此乃要件 請即處理 閣下如對本通函之任何內容或應採取之行動有任何疑問，應諮詢股票經紀或其他註冊證券交易商、銀行經 理、律師、專業會計師或其他專業顧問。 閣下如已售出或轉讓名下所有堃博醫療控股有限公司之股份，應立即將本通函連同隨附之代表委任表格送 交買主、承讓人或經手買賣或轉讓之銀行、股票經紀或其他代理商，以便轉交買主或承讓人。 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通函之內容概不負責，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通函全部或任何部分內容而產生或因依賴該等內容而引致的任何 損失承擔任何責任。 Broncus Holding Corporation 堃 博 醫 療 控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2216） (1)提呈截至2024年12月31日止年度本公司及 其附屬公司的經審核綜合財務報表、 董事會報告及核數師報告； (2)重選退任董事； (3)續聘核數師； (4)發行股份及購回股份之一般授權； 及 (5)股東週年大會通告 堃博醫療控股有限公司謹訂於2025年5月16日（星期五）上午十時正假座中國杭州市濱江區西興街道江陵 路88號8幢8層801 ...

Group 1 - The National Medical Products Administration (NMPA) is seeking public opinion on measures to optimize the lifecycle regulation to support the innovation of high-end medical devices [1] - The NMPA plans to strengthen standardization to lead innovation, including the rapid release of standards for medical exoskeleton robots and radioactive nuclide imaging devices [1] - A total of 308 medical device products were approved for registration by the NMPA in March 2025, including 248 domestic Class III medical devices and 34 imported Class III medical devices [1] Group 2 - Huatai Securities believes that the policy for medical equipment updates will gradually stimulate demand in the medical device sector, benefiting leading companies [1] - The equipment update policy is expected to last for three years and may expand to other areas such as endoscopy, leading to a recovery in hospital procurement [1] - The medical device market is anticipated to see a sustained recovery as previously suppressed demand is gradually released [1] Group 3 - Related companies in the medical device industry chain listed in Hong Kong include Qiming Medical-B (02500), Aikang Medical (01789), MicroPort Scientific Corporation-B (02252), Peijia Medical-B (09996), MicroPort Medical (00853), Kunbo Medical-B (02216), and Yimai Sunshine (02522) [2]

肺癌是全球面临的重大公共卫生问题之一，国家癌症中心公布的2022年数据显示，我国肺癌新发病例数 为106.06万例，是我国恶性肿瘤的"第一杀手"。尽管现有治疗手段多样，但这些治疗手段却面临适用人 群相对狭窄，且并发症多、治疗效果不佳等问题，BroncAblate智衡上市为患者提供超微创介入治疗解 决方案，打破了传统治疗的困境僵局。 堃博医疗-B(02216)发布公告，公司核心产品，自主研发的全球首款经自然腔道射频消融肺癌治疗器械 ——BroncAblate智衡一次性使用肺部射频消融导管(下称BroncAblate智衡)正式获得中国国家药品监督管 理局(NMPA)批准在中国上市，引领肺癌治疗进入超微创介入治疗时代。 BroncAblate智衡为全球首款通过临床研究验证的经自然腔道肺癌射频消融介入治疗器械，由公司自主 研发，通过关键技术创新，解决了此前肺部射频消融过程中，由于肺部含气量大、阻抗过高难以持续稳 定能量输出、消融范围受局限的技术难题，实现经自然腔道(支气管)将射频介入治疗导管精准送达肺部 病灶中心，通过射频消融灭活肿瘤组织，带来微创、可重复的肺部肿瘤精准靶向超微创介入疗法，成功 填补该领域的全球空白。 ...

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倚 賴該等內容而引致的任何損失承擔任何責任。 Broncus Holding Corporation 堃 博醫療控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2216） 內幕消息 核心產品BroncAblate®智衡®一次性使用肺部射頻消融導管在中國獲批上市 本公告由堃博醫療控股集團（「本公司」）根據香港聯合交易所有限公司證券上市規 則（「上市規則」）第13.09條及香港法例第571章證券及期貨條例第XIVA部內幕消 息條文（定義見上市規則）刊發。 本公司的董事會（「董事會」）欣然宣佈，本公司核心產品，自主研發的全球首款經 自然腔道射頻消融肺癌治療器械——BroncAblate®智衡®一次性使用肺部射頻消融 導管（下稱BroncAblate®智衡®）正式獲得中國國家藥品監督管理局(NMPA)批准在 中國上市，引領肺癌治療進入超微創介入治療時代。 1 肺癌是全球面臨的重大公共衛生問題之一，國家癌症中心公佈的2022年數據顯 示，我國肺癌 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 第 1 頁 共 6 頁 v 1.3.0 FF305 確認 不適用 第一章節註釋： 若股份曾以超過一個每股價格發行/出售/購回/贖回，則須提供每股成交量加權平均價格。 若購回/贖回股份將於期終結存日期之後購回/贖回結算完成之時予以註銷，則該等購回/贖回股份仍屬A部所述期終結存當日的已發行股份的一部分。該等購回/贖回股份的詳情應在B部作 出披露。 表格類別： 股票 狀態： 新提交 公司名稱： 堃博医疗控股有限公司 呈交日期： 2025年4月9日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 不適用 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 堃博医疗控股有限公司 呈交日期： 2025年4月7日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 02216 | 說明 | 每股面值0.000025美元之普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不 ...

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 2025年4月8日至11日， 第91届中国国际医疗器械（春季）博览会（CMEF） 将在上海国家会展中心拉开帷幕。作为亚太地区规模最大的医疗科技展会，CMEF始终 是行业风向标，不仅汇聚全球创新技术，更见证着产业发展的新趋势。本届展会预计吸引 全球30多个国家和地区的近 5000家 企业，携 数万款 前沿产品集中亮相 ，以"创新科技，智领未来"为主题，共同探讨医疗科技的突破与未来。 CMEF不仅是一场产品与技术的集中展示，更是医疗行业生态的一次深度联动。从人工智能驱动的医学影像，到手术机器人赋能精准医疗，从智慧医院建设，到国 产医疗设备的崛起，CMEF2025通过高规格论坛、产业对话和技术展示，构建起全方位的交流平台，为行业发展提供新的思路与动能。 在这一医疗科技的年度盛会上，哪些企业将携最新技术亮相？哪些创新产品值得重点关注？ 思宇梳理了本届CMEF的亮点企业，一起来看它们如何在这场科技盛宴 中抢占先机！ P.S. 展位图附于文末，感兴趣的读者可按图索骥 ...

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 近日， 堃博 医疗 发布了2024年度业绩公告。 # 业绩解读 根据堃博医疗2024年度业绩公告，公司在报告期内实现产品销售收入约 5800万人民币 ， 全年净亏损同比缩窄 46%。这一业绩表现主要得益于公司在产品临床进展、市场推广及全球化布局等方面的持续努力。 在临床数据积累方面，公司核心产品取得显著进展： 在市场推广方面，公司产品已在中国多家医院实现临床应用： 在全球化布局方面， 公司海外业务稳步扩展： 截至2024年12月31日，产品已覆盖37个国家和地区，包括美国、英国、德国、法国等发达国家。 TLD靶向去神经消融系统： 慢阻肺急性加重介入治疗产品的上市前临床试验入组顺利，截至2024年12月 31日，已有超过半数受试者完成入组。 LungPro增强现实光学全肺诊疗导航： 4月，中华医学会呼吸病学分会介入学组发布《增强现实光学全 肺诊疗导航引导下肺外周结节诊断、定位及治疗专家共识》，为产品临床应用提供了权威指导。 智衡 ® BroncAblate ...

Broncus Holding Corporation 堃博醫療控股有限公司 （「公司」） (於開曼群島註冊成立的有限公司) 提名委員會職權範圍 定義 1. 就本職權範圍（「職權範圍」）而言： 董事會指公司之董事會。 公司秘書指公司任命之任何一名聯席公司秘書。 董事指董事會成員。 本集團指於有關期間，公司及其附屬公司、併表聯屬實體和聯營公司；或若 文義另有所指，於公司成為其現時附屬公司和聯營公司之控股公司前之期 間，公司之現時附屬公司和聯營公司；或其現時附屬公司和聯營公司或其前 身（視乎具體情況）所營運之業務。 《上市規則》指《香港聯合交易所有限公司證券上市規則》（經不時修訂）。 提名委員會指董事會根據本職權範圍第2條通過之決議而設立之提名委員會。 聯交所指香港聯合交易所有限公司。 成立 高級管理層指董事長、首席執行官、總裁、首席財務官、首席科技官、及董 事會不時委任的公司任何其他高級人員；公司之任何其他高級人員，而其薪 酬待遇或建議薪酬待遇比任何由董事會委任的高級人員較為優厚；及任何其 他由公司的薪酬委員會釐定為高級管理層的公司僱員。 股東指公司之股東。 會議之次數及程序 股東周年大會 2 3. 董事會將在 ...

Financial Performance - Revenue for the year ended December 31, 2024, was $8,131,000, a decrease of 21% compared to $10,255,000 in 2023[4] - Gross profit for the same period was $6,139,000, down 15% from $7,227,000 in the previous year[4] - The net loss for the year was $15,303,000, representing a 46% improvement from a loss of $28,092,000 in 2023[4] - Total comprehensive loss for the year was $16,129,000, compared to $28,695,000 in 2023, reflecting a substantial improvement[9] - The company reported a significant reduction in adjusted net loss, from $27,536,000 in 2023 to $15,067,000 in 2024, a decrease of 45%[4] - The company reported a pre-tax loss of $15,303,000 for 2024, compared to a loss of $28,091,000 in 2023, indicating an improvement of 45.5%[40] - The company’s total revenue for the reporting period was $8.1 million, with annual losses narrowing from $28.1 million in fiscal 2023 to $15.3 million, a year-on-year reduction of 46%[56] - Total customer contract revenue for 2024 was $8,131,000, a decrease of 20.7% from $10,255,000 in 2023[22] Cash and Assets - Cash and bank balances decreased by 11% to $139,346,000 from $156,647,000 year-over-year[4] - Cash and cash equivalents fell significantly from $83,564,000 in 2023 to $46,473,000 in 2024, a decline of about 44.5%[10] - Total assets less current liabilities decreased from $186,647,000 in 2023 to $169,477,000 in 2024, a decline of approximately 9.2%[11] - Non-current assets totalled $24,105,000 in 2024, slightly up from $23,153,000 in 2023, indicating a growth of about 4.1%[10] - The capital debt ratio as of December 31, 2024, was 0.2%, significantly lower than 1.3% in 2023[111] Sales and Revenue Breakdown - Revenue from the sale of medical devices and consumables dropped from $11,984,000 in 2023 to $7,571,000 in 2024, a decrease of approximately 36.5%[21] - Revenue from major customers included $1,547,000 from Customer B and $1,432,000 from Customer C in 2024, while Customer A contributed $6,317,000 in 2023[20] - Revenue from mainland China decreased to $3,214,000 in 2024 from $6,465,000 in 2023, representing a decline of 50.3%[22] - Revenue from the European Union increased to $2,628,000 in 2024 from $1,848,000 in 2023, showing a growth of 42.2%[22] - Other countries/regions generated $2,289,000 in revenue for 2024, up from $1,942,000 in 2023, an increase of 17.8%[22] Product Development and Innovation - The company launched the BroncQCT® software, which enhances the efficiency of CT image reading for lung diagnostics, receiving approval for market entry in March 2025[6] - Clinical trials for the BroncAblate® system demonstrated its safety and effectiveness in treating lung tumors, with results published in a leading journal[5] - The company is focused on developing and upgrading interventional treatment products for lung diseases, particularly lung cancer and severe COPD, to enhance patient quality of life and potentially extend survival[50] - The company launched several innovative products and clinical procedures in the respiratory intervention field, with successful clinical applications in multiple hospitals across various provinces[53] - The company’s innovative product, the BroncAblate® system, demonstrated safety and efficacy in treating lung tumors, as published in the journal Respirology[52] Market Expansion and Regulatory Approvals - The company achieved a 29% year-over-year increase in overseas sales revenue, expanding its presence to 37 countries/regions by the end of 2024[7] - The company has obtained 66 registration certificates overseas, including two new FDA registrations for Biostar® and BroncTru®[7] - The company’s overseas market expansion included new registrations in Poland and Saudi Arabia in 2024[54] - The company has obtained 83 registration certificates for its products both domestically and internationally, with several products currently in the global registration process[92] Cost Management and Expenses - The cost of sales for the same period was $2.0 million, down 34.2% from $3.0 million in the previous year, indicating effective cost management[102] - Sales and distribution expenses were $8.5 million, a decrease of approximately $3.0 million or 26.1% year-on-year, reflecting effective optimization of sales expenditure[105] - Total administrative expenses decreased by 18.6% to approximately $7.3 million in 2024 from $8.9 million in 2023[108] - R&D expenses for the year ended December 31, 2024, were approximately $11.5 million, a decrease of 43.1% compared to $20.2 million in 2023[106] Employee and Management Information - The company had 200 employees as of December 31, 2024, with 178 based in China and 22 overseas[130] - Total employee costs for the reporting period were approximately $14.6 million, down from $22.6 million in the same period of 2023[130] - The company reported a significant narrowing of losses compared to the same period last year, with total management compensation decreasing from $726,000 in 2023 to $354,000 in 2024[47] Corporate Governance and Compliance - The audit committee reviewed the annual consolidated financial statements for the year ending December 31, 2024, and found them compliant with applicable accounting standards[132] - The company has complied with all applicable corporate governance codes during the reporting period, except for the separation of the roles of Chairman and CEO[123] - The company is listed on the Hong Kong Stock Exchange, indicating its compliance with local regulations[146] Future Outlook and Strategic Plans - The company plans to selectively expand its global business, leveraging its competitive products to provide quality medical services worldwide[99] - The company aims to strengthen the penetration and influence of its treatment products in the Chinese market while focusing on the pre-market clinical trials of its in-development products[98] - The company is reallocating funds to enhance operational efficiency and capitalize on new market opportunities, particularly in the development of core products[140] - The company aims to strengthen its competitive position in the respiratory disease treatment sector through innovation and strategic resource allocation[142]