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2月11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（不包括庫存股份）數 目 | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | 每股發行/出售價 ...

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2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 ...

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2月5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 ...

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) FF305 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1月23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) | 0 ...

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1月21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（不包括庫存股份）數 目 | 佔有 ...

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) 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（不包括庫存股份）數 目 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) ...

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份內容所產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Broncus Holding Corporation 本公告由堃博醫療控股有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自 願作出。 本公司董事會（「董事會」）謹此宣佈，於2024年12月12日，董事會決議行使根據 本公司股東（「股東」）於2024年5月20日舉行的本公司股東週年大會上通過的決議 案授予董事會的一般授權（「購回授權」）項下的權力，不時於公開市場購回本公司 股份（「股份」）（「建議股份購回」）。建議股份購回將以本公司現有可用現金撥付。 本公司不會在對本公司營運資金狀況造成重大不利影響的情況下進行購回。本公 司其後將在董事會認為適當的情況下註銷、以庫存方式持有、出售或轉讓購回股 份（如有）。 本公司現時的財務狀況穩健。董事會認為股份現時的成交價未能反映其內在價 值。董事會相信，建議股份購回可提升股份的價值，從而提高股東的回報。此 外，董事會相信，建議股份購回反映本公司對自身的長遠業 ...

Financial Performance - Revenue for the first half of 2024 was $3.704 million, a decrease of 29% compared to $5.234 million in the same period of 2023[4] - Gross profit decreased by 27% to $2.954 million, with a gross margin of 80% due to effective cost reduction strategies[5] - Net loss narrowed by 46% year-on-year, from $14.731 million in 2023 to $7.943 million in 2024[5] - Other income and gains increased by 37% to $3.450 million, compared to $2.512 million in the previous year[4] - For the six months ended June 30, 2024, the company's revenue was $3.7 million, a decrease of 29% compared to $5.2 million for the same period in 2023[34] - Gross profit for the six months ended June 30, 2024, was $3.0 million, with a gross margin increase from 77% to 80% compared to the same period in 2023[37] - The company reported a net loss of $7,943,000 for the six months ended June 30, 2024, compared to a net loss of $14,731,000 in 2023, indicating a 46.1% improvement[92] - The total comprehensive loss for the period was $8,290,000, compared to a loss of $16,602,000 in the prior year, reflecting a decrease of about 50%[97] Cost Management - R&D expenses decreased by 37% to $6.491 million, down from $10.232 million in the previous year[4] - Sales and distribution expenses were reduced by 41% to $3.755 million, compared to $6.365 million in 2023[4] - The company has implemented cost optimization measures, reducing production costs while enhancing supply chain management and safety[7] - Research and development costs decreased to $6,491,000 from $10,232,000, reflecting a reduction of 36.0%[92] - Total employee costs for the six months ended June 30, 2024, were $3.51 million, representing 54% of total costs, down from $5.81 million (57%) in the same period last year[41] - Administrative expenses decreased by 22% to approximately $3.6 million for the six months ended June 30, 2024[42] Product Development and Innovation - The InterVapor® system has been commercialized in over 60 hospitals in China, with approximately 180 hospitals having trialed the technology[6] - The BroncTru® device has been recognized by doctors since its launch in September 2023, enhancing procedural efficiency in lung biopsies and other treatments[6] - The TLD system is currently in clinical trials, with over 80 subjects enrolled across multiple medical centers in China for the treatment of acute COPD[7] - The company is focusing R&D efforts on treatment products for major lung diseases such as lung cancer and COPD, aiming to solidify its leading position in the respiratory intervention market[7] - The RF-II radiofrequency ablation system, developed in partnership with Guangzhou Medical University, has completed its clinical trial, confirming its safety and efficacy in treating lung cancer[16] - The company is advancing clinical trials and registration processes for its innovative lung disease intervention products, including the RF-II system for lung cancer[8] - The company has established a comprehensive interventional respiratory platform, addressing significant clinical needs in lung disease diagnosis and treatment[9] Market Expansion - The company has achieved procurement prices for its products in 28 provinces, facilitating broader market access[6] - The company is actively advancing the overseas registration and market access of new products[28] - The company aims to enhance the penetration and influence of its COPD treatment products in the Chinese market and accelerate the clinical development and commercialization of its pipeline products[33] - The company participated in over 40 international and domestic academic conferences in the first half of 2024, covering approximately 20,000 industry experts and achieving over 200,000 views[29] Shareholder Information - As of June 30, 2024, the total number of issued shares is 527,198,076, with key executives holding specific shares: Xu Hong holds 1,505,912 shares (0.29%) and Kuang Yanhong holds 2,999,396 shares (0.57%)[55][56] - Major shareholders include QM12 Limited with 81,412,808 shares (15.44%) and Qiming Venture Partners IV, L.P. with 87,358,248 shares (16.57%) as of June 30, 2024[57][58] - The company has adopted two equity incentive plans: (i) stock option plan and (ii) restricted share unit plan, with no new shares granted during the reporting period[62] - The total number of stock options outstanding as of June 30, 2024, is 6,451,016, with a weighted average exercise price of $0.31, compared to 10,186,864 options at a price of $0.42 as of December 31, 2023[125] Compliance and Governance - The company has complied with the listing rules regarding the number of independent non-executive directors after recent board changes, including the appointment of David Scott Lim as an independent non-executive director[54] - The company maintained compliance with the Corporate Governance Code, with the exception of the separation of the roles of Chairman and CEO[90] - The company is committed to compliance with the Securities and Futures Ordinance as amended on October 25, 2023[142] Financial Position - Cash and bank balances as of June 30, 2024, totaled $146.3 million, indicating sufficient funds to support business operations and development[43] - The capital debt ratio as of June 30, 2024, was 1.06%, down from 1.27% as of December 31, 2023[44] - The company's cash and cash equivalents decreased to $56,617,000 from $83,564,000, a decline of 32.3%[94] - The total equity attributable to the owners of the parent company was $177,191,000, down from $185,370,000[95] Future Outlook - The company plans to selectively expand its global business while continuing to develop various underlying technologies and supporting technologies[33] - The company is exploring potential mergers and acquisitions to drive strategic growth initiatives[142] - The company is investing in new technologies to improve product offerings and operational efficiency[142]

Financial Data and Key Metrics Changes - The overall sales of consumables increased by 29% year-on-year, primarily driven by the growth in InterVapor sales [4] - Gross margin improved from 76% to 80%, attributed to reduced production costs after localizing manufacturing [13] Business Line Data and Key Metrics Changes - The company is currently experiencing a temporary stagnation with the Interweaver Plus product, awaiting breakeven before further development [5] - The TLD product line has successfully treated over 90 patients, indicating strong market acceptance [3] Market Data and Key Metrics Changes - The company has made significant inroads in the Asian market, particularly in Thailand, Indonesia, and the Middle East, contributing to overall sales growth [16] - The market for COPD and asthma treatments is substantial, with new cases and mortality rates indicating a large potential customer base [21] Company Strategy and Development Direction - The company aims to leverage its localized production capabilities to reduce costs and expand its market reach, focusing on both domestic and international markets [11] - There is a strategic shift towards bundling new products with existing navigation products to enhance market penetration [22] Management's Comments on Operating Environment and Future Outlook - Management expressed a cautious outlook on the competitive landscape, emphasizing the need for patient and physician education to drive product adoption [9] - The company is committed to navigating regulatory challenges and is optimistic about future product approvals, which are expected to drive sales growth [17] Other Important Information - The company has identified significant issues in the market, including the need for better patient education and the impact of national healthcare regulations on product adoption [9] - The company is actively working on obtaining necessary certifications for new products to ensure compliance and market readiness [5] Q&A Session Summary Question: What is the feedback from doctors regarding the new RF2 product? - Management indicated that the feedback from clinical trials has been positive, with doctors requiring about 5 to 10 cases to become proficient in using the technology [15] Question: What is the expected market space for lung cancer treatment? - Management expects the market for lung cancer treatment to remain robust, with significant growth potential as new products are introduced [18] Question: Why did revenue decline despite an increase in consumable sales? - The decline in revenue is attributed to a strategic shift in focus from navigation products to treatment consumables, which is expected to stabilize in the future [22]

Financial Performance - Revenue for the first half of 2024 decreased by 29% to $3.704 million compared to $5.234 million in the same period of 2023[3] - Gross profit for the first half of 2024 decreased by 27% to $2.954 million compared to $4.026 million in the same period of 2023[3] - Net loss for the first half of 2024 narrowed by 46% to $7.943 million compared to $14.731 million in the same period of 2023[3] - Revenue for the first half of 2024 decreased to $3.704 million, compared to $5.234 million in the same period of 2023, reflecting a decline of 29.2%[6] - Gross profit for the first half of 2024 was $2.954 million, down from $4.026 million in 2023, a decrease of 26.6%[6] - Net loss for the first half of 2024 was $7.943 million, an improvement from the $14.731 million loss in 2023, reflecting a 46.1% reduction in losses[6] - Total comprehensive loss for the first half of 2024 was $8.290 million, compared to $16.602 million in 2023, showing a 50.1% improvement[7] - Revenue from external customers in Mainland China decreased to $2.359 million in H1 2024 from $4.251 million in H1 2023, a decline of 44.5%[17] - Total revenue from external customers dropped to $3.704 million in H1 2024 from $5.234 million in H1 2023, a decrease of 29.2%[17] - Revenue for the six months ended June 30, 2024, was $3.7 million, a decrease from $5.2 million in the same period last year[52] - Adjusted net loss for the six months ended June 30, 2024 was $7.832 million, compared to $14.291 million in the same period in 2023[67] R&D and Product Development - R&D expenses for the first half of 2024 decreased by 37% to $6.491 million compared to $10.232 million in the same period of 2023[3] - R&D costs for the first half of 2024 were $6.491 million, a reduction of 36.6% compared to $10.232 million in 2023[6] - R&D costs decreased to $6.491 million in H1 2024 from $10.232 million in H1 2023, a reduction of 36.6%[23] - R&D expenses decreased by 37% to $6.5 million, reflecting cost optimization and focus on core product development[59] - The company's lung cancer intervention product, the Zhiheng RF-II radiofrequency ablation system, is the world's first bronchoscopic intervention product with an indication for lung cancer and has submitted for regulatory review in China[5] - The key clinical study for the Targeted Lung Denervation (TLD) system for acute COPD treatment has enrolled over 80 subjects across multiple medical centers in China[5] - The company's TLD radiofrequency ablation system, developed in collaboration with West China Hospital, is in a key clinical trial phase with over 80 subjects enrolled across 20 research centers as of June 30, 2024[34] - The TLD system is expected to complete all subject follow-ups by July 2026, with clinical trial reports and data to be released no earlier than that date[34] - The company's product pipeline includes InterVapor® and TLD, targeting severe and acute COPD, with InterVapor® already holding CE and NMPA certifications[32] - The Zhihang RF-II radiofrequency ablation system, developed in collaboration with Guangzhou Medical University, is the world's first bronchoscopic intervention product for lung cancer treatment[36] - The Zhihang RF-II completed its clinical trial BRONC-RF-II in March 2023, demonstrating safety and efficacy, and has been submitted for regulatory approval[37] - The company has three navigation products: LungPoint, LungPoint Plus/Archimedes Lite, and LungPro/Archimedes system, covering different hospital needs[39] - The LungPro/Archimedes system, approved in the US, EU, and China, represents an upgrade to the LungPoint VBN system, enabling precise navigation for peripheral lesions[40] - The company focuses on developing innovative technologies for lung disease navigation, diagnosis, and treatment, leveraging international technology and local R&D cost advantages[41] Product Commercialization and Market Penetration - The InterVapor® thermal vapor therapy system has been commercially applied in over 60 hospitals in China, with approximately 180 hospitals having access to or trialing the technology[4] - The disposable thermal vapor therapy catheter for InterVapor® has obtained sunshine procurement prices in 28 provinces and cities, with gradual implementation of local medical insurance coverage[4] - The BroncTru® disposable bronchoscopic puncture dilation catheter has been clinically applied in multiple medical centers across China since its launch in September 2023[4] - The company's InterVapor® thermal vapor treatment system is the world's first and only non-implantable medical device for treating chronic obstructive pulmonary disease (COPD) and has been commercialized in over 60 hospitals in China[33] - The InterVapor® system has been approved for commercialization in multiple regions including Europe, China, and Australia, with over 180 hospitals in China having used or trialed the technology[33] - The company's InterVapor® system has been listed on the centralized procurement platforms in 28 provinces in China, facilitating hospital procurement and pricing negotiations[33] - The Woquan® disposable endoscope nebulization microcatheter has been used in over 1,000 surgeries in the first half of 2024, primarily for airway anesthesia and nebulized drug delivery[37] - The BroncTru® disposable bronchoscopic puncture dilation catheter was approved by Zhejiang Medical Products Administration in September 2023 and has been widely adopted in top medical centers[38] - Sales of medical consumables increased by 29% to $2.3 million, driven by higher market penetration of products like InterVapor® and BroncTru in China[53] Operational Efficiency and Cost Management - The company has improved production efficiency and optimized production processes, steadily increasing capacity to meet growing business demands[5] - Cost of sales decreased by 38% to $0.8 million, primarily due to cost optimization and localization of production processes[54] - Gross margin improved to 80% from 77%, attributed to reduced production costs following the localization of InterVapor® and navigation products[55] - Administrative expenses decreased by 22% to $3.6 million, driven by cost control measures[61] - Total employee costs (excluding share-based compensation) for the reporting period were $7.9 million, down from $12.6 million in the same period in 2023[74] Financial Position and Liquidity - Total assets minus current liabilities as of June 30, 2024, were $178.002 million, down from $186.647 million at the end of 2023[8] - Cash and cash equivalents as of June 30, 2024, were $89.652 million, an increase from $72.845 million at the end of 2023[8] - Total equity attributable to owners of the parent company as of June 30, 2024, was $177.191 million, down from $185.370 million at the end of 2023[10] - Cash and bank balances, including term deposits over three months, totaled $146.3 million as of June 30, 2024, ensuring sufficient liquidity for operations and development[62] - Net cash used in operating activities was $8.8 million, a reduction from $15.9 million in the same period last year[63] - The company's capital-to-debt ratio decreased to 1.06% as of June 30, 2024, from 1.27% at the end of 2023[64] Market and Industry Trends - The global and Chinese COPD patient populations are projected to increase to 258.4 million and 109.6 million respectively by 2025[32] - Lung cancer is the most common cancer globally in 2022, with nearly 2.5 million new cases (12.4% of all cancers) and 1.8 million deaths (18.7% of all cancer deaths)[35] - China has the highest lung cancer incidence globally, with 1.06 million new cases in 2022 (22% of global cases) and 733,300 deaths (28.4% of all cancer deaths in China)[35] - The five-year survival rate for stage III lung cancer patients is 12.6%, while for stage IV patients it is only 2.9%[35] Corporate Governance and Compliance - The company complied with the Corporate Governance Code, except for the separation of Chairman and CEO roles, which are currently held by Mr. Xu Hong[68] - The company has established a high-standard quality management system in compliance with ISO13485, NMPA GMP, FDA OSR, and EU MDR regulations[43] - No significant contingent liabilities as of June 30, 2024[65] - No significant litigation or arbitration involving the company during the reporting period[73] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[70] - The company did not issue any equity securities or sell treasury shares for cash during the reporting period[71] - The company has no specific plans for major investments or acquisitions of significant capital assets or other businesses beyond the expansion strategy disclosed in the prospectus dated September 13, 2021[75] Use of Proceeds and Capital Allocation - The net proceeds from the global offering amounted to approximately HKD 1,620.1 million, with HKD 642.3 million utilized as of June 30, 2024, and an unused balance of HKD 977.8 million[76] - The company plans to allocate 29.0% of the net proceeds (HKD 469.2 million) for the development and commercialization of InterVapor®, with HKD 256.0 million remaining unused as of the reporting period[76] - 20.9% of the net proceeds (HKD 339.4 million) are allocated for the development and commercialization of RF-II, with HKD 274.2 million remaining unused as of the reporting period[76] - 18.5% of the net proceeds (HKD 299.9 million) are allocated for the R&D of other candidate products, with HKD 81.1 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for the expansion of production lines at the company's manufacturing plant, with the full amount remaining unused as of the reporting period[76] - 13.2% of the net proceeds (HKD 213.2 million) are allocated for mergers, acquisitions, or investments in new product lines, with HKD 194.0 million remaining unused as of the reporting period[76] - 9.2% of the net proceeds (HKD 149.2 million) are allocated for working capital and other general corporate purposes, with HKD 23.3 million remaining unused as of the reporting period[76] Other Income and Expenses - Total other income increased to $3.333 million in H1 2024 from $2.387 million in H1 2023, driven by higher bank interest income[21] - Other income and gains increased by $1.0 million to $3.5 million, mainly due to higher interest income[56] - Tax expense remained stable at $2 thousand in both H1 2024 and H1 2023[24] - The company received $0.1 million in government subsidies during the reporting period, compared to $0.05 million in the same period last year[50] Employee and Organizational Structure - The company had 208 employees as of June 30, 2024, with 183 in China and 25 overseas[74] - No significant investments, acquisitions, or disposals in subsidiaries, associates, or joint ventures during the reporting period[72] Dividends and Shareholder Returns - No interim dividends were declared or paid in H1 2024, consistent with H1 2023[25] - The company has not declared or paid any interim dividend for the six months ended June 30, 2024[79] Post-Reporting Period Events - The company is not aware of any significant post-reporting period events from June 30, 2024, to the date of the announcement[79] Non-IFRS Financial Measures - The company has adopted non-IFRS financial measures to provide useful information for comparing operating performance across different periods[66]