期合规性的强 制性法律要求，具有极高的国际认可度与市场公信力。时代天使CEO胡杰章在授证仪式上表示，经过两 年多的国际化发展，时代天使海外业务增长迅速，今年上半年的国际病例数占总案例数比例已超过 50%，业务覆盖60多个国家和地区。此次获得CE认证，是时代天使全球化进程中的重要里程碑，也将 进一步夯实公司在国际隐形矫治市场中的竞争基础。 消息面上，据时代天使官网消息，近日，时代天使在上海举办MDR-CE证书授证仪式。T V南德意志集 团(以下简称"T V南德")在授权仪式上为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机 构(Notified Body)的认可，标志着时代天使隐形矫治相关产品在安全性、有效性及合规性方面全面符合 欧盟医疗器械法规要求，也意味着时代天使在高标准海外市场准入上迈出重要一步。 时代天使(06699)涨超5%，截至发稿，涨4.57%，报68.7港元，成交额2369.52万港元。 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 時代天使科技有限公司 呈交日期: 2026年1月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06699 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： ...

Investment Rating - The report suggests a positive investment outlook for the medical device sector, particularly in brain-computer interface devices, which are expected to see accelerated commercialization due to supportive policies [1][3]. Core Insights - Recent policies have significantly increased support for innovation in medical devices, with the National Medical Products Administration actively promoting faster market entry for brain-computer interface devices, indicating a diverse application landscape and substantial future potential [1][3]. - The pharmaceutical sector is witnessing positive developments, such as GSK's approval of mepolizumab for a new indication in COPD patients, marking it as the first monthly administered biologic in China, which is expected to reduce the annual incidence of severe exacerbations significantly [1][32]. - The report highlights the approval of Wegovy® tablets in the U.S. for weight management, emphasizing its potential impact on the market as the first oral GLP-1 receptor agonist for this purpose [37][40]. Summary by Sections Pharmaceutical Sector - Mepolizumab has been approved for COPD treatment in China, with a monthly dosing schedule, targeting a significant patient population [1][32]. - The A/H share innovation drug sector maintains high activity levels, with new drug approvals and cross-border transactions remaining robust [16][28]. Biologics - Wegovy® tablets have been approved in the U.S. for weight management, showing similar weight loss efficacy to its injectable counterpart, with a significant portion of participants achieving substantial weight loss [37][40]. CXO and Pharmaceutical Supply Chain - The CXO sector continues to show upward momentum, supported by a stable order backlog, with November financing levels slightly above the annual average [44][46]. Medical Devices - The centralized procurement process for high-value medical consumables is progressing steadily, with high selection rates in multiple rounds of bidding, indicating a favorable environment for leading domestic companies [2][52]. Retail Pharmacy - The industry is undergoing a consolidation phase, with leading companies expected to benefit from increased market share through mergers and acquisitions [2][3]. Medical Services and Consumer Healthcare - Aier Eye Hospital's acquisition of 39 institutions for 960 million yuan strengthens its market position, with the acquired entities showing signs of financial recovery [2][3].

12月26日，时代天使(06699.HK)官微发布消息称，近日，时代天使在上海举办MDR-CE证书授证仪式。 T V南德意志集团(T V南德)代表团为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机构 (Notified Body)的认可，标志着时代天使隐形矫治相关产品在安全性、有效性及合规性方面全面符合欧 盟医疗器械法规要求，也意味着时代天使在高标准海外市场准入上迈出重要一步。 他表示，自启动全球化战略以来，时代天使选择优先进入欧美等发达市场，这意味着企业必须在法规理 解、数据安全、产品质量、认证流程等方面全面对标西方最高标准，并以当地医生的使用习惯和认知逻 辑来提供产品与服务。为此，时代天使在国际市场坚持高度本地化策略，围绕牙医这一高专业度人群， 持续优化产品与服务体系。 经过两年多的国际化发展，时代天使海外业务增长迅速，今年上半年的国际病例数占总案例数比例已超 过50%，业务覆盖60多个国家和地区。此次获得CE认证，是时代天使全球化进程中的重要里程碑，也 将进一步夯实公司在国际隐形矫治市场中的竞争基础。 据介绍，T V南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次 ...

Core Insights - Angelalign Biotechnology Co., Ltd. has received the MDR-CE certification, marking a significant step in meeting EU medical device regulations and enhancing its market credibility [1][2] Group 1: Certification and Compliance - The MDR-CE certificate was awarded by T V Süddeutsche Group, a globally recognized Notified Body in medical device certification, indicating that Angelalign's products meet stringent EU safety, efficacy, and compliance standards [1] - The certification process involved rigorous multi-dimensional reviews of product technology, clinical evaluation, quality management systems, and post-market surveillance, reflecting the high standards of the EU's Medical Device Regulation (MDR) [1] Group 2: Strategic Positioning - The CEO of Angelalign emphasized that the CE certification is a result of the company's long-term investment in product development, quality systems, and compliance capabilities, alongside the strict requirements set by T V Süddeutsche [2] - Since initiating its globalization strategy, Angelalign has prioritized entry into developed markets such as Europe and the U.S., necessitating alignment with the highest regulatory standards and local medical practices [2]

Group 1 - The core viewpoint of the news is that Times Angel Biotechnology Co., Ltd. has received the MDR-CE certification from TÜV Rheinland, marking a significant step in meeting EU medical device regulations and enhancing its market credibility in high-standard overseas markets [1][2] - The MDR-CE certification indicates that Times Angel's products comply with the EU's stringent safety, effectiveness, and compliance requirements for medical devices, which involves a rigorous multi-dimensional review process by a recognized Notified Body [1] - TÜV Rheinland is recognized globally for its authority in medical device certification, and the MDR-CE certification is considered one of the most stringent regulatory frameworks worldwide [1] Group 2 - The CEO of Times Angel stated that the CE certification is a result of the company's long-term investment in product development, quality systems, and compliance capabilities, as well as the strict requirements set by TÜV Rheinland [2] - Since initiating its globalization strategy, Times Angel has prioritized entry into developed markets such as Europe and the United States, necessitating alignment with the highest standards in regulations, data security, product quality, and certification processes [2]

本报讯 （记者李春莲）近日，时代天使生物科技有限公司（以下简称"时代天使"）在上海举办MDR- CE证书授证仪式。TV南德意志集团（以下简称"TV南德"）代表团专程莅临现场，为时代天使正式颁发 CE实体证书。此次获得国际权威欧盟公告机构（Notified Body）的认可，标志着时代天使隐形矫治相 关产品在安全性、有效性及合规性方面全面符合欧盟医疗器械法规要求，也意味着时代天使在高标准海 外市场准入上迈出重要一步。 TV南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次时代天使 所获的MDR-CE证书，是依据欧盟《医疗器械法规》（Medical Device Regulation，MDR）颁发的准入 凭证，MDR也是全球最严格的医疗器械监管体系之一，获得这项证书需经过公告机构对产品技术、临 床评价、质量管理体系及上市后监督等多个维度的系统性、多轮次严格审核，流程严谨、复杂，标准极 高。因此，获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期 合规性的强制性法律要求，具有极高的国际认可度与市场公信力。 （文章来源：证券日报） 时代天使CEO胡杰章表示 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 時代天使科技有限公司 呈交日期: 2025年12月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06699 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額 ...

Core Viewpoint - Angelalign Technology (06699) announced a strategic adjustment to its long-term talent strategy, aligning incentives with sustainable value creation, which includes the cancellation of 1.4714 million unvested old stock options and the reissuance of 1.122 million new stock options under the post-IPO stock option plan, pending acceptance by the relevant grantees [1] Group 1 - The company aims to align the interests of its key contributors with those of shareholders through this adjustment [1] - The new structure is designed to be more efficient and results in a lower total number of unexercised stock options [1] - The decision reflects the company's commitment to a performance-oriented culture [1]