格隆汇6月3日丨百心安-B(02185.HK)公告，由公司子公司上海安通医疗科技有限公司("安通医疗")开发 的Ibers®多电极肾动脉射频消融导管系统("Iberis®RDN系统")产品上市会于2025年5月31日在第十九届东 方心脏病学会议("OCC2025会议")期间举行。 本次上市会由复旦大学附属中山医院葛均波教授、浙江大学医学院附属第二医院王建安教授、上海交通 大学医学院附属瑞金医院王继光教授、中国医学科学院阜外医院蒋雄京教授、巴塞尔大学医院 FelixMahfoud教授担任上市会主席并开场致辞。 截至本公告发布日，Iberis®RDN系统是全球唯一获批的可同时兼容TRA和经股动脉入路的RDN产品。 TRA使RDN更安全、更有效、更便宜。公司的最终目标是将门诊去肾神经手术带给世界各地的患者。 Iberis®RDN系统将由安通医疗和远大医药集团有限公司("远大医药")旗下心脑血管精准介入诊疗板块商 业主体一的凯诺威医疗科技(武汉)有限公司在中国联合推广。 北京大学人民医院刘健教授担任上市会主持，另外郑州大学第一附属医院韩战营教授、青岛市市立医院 贾楠教授、中国医学科学院阜外医院蒋雄京教授、江苏省人民医 ...

丘钛科技(01478.HK)3月摄像头模组销售合计3792.8万件 环比增长41.8% 【今日焦点】 远大医药(00512.HK)：全球创新激素纳米混悬滴眼液海外III期临床研究顺利达到临床终点 远大医药(00512.HK)公告，集团在眼科领域的合作伙伴台新药股份有限公司公布其用于抗炎镇痛的激素 纳米混悬滴眼液 APP13007 在美国开展的 II 期临床研究和两项 III 期临床研究，均已顺利达到临床终 点。根据临床结果显示，APP13007 在治疗眼科术后抗炎和镇痛方面有着显着的有效性，且安全性良 好，计划将于今年上半年向美国食品药品监督管理局(Food and Drug Administration，FDA)递交上市许 可申请(NDA)。集团拥有该产品在中国大陆、香港和澳门地区的独家开发和商业化权利。 君实生物(688180.SH)：senaparib用于晚期卵巢癌全人群一线维持治疗的III期临床研究达到主要研究终 点 君实生物(688180.SH)公布，近日，公司与南京英派药业有限公司("英派药业")合作开发的聚腺苷二磷酸 核糖聚合酶("PARP")抑制剂senaparib(产品代号：JS109/IM ...

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].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示 概 不 會就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的 任 何 損 失 承 擔 任 何 責 任。 Shanghai Bio-heart Biological Technology Co., Ltd. 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） （股 份 代 號：2185） 截 至2024年12月31日止年度的 全年業績公告； 及 提名委員會 組 成 變 動 | 財務摘要 | | | | --- | --- | --- | | | 截 至12月31日止年度 | | | | 2024年 | 2023年 | | | 人民幣千元 | 人民幣千元 | | 研發開支 | (41,300) | (111,743) | | 行政開支 | (19,740) | (52,881) | | 其他開支 | (33,913) | (30,552) | | 財務成本 | (64) | (5 ...

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].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 會 就 本 公 告 全部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Shanghai Bio-heart Biological Technology Co., Ltd. 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） （股 份 代 號：2185） 截 至2024年6月30日止六個月的 中期業績公告 | --- | --- | --- | |--------------------------------------------------|------------------------------------------------------|-----------------------------------------------| | | | | | 財務摘要 | | | | | 截 至 6 月 30 2024 年 人民幣千元 （未 經 審 ...

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].