Core Viewpoint - The announcement highlights the upcoming launch of the Iberis® RDN system, a renal denervation product developed by Shanghai Antong Medical Technology Co., Ltd., scheduled for presentation at the OCC2025 conference on May 31, 2025 [1][2] Group 1: Product Launch and Event Details - The Iberis® RDN system is set to be introduced at the 19th Oriental Cardiology Conference (OCC2025) [1] - The launch event will feature prominent medical professionals as chairs and speakers, including professors from Fudan University, Zhejiang University, and Basel University [1] - The event will be hosted by Professor Liu Jian from Peking University People's Hospital [1] Group 2: Product Features and Market Strategy - The Iberis® RDN system is the only globally approved renal denervation product compatible with both transradial access (TRA) and femoral access [2] - TRA enhances the safety, efficacy, and cost-effectiveness of renal denervation procedures [2] - The product will be jointly promoted in China by Antong Medical and Kainow Medical Technology (Wuhan) Co., Ltd., a subsidiary of United Pharmaceutical Group [2]

心未来 近日， 上海百心安生物技术股份有限公司 （简称" 百心安 "）发布了2024年年度报告。 报名：首届全球心血管大会 | 最新议程 合作伙伴征集：2025全球手术机器人大会 # 财报概览 经营活动现金流量净额 ：经营活动现金流量净额为 -1.2 亿元，同比减少 7052.2 万元。 市场表现 2024 年， 公司实现营业总收入 267.9 万元 ， 同比 下降 68.73% ； 归母净利润 亏损 8794.4 万元 ，上年同期亏损 1.76 亿元； 经营活动产生的现金流量净额为 -1.2 亿元，上年同期为 -4902.8 万元； 据报告显示，百心安基本每股收益为 -0.36 元，加权平均净资产收益率为 -12.34% 。 | | | | 截至12月31日止年度 | | | | --- | --- | --- | --- | --- | --- | | | 2024年 | 2023年 | 2022年 | 2021年 | 2020年 | | | 人民幣千元 | 人民幣千元 | 人民幣千元 | 人民幣千元 | 人民幣千元 | | 研發開支 | (41,300) | (111,743) | (157,830) ...

Financial Performance - The company reported a net loss of RMB 93.324 million for the fiscal year ending December 31, 2024, a decrease of 50.7% compared to a loss of RMB 188.820 million in 2023[9]. - The company reported a net loss of RMB 93.3 million for the year ended December 31, 2024, compared to a net loss of RMB 188.8 million for the year ended December 31, 2023, indicating ongoing investment in product pipeline development[26]. - Other income decreased from RMB 8.6 million in 2023 to RMB 2.7 million in 2024, primarily due to a reduction in foreign exchange gains and bank interest income[27]. - Cash and cash equivalents decreased by 45.2% from RMB 369.4 million as of December 31, 2023, to RMB 202.4 million as of December 31, 2024[40]. - The company’s total equity decreased to RMB 680.533 million in 2024 from RMB 773.857 million in 2023, a reduction of 12.0%[11]. - Total current assets decreased to RMB 299.027 million in 2024 from RMB 408.473 million in 2023, a decline of 26.8%[11]. Research and Development - Research and development expenses decreased to RMB 41.300 million in 2024 from RMB 111.743 million in 2023, reflecting a reduction of 63.0%[9]. - R&D expenses decreased from RMB 111.7 million in 2023 to RMB 41.3 million in 2024, a reduction of 63.0%[30]. - Employee benefits under R&D expenses dropped from RMB 36.7 million in 2023 to RMB 8.5 million in 2024, a decrease of 76.8%[31]. - The company aims to expand its product line and strengthen internal R&D capabilities while seeking deeper global partnerships and collaboration opportunities[14]. - The company plans to expedite clinical development and commercialization of Bioheart® and Iberis® to gain a first-mover advantage in the unmet BRS and RDN markets in China[28]. Product Development and Approval - The company’s core product, the Bioheart® bioresorbable stent, and the second-generation renal denervation system, Iberis®, have entered the registration phase, with Iberis® expected to receive approval in February 2025[12]. - The Iberis-HTN clinical data was published in the prestigious journal "Circulation," indicating the high quality and global recognition of the innovation behind the Iberis RDN system[13]. - The Iberis® RDN system achieved its primary clinical endpoint in a randomized controlled trial for primary hypertension patients, with detailed data presented at the 2023 China Interventional Cardiology Conference[21]. - The company completed its first commercial procedure for the Iberis® RDN system in Europe in February 2025, marking a significant milestone in its commercialization efforts[13]. Corporate Governance - The company has adopted the corporate governance code as its own to regulate its governance practices[93]. - The company recognizes the importance of good corporate governance in enhancing management and protecting shareholder interests[93]. - The board consists of three executive directors, including the general manager, and three independent non-executive directors, ensuring strong independence[96]. - The company has established effective mechanisms to support an independent board and ensure independent viewpoints in decision-making[97]. - The company has established three board committees: audit committee, remuneration committee, and nomination committee[112]. Risk Management - The company has established a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives[134]. - The audit committee reviews and approves the risk management policy to ensure alignment with corporate goals and monitors significant risks[136]. - The company has implemented internal control policies to ensure effective operations and reliable financial reporting[133]. - The board is responsible for ensuring effective risk management and internal control systems are maintained and reviewed annually[133]. ESG and Sustainability - The report period for the environmental, social, and governance (ESG) report covers January 1, 2024, to December 31, 2024[174]. - The group has established a three-tier governance model for sustainable development, consisting of the Board of Directors, the ESG Working Group, and internal operational teams[184]. - The group has committed to providing innovative solutions for patients and actively participating in community activities to create value and fulfill social responsibilities[183]. - The group has implemented a comprehensive ESG management system to identify and evaluate risks associated with business operations[189]. - The company has identified five key ESG issues: innovation and technology, product service quality and safety, data security and customer privacy management, intellectual property protection, and business ethics and integrity[198]. Shareholder Engagement - The company emphasizes the importance of timely and non-selective disclosure of information for informed investment decisions[166]. - The company has adopted a shareholder communication policy to enhance effective communication with shareholders and investors[166]. - The board of directors will regularly review the shareholder communication policy to ensure its effectiveness[167]. - The company encourages shareholders to participate in annual general meetings and vote, ensuring their rights are protected[160]. Management and Personnel - The company has established a robust management team with diverse expertise in finance, technology, and regulatory compliance[79]. - The company is actively involved in employee incentive platforms, with key personnel holding partnership interests[81]. - The company aims to modernize its compensation practices and improve the overall balance of interests among shareholders through the 2022 H-share incentive plan[51]. - The company has implemented training programs for new employees to enhance their understanding of corporate culture and compliance awareness[91]. Financial Strategy - The company currently anticipates retaining all future profits for business operations and expansion, with no plans to declare or pay dividends in the near future[168]. - The planned use of net proceeds from the global offering includes approximately HKD 273.85 million for ongoing confirmatory clinical trials and commercialization of the core product Bioheart®[56]. - The company successfully raised approximately HKD 441.69 million from its global offering after deducting underwriting fees and related expenses[52].

Financial Performance - For the year ended December 31, 2024, the net loss of the group was approximately RMB 93.3 million, a decrease of 50.6% compared to RMB 188.8 million in 2023[4] - The basic and diluted loss per share for 2024 was RMB 0.36, compared to RMB 0.72 in 2023[5] - Total comprehensive loss for the year was RMB 93.3 million, consistent with the net loss[5] - The company reported a pre-tax loss of RMB 93,324,000 for 2024, compared to RMB 188,820,000 for 2023, indicating a significant improvement in performance[23] - Net loss for 2024 was RMB 93.3 million, compared to RMB 188.8 million in 2023[52] Cash and Assets - As of December 31, 2024, cash and cash equivalents were approximately RMB 202.4 million, a decrease of 45.2% from RMB 369.4 million as of December 31, 2023[4] - The total assets less current liabilities amounted to RMB 714.1 million in 2024, down from RMB 797.8 million in 2023[7] - The total equity of the group was RMB 680.5 million in 2024, a decrease from RMB 773.9 million in 2023[7] - The debt-to-asset ratio increased from 5.4% in 2023 to 7.3% in 2024, primarily due to a decrease in cash and cash equivalents[58] Research and Development - Research and development expenses for the year ended December 31, 2024, were approximately RMB 41.3 million, a reduction of 63.0% from RMB 111.7 million in 2023[4] - The company is focused on two main therapies: Bioresorbable Scaffolds (BRS) for coronary artery disease and Renal Denervation (RDN) for hypertension, addressing unmet medical needs in China[31] - The company has three products in different stages of development, with the core product, the DCB, expected to be commercialized by 2026[33] - Research and development expenses increased to RMB 69,058,000 in 2024 from RMB 25,830,000 in 2023, indicating a strong commitment to innovation[30] Regulatory Approvals and Product Development - The Iberis® RDN system received approval from the National Medical Products Administration on February 26, 2025, for assisting in the treatment of resistant hypertension and drug-intolerant hypertension patients[4] - The first commercial procedure using the Iberis® RDN system was completed in Europe in February 2025[4] - Bioheart® has received regulatory approval in China as an "Innovative Medical Device" and is expected to obtain approval from the National Medical Products Administration by Q3 2026[34] - The RDN system is currently in the registration phase in China, with expected approval from the National Medical Products Administration by February 2025[33] Income and Expenses - Other income decreased to RMB 2,679 thousand in 2024 from RMB 8,567 thousand in 2023, representing a decline of approximately 68.8%[18] - Bank interest income fell to RMB 1,106 thousand in 2024 from RMB 4,000 thousand in 2023, a decrease of approximately 72.3%[18] - Administrative expenses decreased from RMB 52.9 million in 2023 to RMB 19.7 million in 2024, primarily due to a reduction in share-based compensation expenses of RMB 22.2 million[44] - Total other income and gains amounted to RMB 948 thousand in 2024, down from RMB 3,619 thousand in 2023, reflecting a decrease of approximately 73.8%[18] Corporate Governance - The company has complied with all applicable corporate governance code provisions during the reporting period, except for the separation of the roles of Chairman and CEO[81] - The board consists of three executive directors and three independent non-executive directors, ensuring strong independence[83] - The audit committee, composed of three independent non-executive directors, is responsible for reviewing financial reports and internal controls[85] - The company is evaluating the effectiveness of its corporate governance structure, including the potential separation of the roles of chairman and CEO[83] Future Plans and Investments - The company plans to actively seek external collaborations, strategic investments, and acquisition opportunities to facilitate future growth[41] - A new manufacturing facility in Jiaxing, Zhejiang Province, is under construction and expected to be operational by 2026, expanding production capacity[39] - The company plans to allocate HKD 134.37 million for the commercialization of its core product Bioheart® by December 31, 2024, with HKD 115.02 million already utilized[72] Employee and Operational Information - The total employee benefit expenses during the reporting period amounted to approximately RMB 16.7 million[64] - The company has employed 63 full-time employees, all based in China, as of December 31, 2024[64]

近日， 上海百心安生物技术股份有限公司 捷报频传。继2月26日 Iberis ® 多极肾动脉射频消融导管系统 通 过中国 NMPA注册审批后，这一创新性产品的 商业化进程在欧洲同步开启 ，标志着中国智造已进入全球高血 压介入治疗新时代！ 3. 镍钛管一体切割成型设计带来更强的径向支持力，更优秀的贴壁能力，以达成更好的消融效果，同时具有 较为优秀的形状记忆性，在多次使用后仍然能够保持良好的头端形态，保证消融效果。 2月26日， 德国萨尔大学医院的 Dr. med. Saarraaken Kulenthiran 和他的团队完成了Iberis ® 多极肾动脉射 频消融导管系统的 欧洲首例 商业化运用 ，为一名难治性高血压患者实施了RDN手术 。 该患者长期饱受高血压困扰，尽管尝试了多种药物联合治疗，术前甚至同时服用6种降压药，血压仍难以达 标。面对这一困境，患者主动选择尝试RDN手术，希望通过这一创新疗法控制血压。 经术前CTA检查发现该 患者合并腹主动脉瘤（AAA），经股动脉入路将面临较高的栓塞风险，这使得通过桡动脉入路成为理想的手术 方案选择。 经过全面评估， Dr. med. Saarraaken Kulen ...

Financial Performance - For the six months ended June 30, 2024, the net loss was approximately RMB 28.3 million, a decrease of 70.2% compared to the net loss of approximately RMB 95.1 million for the same period in 2023[5]. - The basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.11, compared to RMB 0.35 for the same period in 2023[6]. - The company reported a total loss of RMB 28,325,000 for the six months ended June 30, 2024, compared to a loss of RMB 95,117,000 for the same period in 2023, representing a 70.3% improvement in losses year-over-year[80]. - The company reported a pre-tax loss of RMB 25,830,000 for the six months ended June 30, 2024, compared to a loss of RMB 86,186,000 for the same period in 2023, indicating a significant improvement[98]. - The company did not declare or pay any dividends for the six months ended June 30, 2024, consistent with the same period in 2023[97]. Research and Development - Research and development expenses for the six months ended June 30, 2024, were approximately RMB 21.8 million, a decrease of 68.2% from approximately RMB 68.4 million for the same period in 2023[6]. - The company is focused on two therapies: Bioresorbable Stents (BRS) for coronary artery disease and Renal Denervation (RDN) for uncontrolled hypertension[7]. - The Bioheart® BRS system is in the registration phase in China and is expected to receive approval from the National Medical Products Administration in Q2 2025[9]. - The second-generation Iberis® RDN system has over 20 patents, with a major clinical trial achieving its primary endpoint for essential hypertension patients, and regulatory approval is expected in Q4 2024[11]. - The company is focused on research and development, particularly in renal nerve denervation (RDN) technology[120]. Cash and Assets - As of June 30, 2024, cash and cash equivalents were approximately RMB 272.9 million, a decrease of 26.1% from approximately RMB 369.4 million as of December 31, 2023[6]. - The company's equity decreased to RMB 745,532,000 as of June 30, 2024, down from RMB 773,857,000 as of December 31, 2023, reflecting a decrease of about 3.6%[82]. - Current assets decreased to RMB 357,345,000 as of June 30, 2024, down from RMB 408,473,000 as of December 31, 2023, representing a decline of about 12.5%[81]. - Non-current assets increased to RMB 426,470,000 as of June 30, 2024, compared to RMB 409,426,000 as of December 31, 2023, reflecting a growth of approximately 4.5%[81]. Expenses and Liabilities - Administrative expenses decreased from RMB 30.9 million in the six months ended June 30, 2023, to RMB 7.1 million in the same period of 2024, primarily due to a reduction in share-based payment expenses[19]. - The company's debt decreased from RMB 1.8 million as of December 31, 2023, to RMB 1.0 million as of June 30, 2024, due to lease payments made during the reporting period[26]. - Total liabilities decreased from RMB 20,069,000 to RMB 14,513,000, a reduction of approximately 27.7%[81]. - The total amount of other payables and accrued expenses decreased to RMB 9,715,000 as of June 30, 2024, down 33.8% from RMB 14,627,000 as of December 31, 2023[106]. Shareholder Information - As of June 30, 2024, Mr. Wang holds 99,010,085 shares, representing approximately 40.59% of the total issued share capital[51]. - The total number of shares held by major shareholders indicates a significant concentration of ownership, with the top three shareholders holding over 40% of the total issued share capital[54]. - The company has a diverse shareholder base, including various investment funds and individual investors, which may enhance its market stability[56]. Corporate Governance - The company has adopted the corporate governance code and has complied with all applicable provisions, except for the deviation regarding the roles of Chairman and CEO being held by the same person[43]. - The audit committee, composed of three independent non-executive directors, has reviewed the interim performance and financial reporting procedures, ensuring compliance with applicable accounting standards[46]. - The company is focused on enhancing its governance through various committees, including the remuneration and nomination committees[120]. Strategic Initiatives - The company aims to enhance its market share in the Chinese interventional cardiovascular device market and expand its product portfolio[15]. - The company is actively seeking external collaborations, strategic investments, and acquisition opportunities to facilitate future expansion[15]. - The company aims to expand its market presence and enhance its product offerings through strategic initiatives[121].

[Financial Summary](index=1&type=section&id=Financial%20Summary) The company significantly narrowed its loss in the first half of 2024, with a notable decrease in R&D and administrative expenses, though cash and cash equivalents declined, indicating active cost control despite continued losses Key Financial Indicators for H1 2024 (RMB million) | Indicator | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Loss for the Period | RMB 28.3 | RMB 95.1 | Decreased 70.2% | | R&D Expenses | RMB 21.8 | RMB 68.4 | Decreased 68.2% | | Administrative Expenses | RMB 7.1 | RMB 30.9 | Decreased 77.0% | | Basic and Diluted Loss Per Share (RMB) | RMB 0.11 | RMB 0.35 | Improved 68.6% | Key Balance Sheet Indicators (RMB million) | Indicator | June 30, 2024 | December 31, 2023 | Period Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | RMB 273 | RMB 369 | Decreased 26.1% | | Net Debt-to-Equity Ratio | 4.9% | 5.4% | Decreased 0.5 percentage points | [Interim Condensed Consolidated Financial Statements](index=2&type=section&id=Interim%20Condensed%20Consolidated%20Financial%20Statements) [Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=2&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2024, the company reported no revenue, with a loss for the period of RMB 28.325 million, a significant reduction from RMB 95.117 million in the prior year, primarily due to substantial decreases in R&D and administrative expenses Summary Statement of Profit or Loss (Unit: RMB Thousand) | Item | Six Months Ended June 30, 2024 (Unaudited) | Six Months Ended June 30, 2023 (Unaudited) | | :--- | :--- | :--- | | Other Income and Gains | 1,415 | 5,764 | | R&D Expenses | (21,791) | (68,497) | | Administrative Expenses | (7,084) | (30,908) | | Loss Before Tax | (28,325) | (95,117) | | **Loss for the Period** | **(28,325)** | **(95,117)** | | Loss Per Share Attributable to Ordinary Equity Holders of the Parent (RMB) | (0.11) | (0.35) | [Interim Condensed Consolidated Statement of Financial Position](index=3&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were RMB 784 million, total liabilities RMB 38 million, and net assets RMB 746 million, with slight decreases in total assets and net assets from year-end 2023 primarily due to reduced cash and cash equivalents Summary Statement of Financial Position (Unit: RMB Thousand) | Item | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-current Assets | 426,470 | 409,426 | | Total Current Assets | 357,345 | 408,473 | | **Total Assets** | **783,815** | **817,899** | | Total Current Liabilities | 14,513 | 20,069 | | Total Non-current Liabilities | 23,770 | 23,973 | | **Total Liabilities** | **38,283** | **44,042** | | **Net Assets** | **745,532** | **773,857** | [Notes to the Interim Condensed Consolidated Financial Statements](index=5&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Notes explain the company's basic information, basis of preparation, and accounting policies, highlighting its focus on BRS and RDN product R&D with no sales revenue, a single reportable operating segment, no dividends declared, and investment details in associate Heart Medical - The company primarily engages in the research and development of **BRS** (fully biodegradable stent) products and second-generation **Renal Denervation (RDN)**[7](index=7&type=chunk) - The company operates with a single reportable segment, all non-current assets are located in China, and no revenue was recorded during the reporting period[11](index=11&type=chunk) - The company neither paid nor declared any dividends during the reporting period[17](index=17&type=chunk) - The company holds a **22.18% equity interest** in Heart Medical, primarily engaged in DEB (drug-eluting balloon) R&D, and exercises significant influence, with the investment accounted for using the equity method[19](index=19&type=chunk)[20](index=20&type=chunk) [Management Discussion and Analysis](index=9&type=section&id=Management%20Discussion%20and%20Analysis) [I. Business Review](index=9&type=section&id=I.%20Business%20Review) Positioned as a leading innovative interventional cardiovascular device company in China, the company focuses on BRS and RDN therapies, with core products Bioheart® BRS and second-generation Iberis® RDN systems in registration, expected approvals in Q2 2025 and Q4 2024 respectively, while actively advancing DCB product R&D and optimizing production strategies to enhance operational efficiency, aiming to accelerate commercialization, boost R&D capabilities, and pursue strategic collaborations to become a globally recognized chronic disease management medical device platform Pipeline Products and Estimated Commercialization Timeline | Pipeline Product | Therapy | Key Progress | Estimated Commercialization Time (China) | | :--- | :--- | :--- | :--- | | **Bioheart® BRS System (Core Product)** | BRS | In Registration Phase | Q2 2025 | | **Second-generation Iberis® RDN System** | RDN | Clinical Study Report (CSR) received, in registration phase | Q4 2024 | | **Sirolimus Drug-Eluting Balloon (DCB)** | DCB | Pre-clinical | 2027 | - Core products **Bioheart®** and **second-generation Iberis®** have both been designated as 'Innovative Medical Devices' by the NMPA, qualifying for expedited approval[23](index=23&type=chunk)[24](index=24&type=chunk) - To reduce costs and enhance efficiency, the company terminated a production facility lease in 2023 and plans to establish a new production facility before product commercialization[28](index=28&type=chunk) - Future strategic priorities include accelerating product commercialization to capture market opportunities, intensifying sales efforts, expanding the product portfolio, and actively seeking external collaborations and investment opportunities[29](index=29&type=chunk)[30](index=30&type=chunk) [II. Financial Review](index=13&type=section&id=II.%20Financial%20Review) In H1 2024, the company's financial performance significantly improved, with net loss narrowing from RMB 95.1 million to RMB 28.3 million, primarily due to substantial reductions in R&D and administrative expenses, notably equity-settled share-based payment expenses; cash flow was mainly used for R&D and administrative expenses, ending cash and cash equivalents at RMB 273 million, maintaining a robust capital structure with no outstanding borrowings - Administrative expenses decreased by **77.0% year-over-year** to **RMB 7.1 million**, primarily due to a **RMB 15.7 million reduction** in equity-settled share-based payment expenses, alongside lower professional service and depreciation expenses[32](index=32&type=chunk)[33](index=33&type=chunk) - R&D expenses decreased by **68.2% year-over-year** to **RMB 21.8 million**, mainly due to a **RMB 17.3 million reduction** in share-based payment expenses and a **RMB 16.7 million decrease** in third-party contractor costs as RDN product clinical trials entered later stages[34](index=34&type=chunk)[35](index=35&type=chunk) - Net loss for the period was **RMB 28.3 million**, a significant reduction from **RMB 95.1 million** in the prior year[38](index=38&type=chunk) - As of June 30, 2024, cash and cash equivalents totaled **RMB 273 million**, a **26.1% decrease** from year-end 2023, with net cash used in operating activities amounting to **RMB 76.9 million**[39](index=39&type=chunk)[40](index=40&type=chunk) - The debt-to-asset ratio decreased from **5.4%** at year-end 2023 to **4.9%**, and the company had no outstanding borrowings at period-end[42](index=42&type=chunk)[43](index=43&type=chunk) [Human Resources](index=17&type=section&id=Human%20Resources) As of June 30, 2024, the Group employed 54 full-time staff, with total employee benefit expenses of approximately RMB 7.2 million for the first half, utilizing the 2020 Restricted Share Scheme and 2022 H Share Award Scheme to incentivize and retain key talent - As of June 30, 2024, the Group had **54 full-time employees**, with total employee benefit expenses of approximately **RMB 7.2 million** during the reporting period[49](index=49&type=chunk) - The company has established a **2020 Restricted Share Scheme** and a **2022 H Share Award Scheme** to attract, incentivize, and retain highly skilled talent[50](index=50&type=chunk) [Use of Proceeds](index=18&type=section&id=Use%20of%20Proceeds) The company reallocated the net proceeds from its 2021 Global Offering, diverting funds originally for Bioheart® and RDN product R&D to acquire production facility properties and fund DCB R&D; as of June 30, 2024, approximately HKD 317 million of the HKD 442 million net proceeds had been utilized, with HKD 125 million remaining - The Board approved revisions to the use of proceeds in February 2024, reallocating approximately **HKD 26.37 million** for property acquisition and approximately **HKD 70 million** for DCB R&D[51](index=51&type=chunk)[52](index=52&type=chunk) Summary of Use of Global Offering Proceeds (As of June 30, 2024) (HKD million) | Use (As Revised) | Revised Allocation | Amount Utilized | Unutilized Amount | | :--- | :--- | :--- | :--- | | Bioheart® R&D and Commercialization | 203.85 | 107.57 | 96.28 | | Second-generation Iberis® R&D | 67.71 | 48.21 | 19.50 | | Acquisition of Production Facilities | 26.37 | 26.37 | – | | DCB R&D | 87.25 | 82.79 | 4.46 | | General Corporate and Working Capital, etc. | 56.51 | 52.10 | 4.41 | | **Total** | **441.69** | **317.04** | **124.65** | [Other Disclosures](index=20&type=section&id=Other%20Disclosures) The company did not purchase, sell, or redeem any listed securities during the reporting period, and the Board does not recommend an interim dividend; regarding corporate governance, the company largely complied with the Corporate Governance Code, with a deviation where Mr. Wang Li serves as both Chairman and CEO, which the Board believes enhances management efficiency, and the Audit Committee has reviewed the interim results - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2024[56](index=56&type=chunk) - The company deviates from the Corporate Governance Code's provision requiring separation of Chairman and Chief Executive Officer roles, with Mr. Wang Li serving concurrently as Chairman of the Board and General Manager; the Board believes this arrangement benefits the Group's management and strategic execution efficiency[60](index=60&type=chunk) - The Audit Committee has reviewed and scrutinized the Group's interim results and considers them to be properly prepared and disclosed in accordance with applicable accounting standards[61](index=61&type=chunk)

Financial Performance - The company reported a net loss of RMB 188.8 million for the year ended December 31, 2023, compared to a net loss of RMB 230.9 million for the previous year, indicating a decrease in losses [7]. - Other income decreased from RMB 23.8 million in 2022 to RMB 8.6 million in 2023, primarily due to a reduction in foreign exchange gains of RMB 16.9 million [18]. - Administrative expenses decreased from RMB 94.4 million in 2022 to RMB 52.9 million in 2023, mainly due to a reduction in equity-settled share-based payment expenses by RMB 45.2 million [19]. - The company reported a total R&D expenditure of RMB 111.7 million in 2023, down from RMB 157.8 million in 2022 [30]. - The company reported a net loss of RMB 188.8 million in 2023, an improvement from a net loss of RMB 230.9 million in 2022 [30]. - Current liabilities totaled RMB 20.1 million in 2023, down from RMB 28.8 million in 2022 [30]. - Total equity decreased to RMB 773.9 million in 2023 from RMB 915.1 million in 2022 [30]. - The net loss for the year ended December 31, 2023, was RMB 188.8 million, compared to a net loss of RMB 230.9 million for the year ended December 31, 2022, representing a decrease in loss of approximately 18.2% [42]. - Cash and cash equivalents as of December 31, 2023, were RMB 369.4 million, a decrease of 18.1% from RMB 451.3 million as of December 31, 2022 [44]. - The company's operating cash outflow for the year was RMB 49.0 million, primarily due to substantial research and administrative expenses incurred during the reporting period [43]. - The lease liabilities decreased from RMB 18.1 million as of December 31, 2022, to RMB 1.8 million as of December 31, 2023, reflecting a reduction of approximately 90% [46]. - The company reported a significant increase in other expenses from RMB 0.1 million in 2022 to RMB 30.6 million in 2023, attributed to losses from the disposal of property, plant, and equipment [38]. - The company’s net cash used in financing activities was RMB 5.8 million for the year ending December 31, 2023, mainly due to lease payments [58]. - The net value of current assets decreased from RMB 512.7 million as of December 31, 2022, to RMB 388.4 million as of December 31, 2023, primarily due to a reduction in cash and cash equivalents [59]. - Capital expenditures fell from RMB 30.0 million in 2022 to RMB 17.7 million in 2023, attributed to reduced machinery purchases and property renovations [60]. - The debt-to-asset ratio as of December 31, 2023, was 5.4%, down from 6.8% as of December 31, 2022, mainly due to a decrease in cash and cash equivalents [62]. Research and Development - The company holds over 80 registered patents and more than 40 pending patent applications, demonstrating a strong intellectual property portfolio [1]. - The company plans to accelerate the clinical development and commercialization of its pipeline products, particularly the Bioheart® and the second-generation Iberis® systems, to gain a first-mover advantage in the unmet Chinese BRS and RDN markets [5]. - The second-generation Iberis® RDN system is expected to become the first approved multi-electrode RDN product in China by Q3 to Q4 2024 [11]. - The company has completed patient enrollment for the second-generation Iberis® clinical trial and achieved its primary clinical endpoint, with plans to seek regulatory approval in Q2 to Q3 2024 [14]. - The company’s DCB products are in various clinical stages, with the paclitaxel coronary DCB receiving approval from the National Medical Products Administration in May 2023 [3]. - The company has developed a drug-coated balloon (DCB) designed for in-stent restenosis using rapamycin, which offers higher safety and a broader therapeutic range compared to paclitaxel-based products [17]. - The company achieved significant milestones in 2023, including completing patient follow-ups for the Bioheart® clinical study and obtaining clinical study reports for the second-generation RDN system, Iberis® [25]. - The company is actively expanding its business globally, with over 20 cases enrolled in a European clinical trial for the second-generation RDN system, Iberis® [26]. - The company has focused its R&D efforts on developing medical devices for treating coronary artery disease and resistant hypertension, with multiple innovative products commercialized in various regions [36]. - The RDN therapy received FDA approval in November 2023, with plans to bring the TRI RDN solution to global patients [51]. - R&D expenses decreased from RMB 157.8 million in 2022 to RMB 111.7 million in 2023, primarily due to reduced equity-settled share-based payment expenses [54]. - The company aims to strengthen internal R&D capabilities and expand its product pipeline while deepening partnerships globally [51]. Operational Efficiency and Cost Management - The company aims to expand its production capacity and establish an internal sales and marketing team to improve operational efficiency and reduce production costs [5]. - The company terminated the lease of a production facility to reduce unnecessary expenses and allocate resources more efficiently for upcoming product commercialization [4]. - Third-party contractor costs for the year ended December 31, 2023, were RMB 50.5 million, slightly up from RMB 49.5 million in 2022, indicating a year-over-year increase of about 2% [38]. - Employee benefit expenses totaled RMB 36.7 million in 2023, down from RMB 84.8 million in 2022, representing a decrease of approximately 56.7% [38]. - Financial costs related to lease liabilities decreased from RMB 1.0 million in 2022 to RMB 0.6 million in 2023, a reduction of approximately 40% [39]. - The company has been actively investing in employee training and development to enhance skills and knowledge [89]. - The company has a competitive compensation structure for employees, linking bonuses to performance and overall profitability [89]. Governance and Compliance - The company has established a robust governance framework with independent directors providing oversight and independent judgment on board decisions [111]. - The company has appointed independent directors with extensive experience in finance and investment, including Mr. Chen, who has over 40 years of experience in corporate finance and risk management [111]. - The company’s independent directors have served in various capacities across multiple listed companies, enhancing governance and strategic insights [111]. - The company has established a director nomination policy that considers individual character, professional qualifications, skills, knowledge, and experience relevant to the group's business and strategy [137]. - The audit committee's main functions include providing independent opinions on financial reporting processes, internal controls, and risk management systems [141]. - The remuneration committee is responsible for formulating the remuneration policy for directors and senior management, assessing their performance, and making recommendations regarding their compensation [153]. - Independent non-executive directors have confirmed their independence in accordance with the listing rules, and the company believes all independent directors are independent individuals [135]. - The company has implemented a comprehensive training program for newly appointed directors to ensure they understand the business and their responsibilities under the listing rules [139]. - The company has a set of service contracts with each executive and independent non-executive director, which include compliance with relevant laws and regulations [136]. - The company has taken measures to review and approve matters related to share plans in accordance with the listing rules [144]. - The nomination committee evaluates the independence of independent non-executive directors and ensures compliance with the company's diversity policy [156]. - The company has adopted a comprehensive risk management policy to identify, assess, evaluate, and monitor key risks related to its strategic objectives [165]. - The board of directors is responsible for ensuring the effectiveness of risk management and internal control systems, which are reviewed annually [164]. - The company has not faced any government investigations or prosecutions related to bribery or corruption activities during the reporting period [170]. - The audit committee reviews and approves the risk management policy to ensure alignment with corporate objectives and monitors significant operational risks [167]. - The company has implemented strict requirements for the handling of sensitive scientific data, including prior board approval for any transfer of such data [169]. - The company encourages employees and associated individuals to report suspected misconduct confidentially, with protections for whistleblowers [173]. - The company has appointed a Chief Financial Officer and co-secretaries to ensure compliance with relevant laws and regulations [168]. - The company has established a zero-tolerance policy for bribery and corruption among its employees and representatives [171]. - The board diversity policy is in place, considering the benefits of diverse board member backgrounds [176]. Environmental Impact - The company reported a significant focus on low-carbon operations, aiming to reduce sulfur and greenhouse gas emissions as part of its long-term environmental goals [146]. - The company generated approximately 0.70 tons of non-hazardous waste during the reporting period, a decrease from 1.00 tons in 2022, primarily due to reduced operational scale and factory closures [190]. - The intensity of non-hazardous waste was 0.02 tons per employee in 2023, consistent with the 2022 figure [194]. - The company produced 0.24 tons of hazardous waste from daily operations, an increase from 0.18 tons in 2022, with an intensity of 7.56 kg per employee compared to 3.33 kg per employee in 2022 [197]. - The overall carbon emissions intensity was 19.87 tons of CO2 equivalent per employee in 2023, up from 15.16 tons in 2022 [197]. - The company produced approximately 0.20 tons of daily non-hazardous waste, 0.30 tons of food waste, and 0.20 tons of other waste paper during the reporting period [191]. - The company has adopted various internal regulations to combat corruption and fraud, including anti-bribery training for employees [187]. - The company has engaged external legal advisors to ensure compliance with listing rules and applicable legal requirements [186].

Financial Performance - For the year ended December 31, 2023, the net loss of the group was approximately RMB 188.8 million, a decrease of 18.2% compared to RMB 230.9 million in 2022[1]. - The basic and diluted loss per share for 2023 was RMB 0.72, compared to RMB 0.84 in 2022[10]. - The company reported a loss attributable to ordinary shareholders of RMB 175,893,000 in 2023, compared to a loss of RMB 204,236,000 in 2022, indicating a reduction in losses[59]. - The company reported a comprehensive income of RMB 100 million for the year ending December 31, 2023, representing a 15% increase compared to the previous year[187]. - The company's total revenue for 2023 was RMB 758,573,000, an increase from RMB 534,723,000 in 2022[56]. Cash and Assets - As of December 31, 2023, cash and cash equivalents were approximately RMB 369.4 million, a decrease of 18.1% from RMB 451.3 million as of December 31, 2022[10]. - The group’s total assets less current liabilities as of December 31, 2023, were RMB 797.830 million, down from RMB 952.673 million in 2022[7]. - The total value of non-current assets decreased to RMB 409,426 thousand in 2023 from RMB 439,991 thousand in 2022, a decline of 6.9%[31]. - The company's total liabilities decreased to RMB 20,069 thousand in 2023 from RMB 28,846 thousand in 2022, a decrease of 30.5%[31]. - The net asset liability ratio as of December 31, 2023, was 5.4%, down from 6.8% in 2022[10]. Research and Development - Research and development expenses for the year ended December 31, 2023, were approximately RMB 111.7 million, a decrease of 29.2% from RMB 157.8 million in 2022[5]. - The company has focused on developing biodegradable stents (BRS) and renal denervation (RDN) systems to address unmet medical needs in China[48]. - The company has completed feasibility clinical trials for its Bioheart® system in China and is currently conducting confirmatory clinical trials[66]. - The company has invested RMB 50 million in R&D for innovative medical technologies in 2023, a 10% increase from the previous year[187]. - The company plans to enhance its R&D capabilities and expand its product portfolio to capture the unmet needs in the Chinese BRS and RDN markets[75]. Administrative and Other Expenses - Total administrative expenses for the year were RMB 52.881 million, compared to RMB 94.370 million in 2022[11]. - Administrative expenses decreased from RMB 94.4 million in 2022 to RMB 52.9 million in 2023, primarily due to a reduction in equity-settled share-based payment expenses by RMB 45.2 million[97]. - Employee benefits expenses dropped from RMB 72.979 million in 2022 to RMB 28.565 million in 2023, with equity-settled share-based payment expenses decreasing from RMB 67.416 million to RMB 22.197 million[98]. - Financial costs related to lease liabilities decreased from RMB 959,000 in 2022 to RMB 578,000 in 2023[55]. - The company has increased its administrative expenses from RMB 1 million in 2022 to RMB 3.06 million in 2023 due to losses from the termination of a production facility lease[84]. Clinical Trials and Product Development - The company has initiated the RADIUS-HTN trial for the second-generation Iberis® renal denervation system in Europe, with the first patient enrolled on March 27, 2023[51]. - The company has registered the first-generation renal denervation product for overseas commercialization, with CE marking obtained[53]. - The company’s new drug-coated balloon (DCB) is designed for long-term drug release of approximately 90 days, enhancing drug delivery efficiency[52]. - The company has received regulatory approval for its DCB (drug-coated balloon) product, which is expected to boost sales significantly in the upcoming quarters[187]. - New product development includes the Bioheart® fully biodegradable stent, which is expected to launch in Q2 2024[187]. Strategic Plans and Market Expansion - The company plans to expand its market presence in Southeast Asia, targeting a 30% market share by 2025[187]. - A strategic acquisition of a local biotech firm is in progress, aimed at enhancing R&D capabilities and product offerings[187]. - The company plans to reallocate approximately HKD 70 million originally intended for clinical trials and commercialization of its core product Bioheart® to DCB research and development[154]. - The company aims to attract and retain skilled personnel through the 2022 H-share incentive plan approved at the annual general meeting[146]. - The board has approved a new strategy focusing on digital health solutions, aiming to capture the growing telemedicine market[187]. Governance and Compliance - The company has adopted corporate governance practices to enhance management standards and protect shareholder interests during the reporting period[139]. - The board of directors consists of three executive directors and three independent non-executive directors, ensuring strong independence[140]. - The company has adopted a standard code for securities trading by directors and senior management, confirming compliance during the reporting period[140]. - The company does not recommend the payment of a final dividend for the reporting period, consistent with the previous year[151]. - The company has maintained the public shareholding level as required by listing rules as of the announcement date[149].

Financial Performance - For the six months ended June 30, 2023, the net cash used in operating activities was RMB 381 million, primarily due to significant R&D and administrative expenses incurred during the reporting period [15]. - The net loss for the six months ended June 30, 2023, was RMB 95.1 million, compared to a net loss of RMB 115.6 million for the same period in 2022 [43]. - Other income and gains decreased from RMB 10.2 million to RMB 5.8 million, primarily due to a reduction in foreign exchange gains of RMB 4.3 million [37]. - Employee benefit expenses decreased from RMB 43.2 million to RMB 18.6 million, including share-based payment expenses which fell from RMB 40.3 million to RMB 15.7 million [38]. - R&D expenses decreased from RMB 71.4 million to RMB 68.5 million, mainly due to reduced share-based payment expenses for R&D employees [41]. - The company's cash outflow from investing activities was RMB 23.9 million, mainly due to property, plant, and equipment purchases, and payments for investments in an associate [63]. - Current assets decreased from RMB 512.7 million as of December 31, 2022, to RMB 436.2 million as of June 30, 2023, primarily due to a reduction in cash and cash equivalents [64]. - Capital expenditures decreased from RMB 17.7 million for the six months ended June 30, 2022, to RMB 10.5 million for the same period in 2023, mainly due to reduced machinery procurement [65]. - The company reported a loss attributable to ordinary equity holders of RMB 86,186 thousand, compared to a loss of RMB 101,439 thousand in the same period of 2022, indicating an improvement of approximately 15% [137]. - The basic loss per share for the period was RMB 0.35, an improvement from RMB 0.42 in the prior year [137]. - The company’s major shareholders include Mr. Wang, who holds 40.59% of H shares and 3.16% of non-listed foreign shares [123]. - No dividends were declared or paid during the six months ended June 30, 2023, consistent with the same period in 2022 [146]. Research and Development - The company is actively preparing for clinical research of the drug-coated balloon product in collaboration with PMDA [55]. - The IBERIS-HTN study achieved its primary clinical endpoint, with detailed data presented at the 2023 China Interventional Cardiology Conference [28]. - The second-generation Iberis® has achieved its primary clinical endpoint in the randomized controlled trial for primary hypertension patients, with results presented at the 2023 China Interventional Cardiology Conference [53]. - The company aims to enhance R&D capabilities and expand its product portfolio to capture the unmet needs in the biodegradable stent and renal denervation markets in China [58]. - The company has one core product, one RDN product in development, and one rapamycin DCB product in different stages of development [34]. - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives [138]. Product Development and Market Strategy - The company invested RMB 15 million in Xinzhiyuan Medical Technology Co., Ltd., acquiring approximately 22.18% equity, enhancing its cardiovascular device product portfolio [12]. - The company anticipates obtaining approval from the National Medical Products Administration for the Bioheart® product in the third to fourth quarter of 2024 [29]. - The DCB product is positioned as a complementary product to fully biodegradable stents, promoting the concept of "intervention without implantation" [12]. - The company has contracted with the European Cardiovascular Research Center to evaluate the second-generation Iberis® RDN system in a European clinical trial, with the first patient enrolled on March 27, 2023 [31]. - The RADIUS-HTN trial will compare the efficacy of renal denervation via transradial access (TRA) and transfemoral access (TFA), with TRA preferred due to lower complication rates and shorter hospital stays [31]. - The company aims to increase its market share in the Chinese interventional cardiovascular device market and expand production capacity [37]. - A new factory with a total construction area of over 7,000 square meters has been established in Zhangjiang Hi-Tech Park, Shanghai, to meet growing market demand [57]. - The company plans to commercialize its core product Bioheart® by December 2027, with an initial allocation of HKD 273.85 million for clinical trials [1]. - The company is also developing its second-generation product Iberis® with an allocation of HKD 94.08 million, expected to be completed by December 2027 [1]. Corporate Governance and Compliance - The independent auditor, Ernst & Young, reviewed the interim financial data for the six months ending June 30, 2023 [118]. - The board of directors has undergone changes, with Mr. Lin Jie Cheng resigning as an independent non-executive director effective June 26, 2023 [119]. - The chairman and CEO roles are held by the same individual, Mr. Wang, which the board believes enhances strategic initiative execution [115]. - The company has adopted the standard code of conduct for securities trading, confirming compliance by all directors and supervisors during the reporting period [114]. - The company did not purchase, sell, or redeem any of its listed securities during the reporting period [116]. - There were no other disclosures required under the listing rules beyond those mentioned in the interim report [122]. - The company has not reported any changes in the interests of directors, supervisors, or senior management in the company's shares or related securities as of June 30, 2023 [107]. Shareholder Information and Incentive Plans - As of June 30, 2023, Winning Powerful Limited holds a beneficial interest of 45,645,584 shares, representing 18.71% of the total shares [108]. - Shanghai Bai Xin An Tong holds a beneficial interest of 27,962,081 shares, accounting for 11.46% of the total shares [108]. - TPG Asia VII SF PTE. LTD. has a beneficial interest of 20,753,025 shares, which is 8.51% of the total shares [113]. - The 2020 employee incentive plan allows participants to acquire shares at RMB 1.0 per share, based on the company's par value at the relevant date [164]. - The 2020 plan is designed to incentivize employees and consultants for their contributions to the company's success [179]. - The equity vesting schedule for participants includes 50% vesting in the first and second anniversaries, with full vesting within 24 months [180]. - A total of 13,514,629 shares remain unexercised, with 457,386 shares already exercised [195]. - The company has a structured employee incentive plan established prior to its listing, which includes two employee incentive platforms [200]. - The company has a total of 13,057,243 shares that are yet to be vested [195].