Group 1 - The article discusses the 2024 Global Medical Technology Innovation Awards and the 2024 Global Medical Technology Newcomer Awards, with a ceremony held on June 28 for companies included in the list for the first half of 2024 [1] - Companies that wish to participate in the 2025 awards ceremony on July 17 must fill out a registration form, and failure to participate will be considered as forfeiting the opportunity [1] - The awards are free of charge, but companies are responsible for their own travel expenses [1] Group 2 - The list of awarded companies for the 2024 Global Medical Technology Innovation Awards includes: Mindray Medical, MicroPort Medical, HeartSky Medical, Qiming Medical, Zhenyi Medical, and others [3] - The article provides a link for awarded companies to fill out their information for the awards [4] - The article encourages companies to actively participate in upcoming events organized by the company, including the Second Global Medical Technology Conference on July 17, 2025, and the Third Global Surgical Robot Conference from September 3-5, 2025 [5]

中证智能财讯 启明医疗-B（02500）4月29日披露2024年度报告。报告期内，公司实现营业总收入5.09亿元，同比下降30.51%；归母净利润亏损7.14亿元，上 年同期亏损7.04亿元；经营活动产生的现金流量净额为2373.9万元，上年同期为-6.1亿元；据报告显示，启明医疗-B基本每股收益为-1.63元，加权平均净资 产收益率为-27.5%。 以4月29日收盘价计算，启明医疗-B目前市净率（TTM）约0.47倍，市销率（TTM）约2.23倍。 市净率(LF)历史分位(%) 001 900 93d3 80-78 80 70 63-94 60 50 2012 44:22 40 3745 30 20 10 11606 0 2019-12-37 1 1-12-37 J-12-37 2n- 制图数据来自恒生聚源数据库 100 + 93:51- 83:41 % 50 58-54 32.19 0 -23:31 -30.51 -50 -100 -150 -200 2022 2023 2019 2020 2021 2024 -○- 营业总收入同比增长率 -○- 归母净利润同比增长率 制图数据来自恒生聚源数据库 总营收、 ...

Financial Performance - In 2024, the company achieved a total revenue of RMB 470 million, with a stable gross margin of 78.1%[9] - For the fiscal year ending December 31, 2024, the company reported revenue of RMB 470.833 million, a decrease of 4.2% compared to RMB 491.373 million in 2023[16] - The company recorded a pre-tax loss of RMB 740.713 million, slightly higher than the loss of RMB 735.340 million in 2023[16] - The net loss attributable to the parent company was RMB 714.307 million, compared to RMB 703.754 million in the previous year, indicating a marginal increase in losses[16] - The gross profit for the same period was RMB 367.746 million, down from RMB 389.205 million in 2023, reflecting a decline of 5.5%[16] - The company's commercialization profit margin increased from 9.3% for the year ended December 31, 2023, to 20.7% for the year ended December 31, 2024, enhancing overall profitability and long-term value creation[45] - The company's sales cost for the year ended December 31, 2024, was RMB 103.1 million, an increase of 0.9% from RMB 102.2 million for the year ended December 31, 2023[54] - The group's gross profit decreased by 5.5% from RMB 389.2 million for the year ended December 31, 2023, to RMB 367.7 million for the year ended December 31, 2024[55] - Other income and gains fell by 84.1% from RMB 241.6 million for the year ended December 31, 2023, to RMB 38.5 million for the year ended December 31, 2024, due to the absence of fair value adjustments related to the acquisition of Nuo Cheng[56] Revenue Sources and Market Expansion - The company's international revenue reached RMB 82.5 million, a year-on-year increase of 13.5%, with overseas revenue accounting for 17.5% of total revenue[10] - Overseas revenue reached RMB 82.5 million, representing a year-on-year growth of 13.5%, with international revenue contributing 17.5% of total sales[22] - The company expanded its product coverage to 13 new countries, bringing the total to nearly 70 countries and regions[10] - The company has covered over 650 hospitals and participated in over 90 third-party conferences, hosting more than 100 self-organized meetings, reaching over 5,500 experts with a total viewership of 2 million[47] - VenusA series products accounted for 80.7% of total revenue for the year ended December 31, 2024, while VenusP-Valve contributed 18.5%[53] Research and Development - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases, with four TAVR products already commercialized[23] - The company has invested RMB 341.2 million and RMB 524.9 million in R&D for the years ending December 31, 2024, and December 31, 2023, respectively[40] - Clinical trials for new products such as Venus-PowerX and Venus-Vitae are progressing steadily, with positive feedback from international experts[21] - Key clinical trials for Venus-PowerX and Venus-Vitae have commenced, marking significant milestones in product development[11] - VenusP-Valve has successfully enrolled patients in the IDE critical clinical trial in the U.S., further validating its safety and effectiveness[12] Clinical Trials and Product Development - Cardiovalve's European clinical research has progressed smoothly, with nearly 120 cases enrolled, demonstrating excellent safety and efficacy[12] - Cardiovalve's clinical trials are progressing steadily, with nearly 120 patients enrolled in the Target CE European pivotal clinical trial across over 30 renowned cardiovascular centers in Germany, Italy, Spain, the UK, and Canada[37] - 93.7% of patients experienced a reduction in tricuspid regurgitation to mild or less after treatment with Cardiovalve, demonstrating its safety and efficacy[37] - VenusA-Deluxe received NMPA approval in November 2024, enhancing the delivery system and reducing valve folding rates during loading[27] - VenusP-Valve's 5-year follow-up data showed zero patient deaths or reoperations, with 94% of patients classified as NYHA I/II post-surgery[29] Governance and Internal Control - The company is undergoing internal control and governance improvements, aiming to meet the resumption conditions by March 12, 2025[13] - The company has established a strengthened internal audit and compliance department to oversee compliance and internal control implementation, reporting directly to the audit committee[116] - A management committee consisting of three directors has been formed to supervise the internal control functions of the group[116] - The company has implemented a risk management framework to ensure transparency and performance in risk management across all departments[117] - The audit committee oversees the overall risk management related to the company's operations, ensuring alignment with corporate goals[113] Strategic Outlook and Challenges - The company plans to optimize market strategies and continue commercializing its R&D pipeline to ensure long-term stable growth[13] - The company aims to maintain stability and growth while maximizing shareholder value through regular review and management of its capital structure[85] - The company is facing challenges due to a complex external environment, including geopolitical uncertainties and high federal fund rates, while maintaining its leading position in the domestic structural heart disease industry[99] - The company is restructuring its product pipeline based on cash flow and prioritizing clinical progress while exploring overseas product models[100] - The company may face significant risks related to product development, including potential future losses and the impact of regulatory approvals on commercialization[101] Management and Corporate Governance - The company has appointed new supervisory board members to strengthen governance and oversight[145][146] - The management team includes experienced professionals with extensive backgrounds in finance and compliance, enhancing corporate governance[149][150] - The company has confirmed the independence of all independent non-executive directors as of December 31, 2024[182] - The company has not proposed any service contracts with directors or supervisors that could be terminated without compensation within one year[176] - The company has not made any payments to third parties for obtaining director services as of December 31, 2024[179] Environmental and Social Responsibility - The company aims to minimize its environmental impact by reducing its carbon footprint and managing hazardous materials responsibly[156] - The company has a commitment to sustainable and environmentally friendly practices as part of its corporate social responsibility[156] - The board emphasizes compliance with environmental laws and regulations, with no significant adverse events reported during the reporting period[156] Shareholder Information - As of December 31, 2024, the total issued share capital of the company is 441,011,443 shares, including 441,010,235 H shares and 1,208 non-listed foreign shares[187] - Major shareholders include Mr. Zeng Min with 33,651,618 H shares, representing 7.63% of the total share capital[188] - The company has no related party transactions requiring independent shareholder approval or annual audit compliance[185] - The board has decided not to declare a final dividend for the year ending December 31, 2024[194]

金十期货4月29日讯，伦敦金属交易所（LME）有色金属库存及变化如下： 1. 铜库存202500吨，减少300吨。 2. 铝库存417575吨，减少2000吨。 3. 镍库存201564吨，增加138吨。 4. 锌库存177550吨，减少1775吨。 5. 铅库存267275吨，减少3750吨。 6. 锡库存2665吨，减少180吨。 LME有色金属库存日报 ...

智通财经APP讯，启明医疗-B(02500)发布截至2024年12月31日止年度业绩，该集团期内取得收益人民币 4.71亿元。 公告称，于报告期内，公司持续聚焦结构性心脏病领域，通过优化研发管线布局，进一步提升研发效 率，集中资源推进核心重点管线的临床进展。全球临床研发项目取得多项重要里程碑，展现公司强大的 全球临床研发及运营实力，国际化进程不断深化。公司自主研发首款自膨干瓣TAVR产品Venus- PowerX、首款球扩干瓣TAVR产品Venus-Vitae和肺动脉瓣膜产品VenusP-Valve相继开展临床试验，临床 进展稳步推进中;三尖瓣置换产品Cardiovalve欧洲关键性临床研究患者入组进展顺利，即刻术后效果优 异，展现出优秀的安全性和有效性，深受海外专家医生好评。这些产品未来有望为全球患者提供更加优 质的治疗方案。 截至本公告日期，公司已成功建立由十款创新器械组成的产品管线，涵盖心脏瓣膜疾病领域。心脏瓣膜 类疾病介入治疗是集团布局的核心治疗领域。公司产品包括已商业化四款TAVR产品–VenusA-Valve， VenusA-Plus，VenusA-Pro和VenusA-Deluxe，一款TPVR ...

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 470,833,000, a decrease of 4.2% compared to RMB 491,373,000 in 2023[3] - Gross profit for the same period was RMB 367,746,000, down 5.5% from RMB 389,205,000 in 2023[3] - The company reported a net loss of RMB 717,373,000 for the year, a slight improvement of 1.6% compared to a loss of RMB 729,056,000 in 2023[3] - Non-IFRS commercial profit increased significantly by 112.6% to RMB 97,670,000, with a commercial profit margin of 20.7% compared to 9.3% in the previous year[3] - The company reported an adjusted non-IFRS EBITDA loss of RMB 253,671,000, an improvement of 45.6% compared to a loss of RMB 465,959,000 in 2023[3] - Other income decreased to RMB 33,999 thousand in 2024 from RMB 57,427 thousand in 2023, a decline of 40.7%[27] - The group reported a pre-tax loss attributable to equity holders of RMB 714,307,000 in 2024, compared to a loss of RMB 703,754,000 in 2023, indicating a slight increase in losses[41] - The company recognized a full impairment loss of RMB 73.6 million on its investment in Opus, reflecting significant uncertainty regarding its ongoing viability[101] - The impairment loss on intangible assets was fully recognized at RMB 62.0 million, compared to RMB 15.8 million in 2023, reducing the carrying amount to zero[103] - The net impairment loss on financial assets increased to RMB 21.4 million, up from a reversal of RMB 2.2 million in 2023, primarily due to provisions for other receivables[106] Research and Development - Research and development expenses decreased to RMB 341,185,000 from RMB 524,915,000, reflecting a reduction of 35%[6] - The company invested RMB 341.2 million and RMB 524.9 million in R&D for the years ending December 31, 2024, and December 31, 2023, respectively[74] - Research and development costs for the year ended December 31, 2024, were RMB 341.2 million, a reduction of 35.0% from RMB 524.9 million in the previous year[95] - The company is focused on optimizing its R&D pipeline to enhance efficiency and accelerate clinical progress in core areas[49] - The company has established three R&D centers in Hangzhou, Israel, and California to enhance global collaboration and innovation efficiency[72] Market Expansion and Product Development - The company plans to focus on market expansion and new product development to drive future growth[2] - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases, including four commercialized TAVR products and several in clinical trials[52] - The company aims to continuously innovate and meet the growing demands of patients through the application of new technologies and materials[48] - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market reach[160] - The company plans to expand its market presence in the United States and Europe, targeting a 25% increase in market share by 2025[160] Financial Position and Liquidity - The company’s cash and cash equivalents decreased to RMB 298,036,000 from RMB 774,396,000, indicating a significant reduction in liquidity[10] - Total non-current assets decreased to RMB 2,447,290,000 from RMB 2,805,647,000, a decline of 12.7%[10] - Total current liabilities decreased significantly to RMB 361,749 thousand from RMB 805,168 thousand in 2023, a reduction of 55.1%[24] - The company reported a total asset net value of RMB 440,731 thousand, down from RMB 802,899 thousand in 2023, a decrease of 45%[24] - The total borrowings of the group as of December 31, 2024, were RMB 283.0 million, down from RMB 705.9 million as of December 31, 2023[120] - The capital debt ratio as of December 31, 2024, was 16.7%, a decrease from 28.3% as of December 31, 2023[120] - The net current assets of the group as of December 31, 2024, were RMB 440.7 million, a decrease of 45.1% from RMB 802.9 million as of December 31, 2023[121] Corporate Governance and Compliance - The company is committed to maintaining compliance with corporate governance codes and has adhered to all mandatory provisions during the reporting period[137] - The audit committee has reviewed the financial information for the year ending December 31, 2024, and discussed internal controls and financial reporting matters with the independent auditor[145] - The company has not engaged in the purchase, sale, or redemption of any of its listed securities during the year ending December 31, 2024[139] Employee and Operational Changes - As of December 31, 2024, the company has a total of 691 employees, down from 865 employees as of December 31, 2023[132] - The company is implementing cost reduction and efficiency enhancement measures to significantly reduce losses in its valve membrane business[136] Future Outlook - The company plans to focus on its core heart valve business and has begun to divest from the healthcare industry park project due to changes in the real estate market[104] - The group anticipates increased cash flow from operations due to the growth of existing commercial product sales and the launch of new products[119] - The company aims to achieve a 30% reduction in production costs through new manufacturing technologies by 2024[160]

消息面上，近日，由启明医疗自主研发的自膨胀式经导管肺动脉瓣膜产品VenusP-Valve在澳大利亚 墨尔本权威医院The Royal Melbourne Hospital成功开展澳大利亚首例商业应用。公司表示，VenusP- Valve在这重要的市场实现了首例商业化植入，标志着这款全球首个且唯一在中国和欧洲获批上市的自 膨胀式肺动脉瓣膜产品已正式推开澳洲市场的大门。 启明医疗-B大涨超22% VenusP-Valve在澳大利亚成 功开展首例商业化植入 启明医疗-B(02500)大涨超22%，截至发稿，涨22.4%，报2.24港元，成交额3184.42万港元。 据悉，启明医疗的瓣膜业务仍展现出强劲韧性。在国内市场，公司在心脏瓣膜行业维持龙头地位， 产品不断取得创新突破：全球首款应用于经导管主动脉瓣置换术(TAVR)的全释放全回收干瓣系统Venus- PowerX已于2024年12月在华西医院完成注册临床研究的全球首例入组，该确证性临床试验的启动标志 着其向临床转化迈出关键一步，有望在今年完成全部患者的临床入组，成为公司的下一个增长点。 ...

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 230.72 million, a decrease of 9.7% compared to RMB 255.61 million in the same period last year[9]. - Gross profit for the same period was RMB 181.76 million, reflecting a 9.7% decline from RMB 201.25 million year-on-year[9]. - Loss before tax was RMB 213.58 million, a 42.3% improvement from a loss of RMB 370.34 million in the previous year[9]. - Net loss for the period was RMB 208.83 million, down 43.0% from RMB 366.22 million year-on-year[9]. - Non-IFRS commercial profit increased by 85% to RMB 34.13 million from RMB 18.43 million in the previous year[9]. - The company's losses attributable to the listed company decreased by 41% year-over-year for the first half of 2024[11]. - The non-IFRS EBITDA decreased by 48.7% year-over-year for the same period[11]. - The EBITDA for the six months ended June 30, 2024, was RMB (145.3) million, an improvement from RMB (283.1) million for the same period in 2023[43]. - The company reported a net loss of RMB 208,825,000 for the six months ended June 30, 2024, compared to a net loss of RMB 366,215,000 in the prior year, indicating a 42.9% improvement[104]. - The company reported a total comprehensive loss of RMB 195,123,000, compared to a loss of RMB 310,069,000 for the same period in 2023, indicating an improvement of approximately 37%[109]. Clinical and Product Development - The company has made significant progress in clinical trials, including the successful implantation of the VenusP-Valve in the U.S. as part of a pivotal study[10]. - The Cardiovalve product has shown excellent safety and efficacy in key clinical studies in Europe, receiving positive feedback from international experts[10]. - The company aims to continue focusing on structural heart disease, optimizing its R&D pipeline to enhance efficiency and clinical progress[10]. - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases and hypertension[12]. - The VenusA series TAVR products have been commercialized in 13 countries and regions, with ongoing clinical trials for new generation TAVR products[13]. - VenusA-Valve, the first TAVR product approved in China, continues to demonstrate long-term safety and effectiveness in clinical follow-up studies[14]. - VenusP-Valve received CE MDR certification in April 2022 and NMPA approval in July 2022, marking it as the first self-expanding TPVR product approved in Europe and China respectively[15]. - The IDE (PROTEUS) pivotal clinical study for VenusP-Valve in the US is underway, with the first patient implanted in June 2024, aiming to enroll 60 participants[15]. - Venus-Vitae, the first balloon-expandable TAVR product, is entering the SMART-ALIGN global pivotal clinical trial phase, utilizing advanced anti-calcification technology for improved durability[16]. - Cardiovalve's clinical trial for mitral and tricuspid valve replacement is progressing, with nearly 100 patients enrolled in the TARGET CE pivotal trial across multiple countries[18]. Market Expansion and Revenue Generation - The number of TAVR implants reached approximately 2,300 units in the first half of the year, representing a 15% increase quarter-over-quarter[11]. - Overseas revenue from the Venus P-Valve product reached RMB 30.1 million, a year-over-year increase of 34%[11]. - The company expanded its commercial presence by entering 8 new countries, including Canada, Australia, India, Russia, and Singapore, bringing the total to 59 countries and regions[11]. - VenusA series products generated RMB 191.3 million in revenue, accounting for 82.9% of total revenue, while VenusP-Valve contributed RMB 38.3 million, representing 16.6%[28]. - Revenue from mainland China was RMB 200,620,000, down 13.9% from RMB 233,118,000 in the previous year[120]. - The revenue from other regions was RMB 30,100,000, an increase of 33.8% from RMB 22,492,000 in the previous year[120]. Financial Position and Assets - Total assets as of June 30, 2024, were RMB 3,402,412,000, down from RMB 3,608,546,000 as of December 31, 2023[106]. - Current assets decreased to RMB 1,095,145,000 from RMB 1,608,067,000, primarily due to a reduction in cash and cash equivalents[105]. - The company’s cash and cash equivalents were RMB 485,843,000, significantly lower than RMB 774,396,000 at the end of 2023[105]. - The total liabilities decreased to RMB 680,315,000 from RMB 689,200,000, reflecting a stable financial position[106]. - The company’s equity attributable to shareholders was RMB 2,725,525,000, down from RMB 2,920,648,000, indicating a decrease in shareholder value[106]. - The total interest-bearing bank borrowings decreased to RMB 395,571,000 as of June 30, 2024, down from RMB 705,907,000 at the end of 2023, representing a significant reduction of about 44%[134]. Governance and Compliance - The company has adopted and applied the principles and provisions of the corporate governance code, and has complied with the mandatory provisions during the reporting period[88]. - The board of directors currently consists of seven members, including three executive directors, two non-executive directors, and two independent non-executive directors, following the passing of an independent non-executive director[89]. - The company is in the process of identifying suitable candidates to fill the vacancy of independent non-executive director and related committee positions[89]. - The company is required to conduct a special audit and forensic investigation regarding unauthorized loans and other financial flows involving certain individuals and entities[94]. - The company has committed to timely disclosure of all significant information to shareholders and potential investors since the suspension of trading[98]. Employee and Shareholder Information - The total number of employees decreased to 778 as of June 30, 2024, from 1,006 as of June 30, 2023, with 652 based in China and 126 overseas[56]. - The total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 4,273,000, a decrease from RMB 4,450,000 in the same period of 2023[142]. - The major shareholders include Horizon Binjiang LLC with 33,651,618 H shares, representing 7.63% of the total shares[66]. - The company has a significant ownership structure with various stakeholders, including Dinova Healthcare Delta Fund and Shenzhen Dinova, holding substantial shares[71][72]. Research and Development - The company has established three R&D centers located in Hangzhou, Tel Aviv, and Irvine, California, to enhance its global innovation capabilities[21]. - The company is focused on utilizing the proceeds from its fundraising efforts for strategic initiatives and operational enhancements[75][76][77]. - The company is actively pursuing market expansion and new product development strategies, although specific details were not disclosed in the provided content[175]. - The company is focused on enhancing its product offerings, particularly in the medical device sector, to align with regulatory standards such as CE MDR certification[175]. Legal and Regulatory Matters - The company has initiated arbitration proceedings against Xin Nuo Tong Investment Limited regarding unauthorized loans that remain unpaid[96]. - There were no significant litigation or arbitration matters during the reporting period[88]. - The company is subject to the EU Medical Device Regulation (MDR) 2017/745, which impacts its product compliance and market strategy[176].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 230,720,000, a decrease of 9.7% compared to RMB 255,610,000 for the same period in 2023[2] - Gross profit for the same period was RMB 181,760,000, reflecting a 9.7% decline from RMB 201,249,000 year-over-year[2] - Loss before tax improved to RMB (213,581,000), a 42.3% reduction from RMB (370,339,000) in the prior year[2] - Net loss for the period was RMB (208,825,000), down 43.0% from RMB (366,215,000) in the previous year[2] - Non-IFRS commercial profit increased by 85% to RMB 34,131,000, compared to RMB 18,430,000 in the same period last year[2] - Non-IFRS EBITDA improved to RMB (145,286,000), a 48.7% reduction from RMB (283,098,000) year-over-year[2] - The basic and diluted loss per share attributable to ordinary shareholders was RMB (0.47), compared to RMB (0.80) in the same period last year, marking a 41.3% improvement[2] - The company's loss attributable to equity holders of the parent for the six months ended June 30, 2024, was RMB 206,487,000, compared to a loss of RMB 350,188,000 for the same period in 2023, representing a 41.0% improvement[22] Revenue Breakdown - Revenue from mainland China was RMB 200,620,000, down from RMB 233,118,000, reflecting a decline of 13.9%[13] - Revenue from other countries/regions increased to RMB 30,100,000, up 33.8% from RMB 22,492,000[13] - For the six months ended June 30, 2024, the company's revenue from medical equipment sales was RMB 230,720,000, a decrease of 9.7% compared to RMB 255,610,000 for the same period in 2023[13] - Revenue from VenusA series products accounted for 82.9% of total revenue, amounting to RMB 191.3 million, while VenusP-Valve contributed 16.6% with RMB 38.3 million for the six months ended June 30, 2024[52] Assets and Liabilities - Total assets as of June 30, 2024, were RMB 3,402,412,000, down from RMB 3,608,546,000 at the end of 2023[7] - Current liabilities decreased to RMB 494,350,000 from RMB 805,168,000 at the end of 2023[7] - Cash and cash equivalents were RMB 485,843,000, significantly lower than RMB 774,396,000 at the end of 2023[7] - The net current assets of the group as of June 30, 2024, were RMB 600.8 million, a decrease of 25.2% from RMB 802.9 million as of December 31, 2023[72] - The total borrowings of the group as of June 30, 2024, were RMB 395.6 million, down from RMB 705.9 million as of December 31, 2023, with a capital debt ratio of 18.3% compared to 28.3% previously[71] Operational Efficiency - The company is committed to improving operational efficiency and cost control, which is expected to enhance cash flow generation in the future[70] - The company aims to enhance operational efficiency and increase gross margin levels while controlling costs and optimizing resource allocation[84] - The company is focusing on cash flow management and may consider asset disposals and obtaining more bank credit to alleviate cash flow pressure[84] - The company has implemented new strategies to improve operational efficiency, aiming for a 10% reduction in production costs over the next year[92] Research and Development - The company invested RMB 180.8 million and RMB 294.7 million in R&D for the six months ending June 30, 2023, and 2024, respectively[43] - Research and development costs were RMB 180.8 million for the six months ended June 30, 2024, a reduction of 38.6% from RMB 294.7 million for the same period in 2023, primarily due to optimization of production line layout[57] - Research and development expenditures have increased by 15%, totaling RMB 300 million, to support innovation and new technology[92] - The company holds a total of 877 effective patents and patent applications, including 449 granted invention patents as of August 30, 2024[44] Market Expansion and Product Development - The company expanded its commercial presence by entering eight new countries, including Canada, Australia, and India, bringing the total to 59 countries and regions[30] - The company is actively pursuing market expansion strategies, targeting new regions in Europe and Asia to increase its market share[92] - New product development includes the launch of the Venus-PowerX Valve, which is currently in the research phase and expected to enhance the TAVR product line[93] - The company has completed a strategic acquisition of Cardiovalve Ltd., enhancing its product offerings in the aortic valve replacement market[92] Clinical Trials and Product Approvals - The company successfully completed the first patient implantation in the IDE pivotal clinical study for the VenusP-Valve product in the United States[29] - The IDE (PROTEUS) pivotal clinical study for VenusP-Valve in the U.S. is underway, with the first patient successfully implanted in June 2024, involving a total of 60 participants[36] - Venus-Vitae, the company's first balloon-expandable TAVR product, is set to enter the SMART-ALIGN global pivotal clinical trial phase, utilizing advanced anti-calcification technology[37] - The company has received CE MDR certification for its latest medical devices, ensuring compliance with European health and safety standards[91] Shareholder and Governance - The board of directors has proposed not to pay an interim dividend for the six months ending June 30, 2024, consistent with the previous year[85] - The company emphasizes the importance of protecting shareholder interests, particularly those of minority shareholders, amid ongoing challenges[84] - The audit committee has reviewed the interim financial results for the six months ending June 30, 2024, and found them to comply with relevant accounting standards[88] - The company is actively seeking suitable candidates to fill vacancies for independent non-executive directors to comply with listing rules[88]

Corporate Governance and Management Changes - The company appointed Lin Haosheng as the new General Manager effective November 20, 2023[4]. - The company has undergone significant changes in its board, with Hu Dingxu appointed as Chairman following the resignation of previous Chairman Zeng Min[4]. - The company has experienced changes in its board of directors, with several key resignations and appointments throughout 2023, including the resignation of the chairman and general manager[109][113]. - The board currently consists of seven directors, including three executive directors, two non-executive directors, and two independent non-executive directors, which does not meet the minimum requirements set by the listing rules[114]. - The company has established three board committees: the Audit Committee, the Remuneration and Assessment Committee, and the Nomination Committee[192]. - The company has a clear profit distribution plan and loss compensation strategy as part of its operational governance[184]. - The company has a structured approach to corporate governance, adhering to the corporate governance code and relevant regulations[194]. - The company is actively seeking suitable candidates to fill the vacancies of independent non-executive directors to comply with listing rules[114]. Financial Performance and Revenue Growth - Total revenue for the fiscal year ended December 31, 2023, reached RMB 491.37 million, an increase from RMB 406.46 million in 2022, representing a growth of approximately 20.9%[7]. - The company's total revenue for the year ended December 31, 2023, was RMB 491.4 million, an increase of 20.9% compared to RMB 406.5 million for the year ended December 31, 2022[32]. - Sales from the VenusA series products accounted for 83.4% of total revenue, while VenusP-Valve contributed 15.6% for the year ended December 31, 2023[33]. - The company's gross profit increased by 23.9% to RMB 389.2 million for the year ended December 31, 2023, compared to RMB 314.0 million for the previous year[35]. - The gross margin improved from 77.2% for the year ended December 31, 2022, to 79.2% for the year ended December 31, 2023, primarily due to economies of scale in production[35]. - Other income and gains for the year ended December 31, 2023, amounted to RMB 241.6 million, an increase of 63.2% compared to RMB 148.0 million for the year ended December 31, 2022, primarily due to fair value adjustments related to the acquisition agreement with Nuocheng[36]. Product Development and Market Expansion - The company is focusing on expanding its market presence and enhancing its product offerings[2]. - The company is committed to developing new technologies and products to strengthen its competitive position in the market[2]. - The company aims to deepen its international market expansion and enhance its commercialization pipeline through innovative product development[10]. - The company has established a product pipeline consisting of 12 innovative devices targeting heart valve diseases, hypertrophic cardiomyopathy, and hypertension[11]. - VenusP-Valve has entered over 50 countries and regions, including Germany, France, the UK, Italy, Spain, Australia, and Canada, with ongoing international expansion efforts[6]. - The company is actively pursuing strategic initiatives, including potential mergers and acquisitions, to drive growth[2]. - The company is focusing on expanding its product pipeline and enhancing its market position with innovative technologies and clinical trials[14][15][17][18]. Clinical Trials and Research - The company is advancing the Cardiovalve Target CE clinical trial for tricuspid valve replacement, with over 70 patients enrolled across more than 20 renowned centers in Europe and North America[6]. - The Venus-Vitae and Venus-PowerX products are in the critical clinical trial phase, with early feasibility studies completed in Argentina and Chile[12]. - The Liwen RF system for treating hypertrophic cardiomyopathy has completed patient enrollment for critical clinical studies[12]. - Cardiovalve's clinical trial for TMVR/TTVR products is progressing rapidly, with over 70 patients enrolled in the TARGET CE pivotal trial across more than 20 medical centers in the UK, Germany, Italy, and Canada[20]. - The Liwen RF radiofrequency ablation system achieved a treatment success rate of 86.1% (68/79) in a follow-up of 79 patients six months post-surgery, significantly improving key clinical endpoints[21]. Financial Challenges and Losses - The company reported a pre-tax loss of RMB 735.34 million for 2023, an improvement from a loss of RMB 1,156.34 million in 2022[7]. - The basic and diluted loss per share for 2023 was RMB 1.61, compared to RMB 2.42 in 2022, reflecting a reduction in losses[7]. - The company has faced cumulative losses since its establishment and anticipates potential future losses due to the high-risk nature of the medical device industry[71]. - Future growth is heavily dependent on the successful development and commercialization of its pipeline products, with significant risks associated with clinical trials and regulatory approvals[71]. Regulatory Compliance and Risk Management - The company is required to conduct a special audit and forensic investigation regarding loans provided to certain individuals and disclose the findings[62]. - Regulatory compliance is critical, as delays in obtaining necessary approvals could severely impact the commercialization of pipeline products[73]. - The company recognizes that risk management is crucial for business success, facing operational risks related to the medical device market and regulatory changes in China and globally[81]. - The audit committee oversees the overall risk management related to business operations, including reviewing and approving risk management policies and monitoring significant risks[82]. - The company has adopted a comprehensive risk management policy to identify, assess, and monitor key risks related to strategic objectives on a continuous basis[83]. Shareholder and Ownership Structure - As of December 31, 2023, the total issued share capital of the company is 441,011,443 shares, consisting of 441,010,235 H shares and 1,208 non-listed foreign shares[134]. - Major shareholder Mr. Zeng holds 33,651,618 H shares, representing 7.63% of the total issued share capital[136]. - The company has a diverse shareholder base, with multiple entities holding significant stakes, including Qiming Venture Partners III, L.P. with 40,018,283 H shares, or 9.07%[137]. - The total percentage of H shares held by major shareholders indicates a concentrated ownership structure, with the top three shareholders holding over 27% of the total shares[136][137]. Corporate Social Responsibility and Environmental Compliance - The company emphasizes sustainable and environmentally friendly practices, aiming to minimize its carbon footprint[103]. - The company has complied with all relevant environmental laws and regulations during the reporting period[103]. - The group reported charitable donations amounting to RMB 42.8 million during the reporting period, a decrease from RMB 70.3 million in the previous year[149]. Marketing and Sales Strategies - The company utilizes a strategic marketing model to promote its products through partnerships with hospitals and leveraging its opinion leader network for academic marketing in China[105]. - The company actively participates in significant cardiology conferences in China, showcasing product innovations and providing training on TAVR and TPVR procedures[106]. - The marketing efforts primarily target large tertiary hospitals, which have more resources for interventional cardiac valve procedures compared to smaller hospitals[106]. - The company relies on opinion leaders to introduce and recommend its products to physicians and hospitals, enhancing clinical benefits through academic incentives[106].