"港澳药械通"是《粤港澳大湾区药品医疗器械监管创新发展工作方案》的核心落地举措，进入名单的粤 港澳大湾区的指定医疗机构，可经审批进口使用粤港澳大湾区专项医药政策，允许指定医疗机构经审批 使用港澳已上市的临床急需药品及具有先进性的医疗器械。 美中嘉和(02453)发布公告，公司子公司广州泰和肿瘤医院于2025年12月8日，获广东省卫生健康委员会 与广东省药品监督管理局批准进入粤港澳大湾区"港澳药械通"指定医疗机构名单。 此举还将推动公司与港澳医药资源的深度对接，提升临床诊疗水平和科研能力。通过引入国际前沿药 械，优化肿瘤治疗方案，加快与国际医疗标准接轨，助力构建高水平的肿瘤疾病诊疗体系，持续提升患 者服务体验与治疗效果。 本次资格认定使公司成为具备港澳创新药械使用资质的专业肿瘤医疗机构。公司可率先引进与使用已在 中国港澳上市、境内尚未获批的肿瘤领域急需药械，包括新型原研药等，进一步拓宽业务边界，与市场 形成差异化竞争优势，为更多的肿瘤患者提供急需药品，同时强化公司在肿瘤医疗领域的竞争优势。 ...

Core Viewpoint - The company, Meizhong Jiahe (02453), announced that its subsidiary, Guangzhou Taihe Oncology Hospital, has been approved to enter the "Hong Kong-Macao Drug and Medical Device Access" designated medical institution list, enhancing its capabilities in oncology treatment and competitive advantage in the market [1] Group 1 - The approval was granted by the Guangdong Provincial Health Commission and the Guangdong Provincial Drug Administration, allowing the hospital to import and use urgently needed drugs and advanced medical devices that are already listed in Hong Kong and Macao but not yet approved in mainland China [1] - This qualification enables the company to be recognized as a professional oncology medical institution with the capability to utilize innovative drugs and medical devices from Hong Kong and Macao, thereby broadening its business scope [1] - The initiative will facilitate deeper integration with Hong Kong and Macao medical resources, enhancing clinical diagnosis and treatment levels, and accelerating alignment with international medical standards [1] Group 2 - The introduction of cutting-edge drugs and medical devices is expected to optimize oncology treatment plans and improve patient service experience and treatment outcomes [1] - The company aims to provide urgently needed medications for more oncology patients, reinforcing its competitive edge in the oncology medical field [1]

格隆汇12月8日丨美中嘉和(02453.HK)宣布，公司子公司广州泰和肿瘤医院于2025年12月8日，获广东省 卫生健康委员会与广东省药品监督管理局批准进入粤港澳大湾区「港澳药械通」指定医疗机构名单。 本次资格认定使公司成为具备港澳创新药械使用资质的专业肿瘤医疗机构。公司可率先引进与使用已在 港澳上市、境内尚未获批的肿瘤领域急需药械，包括新型原研药等，进一步拓宽业务边界，与市场形成 差异化竞争优势，为更多的肿瘤患者提供急需药品，同时强化公司在肿瘤医疗领域的竞争优势。 「港澳药械通」是《粤港澳大湾区药品医疗器械监管创新发展工作方案》的核心落地举措，进入名单的 粤港澳大湾区的指定医疗机构，可经审批进口使用粤港澳大湾区专项医药政策，允许指定医疗机构经审 批使用港澳已上市的临床急需药品及具有先进性的医疗器械。 此举还将推动公司与港澳医药资源的深度对接，提升临床诊疗水平和科研能力。通过引入国际前沿药 械，优化肿瘤治疗方案，加快与国际医疗标准接轨，助力构建高水平的肿瘤疾病诊疗体系，持续提升患 者服务体验与治疗效果。 ...

本公告乃由美中嘉和醫學技術發展集團股份有限公司（「本公司」）董事會（「董事 會」）自願刊發。 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，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致之任何損失承擔任何責任。 CONCORD HEALTHCARE GROUP CO., LTD. 美中嘉和醫學技術發展集團股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2453） 自願公告 公司獲批進入「港澳藥械通」指定醫療機構名單 承董事會命 美中嘉和醫學技術發展集團股份有限公司 董事長兼執行董事 楊建宇 董事會欣然宣佈，本公司子公司廣州泰和腫瘤醫院於2025年12月8日，獲廣東省 衛生健康委員會與廣東省藥品監督管理局批准進入粵港澳大灣區「港澳藥械通」指 定醫療機構名單。 「港澳藥械通」是《粵港澳大灣區藥品醫療器械監管創新發展工作方案》的核心落地 舉措，進入名單的粵港澳大灣區的指定醫療機構，可經審批進口使用粵港澳大灣 區專項醫藥政策，允許指定醫療機構經審批使用港澳已上市的臨床急需藥品及具 有先進性的醫療器械。 本 ...

| IQ | 南方医科大学第八附属医院 | 三级 | 佛山市顺德区伦敦街道办事处态 | | --- | --- | --- | --- | | | (佛山市顺德区第一人民医院) | | 村村委会甲子路1号 | | | 佛山市南海区人民医院 | | 佛山市南海区狮山镇桂丹路 120 | | 17 | (华南理工大学附属第六医院) | 三级 | ਵੇ | | 18 | 厂东省人民医院南海医院 | 三级 | 佛山市南海区桂城街道 夏东路 23 | | | | | ਵੇ | | 19 | 和祐至臻医院 | 二级 | 佛山市顺德区北溶镇君兰社区和 仁路1号1号楼负1层C区 | | | | | 105-150 号房、5 号楼 | | 20 | 惠州市第一人民医院 | 三级 | 惠州市惠城区北江三新南路 20号 | | | | | 惠州市惠城区鹅岭北路 41 号;惠 | | 21 | 惠州市中心人民医院 | 三级 | 州市惠城区下埔横江四路8号; | | | | | 惠州市仲恺高新区陈江街道胜利 | | | | | 村甲子LED工业园新陈大道北面 | | 22 | 惠阳三和医院 | 三级 | 惠州市惠阳区淡水金惠大道康和 ...

Policy Developments - Guizhou Province is advancing the monitoring of adverse reactions to medical institution formulations, highlighting issues such as insufficient awareness and inadequate responsibility among institutions [1] - Liaoning Province is implementing a tiered management system for outpatient medical insurance settlements at designated medical institutions starting next year, aiming to improve the efficiency of medical insurance fund usage [2] Drug and Device Approvals - GlaxoSmithKline announced that the NMPA has approved the use of its Shingrix vaccine for adults aged 18 and older with known diseases or treatments that increase the risk of shingles, addressing a significant health concern in China with approximately 6 million cases annually [2] - Shanghai Pharmaceuticals received FDA approval for its doxycycline capsules, primarily used for treating inflammatory lesions of rosacea, with projected sales of approximately $130 million in the U.S. for 2024 [3] - Gilead Sciences has completed pre-NDA communication with the NMPA regarding its new drug denifanstat for treating moderate to severe acne, planning to submit the application soon [4] - BD Medical's PleurX IPC system has been approved for clinical use in mainland China under the "Hong Kong and Macau Drug and Device Pass" policy [5] Capital Market Activities - Shanghai Guotou signed agreements with 10 general partners during the 2025 Shanghai International Biopharmaceutical Week, marking a significant step in building a comprehensive fund matrix for the biopharmaceutical industry [6][7] - Jinhai Biological announced plans to issue shares through a simplified procedure, which was approved by its board and supervisory board [8] Industry Events - Guangdong Province's Drug Inspection Institute has launched a new experimental zone for batch release, enhancing the province's capacity for vaccine quality assurance [9] Public Sentiment Alerts - Fosun Pharma announced the withdrawal of its registration application for dimethyl succinate for the treatment of non-small cell lung cancer, stating that this will not significantly impact current performance as they plan to improve the registration materials and resubmit [10]

Core Viewpoint - Jenscare Scientific's product LuX-Valve Plus has been approved for commercialization in designated medical institutions in the Greater Bay Area, which is expected to enhance the company's market penetration and revenue growth [1] Group 1: Company Developments - Jenscare Scientific's LuX-Valve Plus has received approval to enter the Hong Kong and Macau Medical Device Directory, allowing its use in mainland China [1] - The approval is part of the "Hong Kong and Macau Medical Device Pass" policy aimed at facilitating the use of urgently needed medical devices in the Greater Bay Area [1] - The company plans to leverage this policy opportunity to accelerate the commercialization of LuX-Valve Plus and address unmet clinical needs [1] Group 2: Market Context - The "Hong Kong and Macau Medical Device Pass" policy is designed to provide a more efficient access channel for innovative medical devices in the Greater Bay Area [1] - This initiative aims to meet patients' urgent demand for advanced medical technologies and offer diverse treatment options [1] - The company anticipates that the experience gained from this initiative will support its future expansion in domestic and international markets [1]

Core Viewpoint - Jenscare Scientific's product LuX-Valve Plus has been approved for commercialization in the Greater Bay Area, enhancing the company's market penetration and growth potential [1] Group 1: Company Developments - Jenscare Scientific (Netherlands) B.V. has received approval for its LuX-Valve Plus product to enter the Hong Kong and Macau medical device directory [1] - The approval allows for commercial clinical use in designated medical institutions within the Greater Bay Area [1] - The company aims to leverage the "Hong Kong and Macau Medical Device Pass" policy to accelerate the market penetration of LuX-Valve Plus [1] Group 2: Industry Context - The "Hong Kong and Macau Medical Device Pass" is a medical innovation policy implemented in the Guangdong-Hong Kong-Macao Greater Bay Area [1] - This policy facilitates the use of urgently needed drugs or medical devices in mainland clinical settings after approval, addressing patient needs for advanced medical technologies [1] - The initiative aims to provide diverse treatment options for patients and create an efficient access channel for innovative medical devices [1]

Core Viewpoint - The approval of LuX-Valve Plus for commercial clinical use in the Greater Bay Area marks a significant advancement in addressing the unmet clinical needs of patients with severe tricuspid regurgitation, particularly in high-risk surgical cases [1][2] Group 1: Product Approval and Market Entry - Jenscare Scientific's LuX-Valve Plus has been officially approved to enter the Hong Kong-Macao Medical Device Directory, allowing its use in designated medical institutions in the Greater Bay Area [1] - The "Hong Kong-Macao Medical Device Pass" policy aims to facilitate the entry of urgently needed medical devices and drugs into the mainland, enhancing patient access to advanced medical technologies [1] Group 2: Product Features and Clinical Performance - LuX-Valve Plus is designed specifically for patients with severe tricuspid regurgitation and complex anatomical structures, offering a solution where few effective treatments exist [2] - The product features innovative design elements such as inter-ventricular anchoring and adaptive anti-leak rings, available in seven sizes from 40mm to 70mm, demonstrating excellent clinical performance and safety [2] Group 3: Strategic Market Expansion - The company plans to leverage the "Hong Kong-Macao Medical Device Pass" policy to accelerate the commercialization of LuX-Valve Plus in the Greater Bay Area, aiming to meet the significant clinical demand [2] - Successful implantation and follow-up results globally have established LuX-Valve Plus's clinical value and advanced technology, which will support the company's long-term revenue growth and market expansion [2]

Core Viewpoint - Jenscare Scientific (Netherlands) B.V., a subsidiary of the company, has received approval for its LuX-Valve Plus product to enter the Hong Kong and Macau Medical Device Directory, allowing for commercial clinical use in designated medical institutions within the Greater Bay Area [1] Group 1 - The "Hong Kong and Macau Medical Device Pass" is a medical innovation policy implemented in the Guangdong-Hong Kong-Macau Greater Bay Area, facilitating the use of urgently needed drugs or medical devices in public hospitals after approval [1] - The policy aims to meet patients' urgent needs for advanced medical technologies and provide a wider range of treatment options [1] - It also offers an efficient access channel for innovative medical devices [1]