2025 中報 2025 Interim Report 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 財務摘要 | | 5 | 管理層討論及分析 | | 16 | 其他資料 | | 26 | 中期簡明綜合損益及其他全面收益表 | | 27 | 中期簡明綜合財務狀況表 | | 29 | 中期簡明綜合權益變動表 | | 30 | 中期簡明綜合現金流量表 | | 32 | 中期簡明綜合財務資料附註 | | 45 | 釋義 | 1 上海百心安生物技術股份有限公司 二零二四年年報 公司資料 董事會 執行董事 汪立先生 （董事長、首席執行官兼總經理） 王雲磬先生 （首席財務官、董事會秘書兼聯席公司秘書） 王佩麗女士 獨立非執行董事 陳軼青先生 魯旭波先生 蔣一斐先生 審核委員會 陳軼青先生 （主席） 魯旭波先生 蔣一斐先生 薪酬委員會 魯旭波先生 （主席） 陳軼青先生 蔣一斐先生 提名委員會 蔣一斐先生 （主席） 魯旭波先生 王佩麗女士 （於2025年3月28日任命） 汪立先生 （2025年3月28日起不再擔任成員） 監事 蔡濤先生 （主席） 朱磊先生 王君毅先生 聯席公司秘書 王雲磬先生 郭兆 ...

华福证券发布研报称，经皮去肾交感神经术（RDN）是针对未控及顽固高血压器械新疗法。根据灼识 咨询，预计 2032 年中国 RDN 年市场规模超过 100 亿元人民币。该行指出，百心安 Iberis® RDN 系统 是全球唯一获批上市能兼具经桡动脉（TRA）和经股动脉双入路 RDN，先发优势显著，国内已与远大 健康、海外多国家地区联合蓝帆柏盛达成重磅战略合作；德国、法国已将 Iberis® RDN 纳入医保，当前 正为百心安商业化加速起点，建议关注百心安。 消息面上，蓝帆医疗9月19日发布公告，在公司回答调研者提问时表示，蓝帆柏盛凭借在出海领域的平 台化能力与行业知名度，与百心安就其铂睿时Iberis™多极肾动脉射频消融（RDN）系统迅速达成"出 海"合作，此前已在德国、西班牙、意大利等国完成商业化布局，且德国、法国已将其纳入医保。近 日，该系统通过新加坡卫生科学局审核，获批用于新加坡临床治疗。 智通财经APP获悉，百心安-B(02185)尾盘涨近15%，截至发稿，涨12.87%，报6.14港元，成交额1693.58 万港元。 ...

百心安-B(02185)尾盘涨近15%，截至发稿，涨12.87%，报6.14港元，成交额1693.58万港元。 消息面上，蓝帆医疗（002382）9月19日发布公告，在公司回答调研者提问时表示，蓝帆柏盛凭借在出 海领域的平台化能力与行业知名度，与百心安就其铂睿时Iberis多极肾动脉射频消融(RDN)系统迅速达 成"出海"合作，此前已在德国、西班牙、意大利等国完成商业化布局，且德国、法国已将其纳入医保。 近日，该系统通过新加坡卫生科学局审核，获批用于新加坡临床治疗。 华福证券发布研报称，经皮去肾交感神经术(RDN)是针对未控及顽固高血压器械新疗法。根据灼识咨 询，预计2032年中国RDN年市场规模超过100亿元人民币。该行指出，百心安Iberis RDN系统是全球唯 一获批上市能兼具经桡动脉(TRA)和经股动脉双入路RDN，先发优势显著，国内已与远大健康、海外多 国家地区联合蓝帆柏盛达成重磅战略合作；德国、法国已将Iberis RDN纳入医保，当前正为百心安商业 化加速起点，建议关注百心安。 ...

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8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: 上海百心安生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02185 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 236,223,322 | RMB | | 1 RMB | | 236,223,322 | | 增加 / 減少 (-) | | | -519,900 | | | RMB | | -519,900 | | 本月底結存 | | | 235,703,422 | RMB | | 1 RMB | | 235, ...

Core Viewpoint - The RDN (Renal Denervation) market is on the verge of explosive growth, driven by new guidelines and reimbursement decisions in the U.S. that include RDN as a treatment for resistant hypertension, indicating a significant commercial opportunity for the sector [3][4]. Group 1: Market Potential and Growth - The RDN market is projected to grow at a compound annual growth rate (CAGR) of 22% from 2023 to 2028, making it one of the fastest-growing segments in the medical device field [3]. - The long-term market potential for RDN in China is expected to exceed 10 billion yuan [3]. Group 2: Technological Developments - Recent FDA approvals for RDN products from Recor Medical and Medtronic mark a turning point for the technology, providing differentiated options in ultrasound and radiofrequency ablation [4]. - The introduction of the Iberis® RDN system by Bai Xin An, which is the only device approved for both transradial and transfemoral access, represents a significant innovation in the RDN space [5][6]. Group 3: Competitive Landscape - Chinese companies like Xinmai Medical, Meili Weiye, and Antong Medical have received approvals for their RDN products, showcasing the innovative capabilities of domestic firms [5]. - Blue Sail Medical, through its subsidiary Blue Sail Bosheng, has established a comprehensive international sales network, covering over 8,000 hospitals in more than 100 countries, positioning itself as a key player in the global market [6][10]. Group 4: International Expansion - The Iberis® RDN system has already seen successful clinical applications in various provinces in China and has completed its first commercial procedure in Europe [8]. - Collaborations between Chinese companies and international partners, such as Bai Xin An and Blue Sail Medical, are facilitating the entry of RDN products into overseas markets, with significant progress in countries like Germany, Spain, and Italy [9][11]. Group 5: Future Outlook - The RDN technology is set to lead a new era in hypertension treatment, with a vast unmet clinical need indicating substantial future market potential [11]. - Continuous innovation and international clinical collaborations are expected to enhance the global presence of Chinese RDN products, allowing them to capture a significant share of the high-end medical device market [11].

Core Insights - The company reported a revenue of RMB 20.862 million for the six months ending June 30, 2025, with a loss attributable to shareholders of RMB 27.213 million, representing a year-on-year increase of 5.35% [1] - The revenue during this period was primarily generated from the commercialization of RDN products, with total recognized revenue of RMB 20.90 million, compared to zero for the same period in 2024 [1] - The company's research and development expenses decreased mainly due to a reduction in depreciation and amortization expenses by RMB 2.30 million, attributed to most machinery and equipment being used for production activities [1]

Core Points - The company reported a revenue of RMB 20.862 million for the six months ending June 30, 2025, with a loss attributable to shareholders of RMB 27.213 million, representing a year-on-year increase of 5.35% [1] - The revenue during this period was primarily generated from the commercialization of RDN products, with total recognized revenue of RMB 20.90 million, compared to zero for the same period in 2024 [1] - The company's research and development expenses decreased mainly due to a reduction in depreciation and amortization expenses by RMB 2.30 million, attributed to most machinery and equipment being used for production activities [1]

Core Viewpoint - The company reported a significant increase in revenue from RDN products, marking a transition from zero revenue in the previous period to RMB 20.9 million for the six months ending June 30, 2025 [1] Revenue Summary - Revenue for the six months ending June 30, 2025, amounted to RMB 20.9 million, which includes RMB 20.5 million from product sales and RMB 0.4 million from collaborations [1] - This represents a notable increase compared to the same period in 2024, where revenue was zero [1] R&D Expenditure Summary - Research and development expenses decreased from RMB 21.8 million for the six months ending June 30, 2024, to RMB 20.1 million for the same period in 2025, a reduction of RMB 1.7 million [1] - The decrease in R&D expenses is primarily attributed to a reduction in depreciation and amortization costs by RMB 2.3 million, due to most machinery and equipment being utilized for production activities [1]

[財務摘要](index=1&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) This section provides a high-level overview of the company's financial performance for the six months ended June 30, 2025, highlighting key revenue, cost, and loss figures Financial Summary for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Revenue | 20,862 | – | | Cost of sales | (11,167) | – | | Gross profit | 9,695 | – | | Other income and gains | 764 | 1,415 | | Research and development expenses | (20,090) | (21,791) | | Selling and marketing expenses | (1,146) | – | | Administrative expenses | (9,691) | (7,084) | | Other expenses | (48) | (181) | | Finance costs | (6,648) | (23) | | Share of loss of an associate | (256) | (661) | | Loss before tax | (27,420) | (28,325) | [業務摘要](index=2&type=section&id=%E6%A5%AD%E5%8B%99%E6%91%98%E8%A6%81) This section outlines the company's significant operational achievements and product development milestones during the reporting period - The Board of Directors is pleased to announce the unaudited condensed consolidated interim results for the six months ended June 30, 2025[5](index=5&type=chunk) - The **Iberis® RDN System** received NMPA approval on February 26, 2025, for adjunctive treatment of refractory hypertension and drug-intolerant hypertension patients[6](index=6&type=chunk) - The **Iberis® RDN System** completed its first commercial procedure in Europe in February 2025[6](index=6&type=chunk) - In the first half of 2025, the company recorded **RMB 20.9 million in revenue** from the global commercialization of its second-generation Iberis® RDN System, compared to zero in the same period of 2024[6](index=6&type=chunk) - On March 27, 2025, the company successfully enrolled the first patient in the **SAKURA-SCB trial** in Japan for ischemic heart disease[6](index=6&type=chunk) [中期簡明綜合財務報表](index=3&type=section&id=%E4%B8%AD%E6%9C%9F%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) This section presents the company's interim condensed consolidated financial statements, including the statement of profit or loss, statement of financial position, and detailed notes [中期簡明綜合損益及其他全面收益表](index=3&type=section&id=%E4%B8%AD%E6%9C%9F%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E6%90%8D%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) For the six months ended June 30, 2025, the company generated revenue of RMB 20,862 thousand and a gross profit of RMB 9,695 thousand, with a net loss of RMB 26,734 thousand, a reduction from RMB 28,325 thousand in the prior year, and basic and diluted loss per share remained at RMB 0.11 Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (for the six months ended June 30) | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Revenue | 20,862 | – | | Cost of sales | (11,167) | – | | Gross profit | 9,695 | – | | Other income and gains | 764 | 1,415 | | Research and development expenses | (20,090) | (21,791) | | Selling and marketing expenses | (1,146) | – | | Administrative expenses | (9,691) | (7,084) | | Other expenses | (48) | (181) | | Finance costs | (6,648) | (23) | | Share of loss of an associate | (256) | (661) | | Loss before tax | (27,420) | (28,325) | | Income tax credit | 686 | – | | Loss for the period | (26,734) | (28,325) | | Loss attributable to owners of the parent | (27,213) | (25,830) | | Non-controlling interests | 479 | (2,495) | | Basic and diluted loss per share (RMB) | (0.11) | (0.11) | [中期簡明綜合財務狀況表](index=4&type=section&id=%E4%B8%AD%E6%9C%9F%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8) As of June 30, 2025, the company's total non-current assets were RMB 455,806 thousand, total current assets were RMB 422,611 thousand, total current liabilities were RMB 33,421 thousand, and total non-current liabilities were RMB 191,197 thousand, resulting in a net asset value of RMB 653,799 thousand, a decrease from RMB 680,533 thousand as of December 31, 2024 Interim Condensed Consolidated Statement of Financial Position (as of June 30, 2025) | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | **Non-current assets** | | | | Property, plant and equipment | 40,747 | 42,945 | | Other intangible assets | 132,952 | 137,587 | | Investment in a joint venture | 32,800 | – | | Total non-current assets | 455,806 | 434,749 | | **Current assets** | | | | Inventories | 23,133 | 18,327 | | Trade receivables | 12,168 | – | | Cash and cash equivalents | 187,380 | 202,386 | | Time deposits | 125,491 | – | | Total current assets | 422,611 | 299,027 | | **Current liabilities** | | | | Trade payables | 3 | 95 | | Contract liabilities | 18,461 | – | | Total current liabilities | 33,421 | 19,649 | | **Non-current liabilities** | | | | Redemption liabilities for shares in a subsidiary | 158,900 | – | | Total non-current liabilities | 191,197 | 33,594 | | Net assets | 653,799 | 680,533 | | Total equity | 653,799 | 680,533 | [中期簡明綜合財務報表附註](index=6&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes to the interim condensed consolidated financial statements, covering company and group information, basis of preparation, changes in accounting policies, operating segment information, composition and changes in various income and expenses, and specific details of balance sheet items, including investments in associates and aging analysis of trade receivables [1 公司及集團資料](index=6&type=section&id=1%20Company%20and%20Group%20Information) This section provides fundamental information about the company and its group structure - Shanghai Bio-Heart Biological Technology Co., Ltd. is incorporated in China, primarily engaged in the research, development, and commercialization of bioresorbable scaffold (BRS) products and second-generation renal denervation (RDN) systems[10](index=10&type=chunk) - The company's shares have been listed on the Main Board of The Stock Exchange of Hong Kong Limited since December 23, 2021[11](index=11&type=chunk) [2 編製基準](index=6&type=section&id=2%20Basis%20of%20Preparation) This section outlines the accounting standards and principles used for preparing the interim condensed consolidated financial information - The interim condensed consolidated financial information is prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and presented in RMB, with all values rounded to the nearest thousand[12](index=12&type=chunk) [3 會計政策的變動](index=6&type=section&id=3%20Changes%20in%20Accounting%20Policies) This section details any changes in accounting policies adopted during the reporting period and their impact on the financial statements - Except for the initial adoption of revised International Financial Reporting Standards, the accounting policies used to prepare the interim condensed consolidated financial information are consistent with those adopted for the annual consolidated financial statements for the year ended December 31, 2024[13](index=13&type=chunk) - The amendments to IAS 21 (Revised) regarding lack of exchangeability have no impact on the interim condensed consolidated financial information, as the currencies in which the Group transacts are exchangeable with the functional currency of the entities[14](index=14&type=chunk) [4 經營分部資料](index=6&type=section&id=4%20Operating%20Segment%20Information) This section provides information on the company's operating segments, including how revenue and non-current assets are geographically distributed - The Group has only one reportable segment, and no further analysis of this single segment is presented as the CEO reviews consolidated results for decision-making purposes[15](index=15&type=chunk) - The Group's revenue primarily comes from a major customer in mainland China, and all non-current assets are located in China, thus no geographical segment analysis is presented[15](index=15&type=chunk) [5 收益](index=7&type=section&id=5%20Revenue) This section provides a breakdown of the company's revenue by type and timing of recognition Revenue Analysis (for the six months ended June 30) | Revenue Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Sale of goods | 20,455 | – | | Collaboration income | 407 | – | | Total | 20,862 | – | | Timing of revenue recognition: | | | | Transferred at a point in time | 20,455 | – | | Transferred over time | 407 | – | | Total | 20,862 | – | [6 其他收入及收益](index=7&type=section&id=6%20Other%20Income%20and%20Gains) This section details the components of other income and gains, explaining the reasons for any significant changes Other Income and Gains Analysis (for the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Government grants | 31 | 100 | | Interest income | 733 | 674 | | Exchange gains | – | 641 | | Total | 764 | 1,415 | - Other income and gains decreased by **RMB 0.6 million** from RMB 1.4 million in the prior year to **RMB 0.8 million** in 2025, primarily due to a decrease in exchange gains[17](index=17&type=chunk) [7 除稅前虧損](index=8&type=section&id=7%20Loss%20Before%20Tax) This section itemizes the deductions and inclusions contributing to the company's loss before tax Items Deducted/Included in Loss Before Tax (for the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Cost of inventories sold | 6,151 | – | | Depreciation of property, plant and equipment | 2,397 | 3,340 | | Depreciation of right-of-use assets | 740 | 612 | | Share of loss of an associate | 256 | 661 | | Auditor's remuneration | 310 | 310 | | Amortisation of other intangible assets | 4,635 | 62 | | Interest income | (733) | (674) | | Exchange losses/(gains) | 134 | (641) | | Government grants | (31) | (77) | | Staff costs (wages and salaries) | 6,860 | 3,903 | | Staff costs (contributions to pension schemes) | 760 | 480 | [8 財務成本](index=8&type=section&id=8%20Finance%20Costs) This section provides a detailed breakdown of the company's finance costs for the reporting period Finance Costs Analysis (for the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Interest on redemption liabilities for shares in a subsidiary | 3,300 | – | | Transaction costs attributable to redemption liabilities for shares in a subsidiary | 3,187 | – | | Interest on lease liabilities | 161 | 23 | | Total | 6,648 | 23 | [9 所得稅](index=9&type=section&id=9%20Income%20Tax) This section details the company's income tax provisions, including applicable tax rates, deferred tax assets, and tax credits - No provision for enterprise income tax at a rate of 25% has been made for mainland China entities due to no estimated taxable profits for the period; Antong and Shanghai Xianjianyi Trading Co., Ltd. are recognized as small low-profit enterprises, subject to a preferential income tax rate of 20%[20](index=20&type=chunk) - No provision for Hong Kong income tax at a rate of 16.5% has been made for Hong Kong entities due to no estimated taxable profits for the period; unused tax losses and deductible temporary differences have not been recognized as deferred tax due to unpredictable future profit streams[21](index=21&type=chunk) Income Tax Credit (for the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Current income tax | – | – | | Deferred income tax | (686) | – | | Tax credit for the period | (686) | – | [10 股息](index=9&type=section&id=10%20Dividends) This section states whether any dividends were declared or paid by the company during the reporting period - The company did not declare or pay any dividends for the six months ended June 30, 2025 (2024: nil)[23](index=23&type=chunk) [11 母公司普通權益持有人應佔每股虧損](index=9&type=section&id=11%20Loss%20Per%20Share%20Attributable%20to%20Ordinary%20Equity%20Holders%20of%20the%20Parent) This section explains the calculation of basic and diluted loss per share attributable to ordinary equity holders of the parent company - The company had no potential dilutive ordinary shares outstanding during any presented period, and the weighted average number of ordinary shares calculation excludes treasury shares held in trust[24](index=24&type=chunk) Basic Loss Per Share Calculation (for the six months ended June 30) | Indicator | 2025 | 2024 | | :--- | :--- | :--- | | Loss attributable to ordinary equity holders of the parent (RMB thousands) | (27,213) | (25,830) | | Weighted average number of ordinary shares in issue for basic loss per share (thousands) | 243,417 | 243,417 | | Loss per share (RMB) | (0.11) | (0.11) | [12 物業、廠房及設備](index=10&type=section&id=12%20Property%2C%20Plant%20and%20Equipment) This section provides information on the company's property, plant, and equipment, including acquisitions and net book value - For the six months ended June 30, 2025, the Group acquired property, plant and equipment at a cost of **RMB 2,397 thousand** (2024: RMB 3,340 thousand)[26](index=26&type=chunk) - As of June 30, 2025, the net book value of property, plant and equipment was **RMB 40,747 thousand** (December 31, 2024: RMB 42,945 thousand)[26](index=26&type=chunk) [13 預付款項、其他應收款項及其他資產](index=10&type=section&id=13%20Prepayments%2C%20Other%20Receivables%20and%20Other%20Assets) This section details the company's prepayments, other receivables, and other assets, distinguishing between non-current and current portions Prepayments, Other Receivables and Other Assets (as of June 30, 2025) | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | **Non-current** | | | | Prepayments for purchase of property, plant and equipment | 26,000 | 26,023 | | Recoverable VAT – non-current | 16,442 | 20,352 | | Total | 43,135 | 47,049 | | **Current** | | | | Prepayments | 71,947 | 78,314 | | Recoverable VAT – current | 2,492 | – | | Total | 74,439 | 78,314 | - Recoverable VAT refers to input VAT expected to be recovered through tax refunds or used to offset output VAT in the future[28](index=28&type=chunk) [14 於一間聯營公司的投資](index=11&type=section&id=14%20Investment%20in%20an%20Associate) This section provides information on the company's investment in an associate, including its cost, share of post-acquisition losses, and the nature of the associate's business Investment in an Associate (as of June 30, 2025) | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Cost of investment in an associate, unlisted | 39,658 | 39,658 | | Share of post-acquisition losses | (4,305) | (4,049) | | Total | 35,353 | 35,609 | - As of June 30, 2025, the Group held a total of **22.18% equity interest** in Xinzhi Medical, which is primarily engaged in the research and development of drug-eluting balloon (DEB) products[30](index=30&type=chunk)[31](index=31&type=chunk) - This investment is accounted for using the equity method because the Group has the right to appoint one of the seven directors of Xinzhi Medical, giving it significant influence over its financial and operating policies[31](index=31&type=chunk) [15 貿易應收款項](index=11&type=section&id=15%20Trade%20Receivables) This section presents an aging analysis of the company's trade receivables Aging Analysis of Trade Receivables (as of June 30, 2025) | Aging | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Within 1 year | 12,168 | – | [管理層討論及分析](index=12&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E5%8F%8A%E5%88%86%E6%9E%90) This section provides a comprehensive discussion and analysis of the company's business operations, financial performance, and future outlook [I. 業務回顧](index=12&type=section&id=I.%20Business%20Review) This section reviews the company's core business, product pipeline, R&D progress, production capabilities, commercialization strategy, and future development prospects, focusing on BRS and RDN therapies, clinical development, and global expansion [概覽](index=12&type=section&id=Overview) This section provides a general overview of the company's strategic focus and core therapeutic areas - The company is a leading innovative interventional cardiovascular device company in China, focusing on **BRS (Bioresorbable Scaffold)** and **RDN (Renal Denervation)** therapies to address unmet medical needs in coronary artery disease and uncontrolled hypertension[33](index=33&type=chunk) [產品及管線](index=12&type=section&id=Products%20and%20Pipeline) This section outlines the company's portfolio of pipeline products at various stages of development or commercialization - As of the announcement date, the company has a pipeline of **three investigational products** at different stages of development or commercialization, including the Bioheart® BRS System, Iberis® RDN System, and Rapamycin Drug-Coated Balloon (DCB)[34](index=34&type=chunk)[35](index=35&type=chunk) [BRS在研產品](index=13&type=section&id=BRS%20Pipeline%20Products) This section focuses on the company's Bioresorbable Scaffold (BRS) pipeline product, including its development status and expected approval timeline - **Bioheart®** is a self-developed fully absorbable temporary scaffold for treating coronary artery disease, recognized as an "innovative medical device" by the NMPA in February 2017, and is expected to receive NMPA approval in the third quarter of 2026[36](index=36&type=chunk) [RDN在研產品](index=13&type=section&id=RDN%20Pipeline%20Products) This section details the company's Renal Denervation (RDN) system, including its regulatory approval and commercialization milestones - **Iberis®** is a self-developed RDN system for treating uncontrolled and resistant hypertension, approved by the NMPA on February 26, 2025, and completed its first commercial procedure in Europe in February 2025[37](index=37&type=chunk)[38](index=38&type=chunk) [DCB在研產品](index=14&type=section&id=DCB%20Pipeline%20Products) This section describes the company's new Drug-Coated Balloon (DCB) product, its design features, and clinical trial progress - The newly developed DCB is a rapamycin drug-eluting balloon catheter designed to treat in-stent restenosis, featuring anti-inflammatory effects and enhanced safety[39](index=39&type=chunk) - On March 27, 2025, the company successfully enrolled the first patient in the **SAKURA-SCB trial** in Japan for ischemic heart disease[40](index=40&type=chunk) [研究及開發](index=14&type=section&id=Research%20and%20Development) This section highlights the company's research and development capabilities, including its focus areas and intellectual property portfolio - The company's R&D team focuses on developing medical devices for coronary artery disease and hypertension, holding **over 70 registered patents** and **more than 30 pending patent applications**[41](index=41&type=chunk) [生產](index=15&type=section&id=Production) This section provides an overview of the company's production facilities and plans for capacity expansion - The company operates production facilities in Shanghai and is constructing a new manufacturing plant in Jiaxing, Zhejiang Province, expected to complete renovation by the end of 2025 and become operational in 2026[42](index=42&type=chunk) [商業化](index=15&type=section&id=Commercialization) This section outlines the company's commercialization efforts and market penetration for its second-generation RDN system - As of the announcement date, the company has successfully commercialized its **second-generation Iberis® RDN System** in multiple countries and regions, including China, France, Germany, Italy, Spain, Turkey, and Ecuador[43](index=43&type=chunk) [未來前景](index=15&type=section&id=Future%20Prospects) This section details the company's strategic goals and plans for future growth, including clinical development, market expansion, and potential collaborations - The company aims to become a globally renowned medical device platform for chronic disease management, planning to accelerate clinical development and commercialization of pipeline products, enhance sales efforts, boost R&D capabilities, expand production capacity and global footprint, and actively seek external collaborations, strategic investments, and acquisition opportunities[44](index=44&type=chunk) [II. 財務回顧](index=16&type=section&id=II.%20Financial%20Review) This section provides a detailed analysis of the company's financial performance for the six months ended June 30, 2025, covering revenue, costs, expenses, liquidity, capital expenditure, debt, and gearing ratio, noting the first-time recording of product commercialization revenue and a significant increase in finance costs due to redemption liabilities [收入](index=16&type=section&id=Revenue) This section analyzes the company's revenue sources and changes during the reporting period - For the six months ended June 30, 2025, the company's revenue was derived from the commercialization of RDN products, totaling **RMB 20.9 million** (2024: nil), comprising **RMB 20.5 million** from sale of goods and **RMB 0.4 million** from collaboration income[45](index=45&type=chunk) [銷售成本](index=16&type=section&id=Cost%20of%20Sales) This section details the cost of sales incurred by the company, primarily driven by product commercialization - For the six months ended June 30, 2025, the cost of sales was **RMB 11.2 million**, primarily due to the commercialization of the second-generation Iberis® RDN System (2024: nil)[46](index=46&type=chunk) [其他收入及收益](index=16&type=section&id=Other%20Income%20and%20Gains) This section explains the changes in other income and gains, attributing the decrease mainly to reduced exchange gains - Other income and gains decreased by **RMB 0.6 million** from RMB 1.4 million in the prior year to **RMB 0.8 million** in 2025, primarily due to a decrease in exchange gains[47](index=47&type=chunk) [行政開支](index=16&type=section&id=Administrative%20Expenses) This section analyzes the increase in administrative expenses, identifying professional service fees and depreciation as key contributing factors - Administrative expenses increased by **RMB 2.6 million** from RMB 7.1 million in the prior year to **RMB 9.7 million** in 2025, primarily due to an increase of **RMB 1.2 million** in professional service fees and **RMB 0.7 million** in depreciation expenses[48](index=48&type=chunk) [銷售及營銷開支](index=17&type=section&id=Selling%20and%20Marketing%20Expenses) This section outlines the primary components of selling and marketing expenses, including personnel costs and promotional activities - Selling and marketing expenses are primarily attributable to **RMB 0.7 million** for marketing personnel salaries and pension schemes, and **RMB 0.3 million** for RDN product marketing and promotion fees[49](index=49&type=chunk) [研發開支](index=17&type=section&id=Research%20and%20Development%20Expenses) This section details the changes in research and development expenses, attributing the decrease mainly to reduced depreciation and amortization - Research and development expenses decreased by **RMB 1.7 million** from RMB 21.8 million in the prior year to **RMB 20.1 million** in 2025, primarily due to a **RMB 2.3 million** decrease in depreciation and amortization expenses[50](index=50&type=chunk) Research and Development Expenses Breakdown (for the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Third-party contractor costs | 9,991 | 8,377 | | Employee benefit expenses | 3,730 | 4,579 | | Cost of raw materials and consumables used | 2,673 | 2,000 | | Depreciation and amortisation expenses | 1,064 | 3,337 | | Others | 2,632 | 3,498 | | Total | 20,090 | 21,791 | [財務成本](index=18&type=section&id=Finance%20Costs) This section analyzes the significant increase in finance costs, primarily due to transaction costs and interest related to redemption liabilities for subsidiary shares - Finance costs increased from **RMB 23.0 thousand** in the prior year to **RMB 6.6 million** in 2025, primarily due to **RMB 3.2 million** in transaction costs and **RMB 3.3 million** in interest attributable to redemption liabilities for shares in a subsidiary[53](index=53&type=chunk) [所得稅抵免](index=18&type=section&id=Income%20Tax%20Credit) This section reports the income tax credit recorded by the company during the reporting period - For the six months ended June 30, 2025, the company recorded an income tax credit of approximately **RMB 0.7 million** (2024: nil)[54](index=54&type=chunk) [期內虧損](index=18&type=section&id=Loss%20for%20the%20Period) This section summarizes the company's net loss for the period, indicating a reduction compared to the prior year - For the six months ended June 30, 2025, the company's net loss was **RMB 26.7 million** (2024: RMB 28.3 million), indicating a narrowed loss[55](index=55&type=chunk) [流動資金及財務資源](index=18&type=section&id=Liquidity%20and%20Financial%20Resources) This section provides an overview of the company's cash flows from operating, investing, and financing activities, as well as its overall liquidity position - For the six months ended June 30, 2025, net cash used in operating activities was **RMB 8.7 million**, primarily due to substantial research and development expenses and administrative expenses[56](index=56&type=chunk) - Net cash used in investing activities was **RMB 157.8 million**, mainly attributable to the purchase of **RMB 125.0 million** in time deposits[57](index=57&type=chunk) - Net cash generated from financing activities was **RMB 151.6 million**, primarily due to proceeds of **RMB 155.6 million** from a shareholder's subscription for equity in Zhejiang Bio-Heart Medical Technology Co., Ltd[58](index=58&type=chunk) - As of June 30, 2025, cash and cash equivalents amounted to **RMB 187.4 million**, a **7.4% decrease** from December 31, 2024, while net current assets increased to **RMB 389.2 million**, mainly due to an increase in time deposits[58](index=58&type=chunk) [資本開支](index=19&type=section&id=Capital%20Expenditure) This section details the company's capital expenditure during the reporting period, noting a decrease due to the completion of production facility acquisitions - Capital expenditure decreased from **RMB 19.8 million** in the prior year to **RMB 0.2 million** in 2025, primarily due to the completion of production facility acquisitions recorded in the previous period[59](index=59&type=chunk) [債務](index=19&type=section&id=Indebtedness) This section provides information on the company's debt position, including outstanding borrowings and changes in lease liabilities - As of June 30, 2025, the company had no outstanding borrowing balances or unutilized bank facilities[60](index=60&type=chunk) - Lease liabilities decreased from **RMB 8.3 million** as of December 31, 2024, to **RMB 7.6 million** as of June 30, 2025, primarily due to lease payments made during the reporting period[60](index=60&type=chunk) [資產負債比率](index=19&type=section&id=Gearing%20Ratio) This section analyzes the change in the company's gearing ratio, attributing the increase to redemption liabilities for subsidiary shares - The gearing ratio increased from **7.3%** as of December 31, 2024, to **25.6%** as of June 30, 2025, primarily due to an increase in redemption liabilities for shares in a subsidiary[61](index=61&type=chunk) [資本承擔](index=20&type=section&id=Capital%20Commitments) This section details the company's capital commitments, noting a decrease due to expenditures on leasehold improvements and property, plant, and equipment - As of June 30, 2025, capital commitments decreased from **RMB 71.8 million** as of December 31, 2024, to **RMB 44.0 million**, primarily due to expenditures on leasehold improvements and the acquisition of property, plant and equipment[62](index=62&type=chunk) [資產抵押](index=20&type=section&id=Pledge%20of%20Assets) This section confirms whether any of the company's assets are pledged as collateral - As of June 30, 2025, the company had no pledged assets[63](index=63&type=chunk) [或然負債](index=20&type=section&id=Contingent%20Liabilities) This section states whether the company has any significant contingent liabilities - As of June 30, 2025, the company had no material contingent liabilities[64](index=64&type=chunk) [重大投資、重大收購及出售事項](index=20&type=section&id=Material%20Investments%2C%20Material%20Acquisitions%20and%20Disposals) This section reports on any significant investment, acquisition, or disposal activities undertaken by the company during the reporting period - On December 31, 2024, an investor injected approximately **RMB 155.6 million** into Zhejiang Bio-Heart, resulting in the Group's interest in Zhejiang Bio-Heart being diluted from 100% to approximately 54.7%, which was treated as a disposal of interest in a subsidiary[65](index=65&type=chunk) - Except for the aforementioned disclosure, the company held no other material investments and made no material acquisitions or disposals of subsidiaries during the reporting period[66](index=66&type=chunk) [外匯風險](index=20&type=section&id=Foreign%20Exchange%20Risk) This section discusses the company's exposure to foreign currency risk and its management approach - The company faces foreign currency risk primarily from US dollar-denominated bank balances and currently has no foreign currency hedging policy, but management will monitor and consider hedging measures if necessary[67](index=67&type=chunk) [重大投資或資本資產之未來計劃](index=21&type=section&id=Future%20Plans%20for%20Material%20Investments%20or%20Capital%20Assets) Except as disclosed in this announcement, the Group has no other material capital expenditure plans as of the announcement date - As of the announcement date, the Group has no other material capital expenditure plans[68](index=68&type=chunk) [人力資源](index=21&type=section&id=Human%20Resources) As of June 30, 2025, the Group employed 70 full-time employees, with total employee benefit expenses of approximately RMB 10.3 million, and the company invests in staff training and development, offers competitive remuneration, and terminated its 2022 H Share Award Scheme, repurchasing and canceling related H shares - As of June 30, 2025, the Group employed **70 full-time employees**, with total employee benefit expenses of approximately **RMB 10.3 million**[69](index=69&type=chunk) - The company provides continuous education and training programs for employees and assesses salaries, promotion opportunities, and career development based on performance[70](index=70&type=chunk) - The Board of Directors terminated the 2022 H Share Award Scheme and repurchased and canceled **519,900 H shares** on August 7, 2025, resulting in a change in registered capital[73](index=73&type=chunk) [所得款項用途](index=22&type=section&id=Use%20of%20Proceeds) This section discloses the planned and actual use of the company's net proceeds from its global offering as of June 30, 2025, including multiple reallocations of funds for R&D, production facilities, and general working capital - The net proceeds from the global offering were approximately **HKD 441.69 million**[74](index=74&type=chunk) - The company changed the use of net proceeds multiple times on March 31, 2023, February 8, 2024, and October 30, 2024, including reallocating funds for DCB R&D, acquisition of production facilities, construction of production facilities and sales centers, and general corporate and working capital purposes[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) Planned and Actual Use of Net Proceeds from Global Offering (as of June 30, 2025) | Use of Net Proceeds | Revised Allocation (HKD millions) | Unutilized Amount as of January 1, 2025 (HKD millions) | Amount Utilized During Reporting Period (HKD millions) | Unutilized Amount as of June 30, 2025 (HKD millions) | Expected Timeline for Full Utilization | | :--- | :--- | :--- | :--- | :--- | :--- | | Bioheart® clinical trials, registration and commercialization | 134.37 | 19.35 | 3.78 | 15.57 | December 2027 | | Continued development of RDN pipeline product, second-generation Iberis® | 77.71 | 11.50 | 11.50 | – | Not applicable | | Acquisition of production facilities for RDN pipeline product, second-generation Iberis® | 26.37 | – | – | – | Not applicable | | Construction of production facilities and sales centers and commercial operations | 51.48 | 19.05 | 0.16 | 18.89 | December 2027 | | R&D of other pipeline products | 12.34 | – | – | – | Not applicable | | General corporate and working capital purposes | 52.17 | 6.84 | 6.84 | – | Not applicable | | R&D of DCB | 87.25 | 2.35 | 2.35 | – | Not applicable | | **Total** | **441.69** | **59.09** | **24.63** | **34.46** | | [其他信息](index=26&type=section&id=Other%20Information) This section covers additional information regarding the company's corporate governance, securities transactions, dividends, and other relevant disclosures [優先購買權](index=26&type=section&id=Pre-emptive%20Rights) The company's articles of association or Chinese law do not contain provisions for pre-emptive rights requiring the company to offer new shares proportionally to existing shareholders - The company's articles of association or Chinese law do not contain pre-emptive rights provisions[80](index=80&type=chunk) [購買、銷售或贖回上市證券](index=26&type=section&id=Purchase%2C%20Sale%20or%20Redemption%20of%20Listed%20Securities) Except for the repurchase and cancellation of H shares under the 2022 scheme, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities during the reporting period - Except for the repurchase and cancellation of H shares under the 2022 scheme, neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities during the reporting period[81](index=81&type=chunk) [中期股息](index=26&type=section&id=Interim%20Dividend) The Board of Directors resolved not to declare an interim dividend for the six months ended June 30, 2025 (2024: nil) - The Board of Directors resolved not to declare an interim dividend for the six months ended June 30, 2025[82](index=82&type=chunk) [報告期間後的後續事項](index=26&type=section&id=Subsequent%20Events%20After%20the%20Reporting%20Period) Except as disclosed in this announcement, there have been no material subsequent events for the company or the Group after the reporting period and up to the date of this announcement - There have been no material subsequent events for the company or the Group after the reporting period and up to the announcement date[83](index=83&type=chunk) [證券交易標準守則](index=26&type=section&id=Standard%20Code%20for%20Securities%20Transactions) The company has adopted the Standard Code as a code of conduct for securities transactions by directors, supervisors, and senior management, and confirms compliance throughout the reporting period - The company has adopted the Standard Code as a code of conduct for securities transactions by directors, supervisors, and senior management, and confirms compliance throughout the reporting period[84](index=84&type=chunk) [企業管治守則](index=27&type=section&id=Corporate%20Governance%20Code) The company has adopted and complied with all applicable code provisions of the Corporate Governance Code during the reporting period, with the exception of the Chairman and Chief Executive Officer roles being held by the same individual, which the Board believes benefits Group management and strategy execution - The company has adopted and complied with all applicable code provisions of the Corporate Governance Code during the reporting period[85](index=85&type=chunk) - The roles of Chairman and CEO are held by Mr. Wang, which constitutes a deviation from Code Provision C.2.1 of the Corporate Governance Code, but the Board believes this arrangement benefits Group management and strategy execution[86](index=86&type=chunk) [審閱中期業績](index=27&type=section&id=Review%20of%20Interim%20Results) The Audit Committee has reviewed the Group's interim results and adopted accounting principles and policies for the reporting period, concluding that the interim results are properly prepared and disclosed in accordance with applicable accounting standards, rules, and regulations - The Audit Committee has reviewed the Group's interim results and accounting principles, concluding that the interim results are properly prepared and disclosed[89](index=89&type=chunk) [刊發2025年簡明綜合中期業績及中期報告](index=28&type=section&id=Publication%20of%202025%20Interim%20Condensed%20Consolidated%20Results%20and%20Interim%20Report) This interim results announcement is published on the Stock Exchange website and the company's website, and the company's 2025 interim report will be published on the aforementioned websites in due course - The interim results announcement has been published on the Stock Exchange website and the company's website, and the interim report will be published in due course[90](index=90&type=chunk) [釋義](index=28&type=section&id=%E9%87%8B%E7%BE%A9) This section provides definitions for key terms and abbreviations used throughout the report to ensure consistent understanding for readers - This section provides definitions for key terms and abbreviations used in the report to ensure consistent understanding of the report's content[91](index=91&type=chunk)

Group 1 - The stock of Baixin An-B (02185) experienced a significant increase, rising over 15% during trading, reaching a high of 10.77 HKD, marking a new high in over two years, with a closing increase of over 50% the previous day [1] - As of the report, the stock price is up 7.63%, currently at 10.01 HKD, with a trading volume of 61.17 million HKD [1] Group 2 - The American Heart Association (AHA) and the American College of Cardiology (ACC) have released an updated guideline for the prevention, detection, assessment, and management of adult hypertension, which includes significant revisions from the 2017 version [1] - The new guidelines aim to provide more precise clinical practice guidance to reduce cardiovascular disease (CVD) risk, with renal denervation (RDN) being introduced as a newly recommended treatment option [1] - Additionally, there are reports that the Centers for Medicare & Medicaid Services (CMS) in the U.S. has proposed a new RDN insurance coverage plan for patients with uncontrolled hypertension, which is currently in a 30-day public comment period, with a final decision expected by October 8, 2025 [1]