ocienlech Stock Code 股份代號 : 2291 | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------------------------------|-------|-------|-------|-------|-------|-------|-------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | * For identification purposes only * 僅供識別 | | | | | | | Interim Report 中期報告 | | 2024 | Contents 目錄 | --- | --- | --- | --- | |----------------- ...

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之內容概不負責，對其準確性 或完整性亦不發表任何聲明並明確表示，概不對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。 LEPU SCIENTECH MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.* 樂普心泰醫療科技（上海）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：2291） 截至2024年6月30日止六個月的中期業績公告 董事會欣然宣佈本集團截至2024年6月30日止六個月的未經審計綜合財務業績， 連同截至2023年6月30日止六個月的比較數字如下。 本集團截至2024年6月30日止六個月的中期業績已由審計委員會及本公司獨立核 數師立信會計師事務所（特殊普通合夥）根據中國註冊會計師協會頒佈的中國註冊 會計師審閱準則第2101號「由實體的獨立核數師執行中期財務資料審閱」審閱。 財務摘要 － 收入由截至2023年6月30日止六個月的人民幣166.4百萬元增長49.7%至截至 2024年6月30日止六個月的人民幣249.1百萬元。 － 毛利由截至2023年6月30日止 ...

Stock Code 股份代號: 2291 ...

智通财经APP讯，心泰医疗(02291)公布2023年业绩，收入约3.26亿元，同比增加31.6%。研发费用同比 增加14.3%至6160万元，公司拥有人应占利润1.515亿元，同比扭亏为盈。经调整纯利同比增加55.4%至 1.73亿元，每股盈利0.44元，末期股息每股0.57元(含税)。 截至本公告日期，该集团共计拥有22款已上市封堵器及配件产品，9款注册审评及注册准备中产品，另 有24款处于不同研发阶段的封堵器、心脏瓣膜及手术配件、机械循环辅助等在研产品。 ...

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依 賴該等內容而引致的任何損失承擔任何責任。 LEPU SCIENTECH MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.* 樂普心泰醫療科技（上海）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：2291） 截至2023年12月31日止年度的年度業績公告 董事會欣然宣佈本集團截至2023年12月31日止年度的經審計綜合年度業績，連同 截至2022年12月31日止年度的比較數字如下。 財務摘要 － 收入由截至2022年12月31日止年度的人民幣247.7百萬元增加31.6%至截至 2023年12月31日止年度的人民幣325.9百萬元。 － 毛利由截至2022年12月31日止年度的人民幣219.7百萬元增加31.5%至截至 2023年12月31日止年度的人民幣288.8百萬元。 － 研發費用由截至2022年12月31日止年度的人民幣53.9百萬元增加14.3%至截 至2023年12月31日止年度的 ...

智通财经APP讯，心泰医疗(02291)发布公告，集团预期截至2023年12月31日止年度将取得公司拥有人应 占纯利约人民币1.4亿元至约人民币1.6亿元，而截至2022年12月31日止年度则取得公司拥有人应占亏损 人民币1980万元。估计非国际财务报告准则利润约人民币1.6亿元至约人民币1.8亿元，而截至2022年12 月31日止年度则约为人民币1.11亿元。 公告称，股东应占纯利之预期增加主要是由于以下原因： (1) 集团之新一代镍钛合金封堵器产品于报告 期内的销量较截至2022年12月31 日止年度大幅增加。此增长乃受集团前瞻性研发策略思维、强大营销 能力、有效学术推广及广泛经销商网络所推动，从而令该等产品之市场销量进一步提高;及 (2) 鉴于集团 一直贯彻的研发创新策略，(i)于2022年2月取得中国国家药品监督管理局药品审评中心注册证书的 MemoSorb®全降解封堵器系统及 (ii)于2023年9月获得CDE注册证书的MemoSorb®生物可降解卵圆孔未 闭封堵器，上述两款产品作为集团之创新产品，于报告期内取得了较截至2022年12月31日止年度而言更 好的销售业绩。 公司相信，集团会维持和扩大其 ...

cienlech Stock Code 股份代號 : 2291 * For identification purposes only * 僅供識別 Interim Report2023 中期報告 Contents 目錄 | --- | --- | --- | --- | |---------------------------------------|-------|--------------------------|-------| | Definitions 2 | | 釋義 2 | | | Corporate Information 7 | | 公司資料 7 | | | Financial Highlights 10 | | 財務摘要 10 | | | Management Discussion and Analysis 11 | | 管理層討論與分析 11 | | | Other Information 39 | | 其他資料 39 | | | Report on Review of 46 | | 中期財務資料的審閱報告 | 46 | | Interim Financial Information ...

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依 賴該等內容而引致的任何損失承擔任何責任。 LEPU SCIENTECH MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.* 樂普心泰醫療科技（上海）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：2291） 截至2023年6月30日止六個月的中期業績公告 董事會欣然宣佈本集團截至2023年6月30日止六個月的未經審計綜合財務業績， 連同截至2022年6月30日止六個月的比較數字如下。 財務摘要 － 收入由截至2022年6月30日止六個月的人民幣124.8百萬元增長33.0%至截至 2023年6月30日止六個月的人民幣165.9百萬元。 － 毛利由截至2022年6月30日止六個月的人民幣109.5百萬元增長34.8%至截至 2023年6月30日止六個月的人民幣147.5百萬元。 － 研發費用由截至2022年6月30日止六個月的人民幣19.6百萬元增長36.5%至截 至2023年6月30日止六個月 ...

Company Overview and Listing Information - The company's stock code is 2291 and it is listed on the Main Board of the Stock Exchange[11] - Lepu ScienTech Medical Technology (Shanghai) Co., Ltd. was listed on the Main Board of the Stock Exchange on November 8, 2022[23] - The company is registered as a non-Hong Kong company under the Companies Ordinance (Chapter 622 of the Laws of Hong Kong)[28] - The company's legal address in the PRC is Room 201, Building 41, No. 258, Xinzhuan Road, Songjiang District, Shanghai[31] - The company's head office in the PRC is located at 1/F and 5/F, Building 41, No. 258, Xinzhuan Road, Songjiang District, Shanghai[31] - The principal place of business in Hong Kong is 31/F, Tower Two Times Square, 1 Matheson Street, Causeway Bay, Hong Kong[31] - The company's auditor is PricewaterhouseCoopers, Certified Public Accountants and Registered Public Interest Entity Auditor[31] Financial Performance and Statements - The company's 2022 Annual Report includes financial highlights, management discussion and analysis, and a corporate governance report[2][3] - The company's financial statements are prepared in accordance with International Financial Reporting Standards (IFRS)[18] - The company's financial statements include a consolidated statement of profit or loss, consolidated balance sheet, and consolidated statement of cash flows[3] - Revenue increased by 11.3% from RMB222.6 million in 2021 to RMB247.7 million in 2022[34] - Gross profit increased by 11.2% from RMB197.5 million in 2021 to RMB219.7 million in 2022[34] - Research and development expenses increased by 30.2% from RMB41.4 million in 2021 to RMB53.9 million in 2022[34] - Net other income and gains decreased from RMB22.6 million in 2021 to a net loss of RMB69.5 million in 2022[34] - Profit attributable to owners of the Company decreased from RMB58.7 million in 2021 to a loss of RMB19.8 million in 2022[34] - Non-IFRS Adjusted Net Profit increased by 1.5% from RMB109.5 million in 2021 to RMB111.1 million in 2022[34] - Net cash flow from operating activities decreased by 37.8% to RMB65.5 million in 2022[36] - Total assets increased by 61.6% to RMB1,809.6 million as of December 31, 2022[36] - Net assets increased by 352.9% to RMB1,744.5 million as of December 31, 2022[36] - Revenue for the year ended December 31, 2022, was RMB247.7 million, representing a year-on-year increase of 11.3%[59] - Loss attributable to owners of the company for the year ended December 31, 2022, was RMB19.8 million, a year-on-year decrease of 133.7%[59] - Non-IFRS Adjusted Net Profit for the year ended December 31, 2022, was RMB111.1 million, a year-on-year increase of 1.5%[59] - Net cash flow generated from operating activities for the year ended December 31, 2022, was RMB65.5 million, a year-on-year decrease of 37.8%[59] - Total assets as of December 31, 2022, were RMB1,809.6 million, an increase of 61.6% from the beginning of the year[59] - Net assets as of December 31, 2022, were RMB1,744.5 million, an increase of 352.9% from the beginning of the year[59] - The company reported a net loss of RMB19.8 million for 2022, compared to a net profit of RMB58.7 million in 2021[116] - Cash and cash equivalents increased by 32.4% from RMB713.5 million in 2021 to RMB944.5 million in 2022, primarily due to proceeds from the Global Offering and operational activities[117] - Net cash generated from operating activities decreased by RMB39.7 million to RMB65.5 million in 2022, attributed to extended payment collection periods and increased inventories and prepayments[119][120] - Net cash used in investing activities increased by RMB320.8 million to RMB406.0 million in 2022, mainly due to investments in wealth management products and long-term bank deposits[120] - Net cash generated from financing activities in 2022 was RMB577.8 million, a decrease of RMB94.4 million from RMB672.2 million in 2021[121] - Global Offering proceeds received in November 2022 amounted to RMB601.6 million, partially offset by share issuance costs of RMB21.9 million[121] - Net current assets increased to RMB1,265.9 million in 2022 from RMB62.5 million in 2021, driven by Global Offering proceeds and reclassification of redemption liabilities[124] - Redemption liabilities of approximately RMB775.0 million were derecognized upon completion of the Global Offering, with a difference of RMB103.5 million credited to other reserves[131] - Total capital expenditure for 2022 was approximately RMB83.4 million, compared to RMB91.8 million in 2021, primarily for property, plant, equipment, and R&D expenses[127] - Capital commitments as of December 31, 2022, were RMB1.3 million, primarily for property, plant, and equipment purchases[127] - Total staff costs for 2022 amounted to approximately RMB86.0 million, covering remuneration, bonuses, welfare, and social insurance fees[129] - The company had 236 full-time employees as of December 31, 2022, all based in China[129] - No outstanding borrowings or unutilized banking facilities as of December 31, 2022[123] - No material acquisitions, disposals, or significant investments during 2022[125] - Redemption liabilities decreased significantly from RMB 679,986 thousand in 2021 to RMB 0 in 2022 due to derecognition after the completion of the global offering[135][136] - The company's gross profit margin remained stable at 88.7% in 2022 compared to 88.8% in 2021[139] - Net profit margin dropped sharply from 26.4% in 2021 to -8.0% in 2022, primarily due to decreased net profit[139] - Current ratio increased dramatically from 1.1 in 2021 to 20.9 in 2022, driven by increased current assets and decreased current liabilities[139][141] - Non-IFRS adjusted net profit showed minimal growth, increasing from RMB 109,494 thousand in 2021 to RMB 111,089 thousand in 2022[143] - Listing expenses, net of tax, decreased from RMB 24,518 thousand in 2021 to RMB 15,329 thousand in 2022[143] - Net foreign exchange losses from retranslation of USD-denominated redemption liabilities were RMB 76,377 thousand in 2022, compared to gains of RMB 2,837 thousand in 2021[143] - Interest expense on redemption liabilities increased from RMB 11,316 thousand in 2021 to RMB 18,683 thousand in 2022[143] - Share-based payment expenses rose from RMB 17,800 thousand in 2021 to RMB 20,513 thousand in 2022[143] - The company had no borrowings as of December 31, 2021 and 2022, resulting in no gearing ratio being presented[139] Corporate Governance and Shareholders - The company's controlling shareholder is Lepu Medical, and the actual controller is Dr. Pu Zhongjie[11] - The company's corporate governance practices are in line with the Corporate Governance Code as set out in Appendix 14 to the Listing Rules[8] - The company's 2022 AGM is scheduled to be held on June 15, 2023[6] - The company's Pre-IPO investors include CDH Supermatrix D Limited and Huaihua Haozhi Enterprise Management Partnership[7][17] - The Pre-IPO Shareholders Agreement was signed on May 28, 2021, involving Lepu Medical, Dr. Pu, and other stakeholders[25] - The Prospectus for the Hong Kong public offering of shares was issued on October 27, 2022[25] - Net proceeds from the Global Offering amounted to approximately HK$567.3 million after deducting underwriting commissions and related expenses[183] - The company intends to fully utilize the net proceeds raised from the Global Offering by December 31, 2027, subject to changes in business needs and market conditions[184] - The company has not utilized any of the net proceeds raised from the Global Offering, except for a subscription of a wealth management product for treasury management purposes, which was fully redeemed by the date of the Annual Report[183] - The company raised a net amount of approximately HKD 567.3 million from its global offering, which was listed on the Hong Kong Stock Exchange on November 8, 2022[186] - The company plans to utilize the net proceeds from the global offering within the five fiscal years from 2023 to 2027, with full utilization expected by December 31, 2027, subject to changes due to evolving business needs and market conditions[186] Products and R&D - The company's products include the TAVR system, TMVCRS, and balloon dilatation catheter for aortic valve, which are developed, registered, and produced by the Retained Lepu Medical Group[10] - The company successfully launched the MemoSorb® fully biodegradable occluder system, the world's first commercially available product of its kind[35] - The company's third-generation CHD occluders, MemoCarna® oxide coating single-rivet occluder products, continued to increase in volume in 2022, becoming a backbone of the CHD occluder product segment[39][40] - The fourth-generation MemoSorb® fully biodegradable occluder system, approved in early 2022, has been successfully clinically applied in multiple hospital centers across regions including Beijing, Henan, Shaanxi, Anhui, Hubei, Sichuan, Guangdong, and Guangxi[39][40] - The MemoSorb® biodegradable ASD occluder product candidate completed its clinical trial stage, with registration application submission to the NMPA expected in Q2 2023 and approval anticipated in Q2 2024[39][40] - The MemoSorb® biodegradable PFO occluders entered the NMPA review stage in 2022 and are expected to be approved for marketing by the end of 2023[39][40] - The BioLefort® biodegradable LAA occluders have entered the clinical trial stage and completed the world's first clinical enrollment of FIM[39][40] - The company has a total of 18 marketed occluders and accessory products, 10 products under registration review and preparation, and 27 product candidates in various stages of R&D as of March 31, 2023[44] - The GuiBend® interventional delivery system II (Integrated) submitted the CE certification application in 2022, and the third-generation MemoCarna® oxide coating single-rivet occluder series products are preparing to submit CE certification applications[41][42] - The company is actively planning overseas clinical trials for biodegradable occluder series products to accelerate the commercialization process in overseas markets[41][42] - The company has established various technical platforms related to valve products, leveraging years of basic research, and is expected to become a leading enterprise in the valve products field[39][40] - The company aims to strengthen its technological leadership and market dominance in the structural heart diseases field through a series of innovative products launched and to be launched in the next three to five years[41][42] - MemoPart® ASD occluder (Double-rivet) and MemoPart® ASD occluder (Single-rivet) have been commercialized[47] - MemoCarna® Oxide coating ASD occluder with double-rivet is in preparation for CE registration materials[47] - MemoSorb® Biodegradable ASD occluder is in preparation for NMPA registration materials[47] - MemoPart® VSD Occluder (Double-rivet) and MemoPart® VSD Occluder (Single-rivet) have been commercialized[47] - MemoCarna® Oxide coating VSD occluder with single-rivet is in preparation for CE registration materials[47] - MemoSorb® full-degradable occluder systems are in preparation for initial overseas clinical trials[47] - MemoPart® PDA occluder (Double-rivet) and MemoPart® PDA occluder (Single-rivet) have been commercialized[49] - MemoCarna® Oxide coating PDA occluder is in preparation for CE registration materials[49] - MemoSorb® Biodegradable PFO occluder is undergoing supplementary materials submission for NMPA registration[49] - MemoLefort® LAA closure occluder systems have been commercialized[49] - The company has 16 commercially available CHD occluder products, with MemoCarna® III and MemoSorb® IV being key products[60] - The MemoSorb® biodegradable ASD occluder is expected to receive NMPA approval and be available for sale in the second quarter of 2024[60] - The MemoSorb® biodegradable PFO occluder is in the registration process and is expected to be approved by the NMPA within 2023[60] - The Bio-Lefort® biodegradable LAA occluder has entered the stage of multi-center clinical trial enrollment[60] - The company has six commercially available occluder-related procedural accessories, with the Snare II product expected to obtain a registration certificate and list for sale in the second half of 2023[62] - The company has built out 16 heart valve product candidates, with the TAVR system completing clinical trial enrollment in September 2022 and most patients completing six-month follow-ups with satisfactory results[62] - The ScienCrown® valve, with distinct structural advantages, is planned for a registration application to the NMPA by the end of 2023[62] - The transapical mitral valve clip system is in the final stage of clinical trial enrollment with satisfactory follow-up results[62] - The company has expanded into the mechanical circulatory support (MCS) devices field, with products in various stages of development, including the transcatheter left ventricular support system in preclinical type inspection preparation[63][64] - The company owns six types of valve-related procedural accessories, including a vascular closure device system with innovative design structure currently in preparation for inspection[65][66] - The company plans to continue developing new technologies and products targeting structural heart diseases, focusing on material innovation, structural design innovation, and production process optimization[69] - The company will leverage its market advantages in the CHD interventional devices field to increase the speed of iteration of innovative products and drive rapid business growth[70] - The company will promote the research and development of biodegradable occluder product candidates, including PFO and LAA occluders, to capitalize on growth potential in low penetration rate markets[70] - The company will focus on developing new technologies for structural heart disease, including material innovation, structural design innovation, and production process optimization, to enhance product innovation, functionality, and reliability[71] - The company is accelerating the R&D of the transfemoral mitral valve clip repair (TMVr-F) and the transcatheter mitral valve replacement system (TMVR) to achieve full coverage of mitral valve disease treatment[72] - The global market scale of MCS devices is expected to reach USD 3.4 billion in 2025, with a compound annual growth rate of 10.4% from 2021 to 2028[73] - The company is developing a surgically implantable sutureless heart valve and a transcatheter implantable aortic valve system for patients with simple aortic regurgitation, complementing the ScienCrown® transcatheter aortic valve replacement system[72] - The company has completed in-vitro durability tests for its artificial heart valve with polymer leaflets for more than 100 million times, showing promising results[72] - The market size of vascular closure devices in China is expected to increase from RMB 500 million in 2019 to RMB 4.5 billion in 2023, with a compound annual growth rate of 22.0%[75] - The company's radiofrequency atrial septal puncture system is in a leading position in China, with a potential treatment population of over 10 million[77] Subsidiaries and Investments - The company's subsidiary, Anhui Magete Medical Technology Co., Ltd., was established on November 22, 2016[6] - Lepu India, a wholly-owned subsidiary of Lepu Medical, was incorporated on April 30, 2016, in India[22] - Lepu Shanghai, a non-wholly owned subsidiary of Lepu Medical, was established on March 1, 2016, in China[23] - Ningbo Bingkun, a non-wholly owned subsidiary of Lepu Medical, was established on November 24, 2014, in China[23] - Ningbo Jiacheng, a shareholding platform for Lepu Medical Group employees, was established on February 22, 2021, in China[23] - Ningbo Jiadu, a shareholding platform for Lepu ScienTech employees, was established on February 22, 2021, in China[25] - Shanghai Shape Memory Alloy Co., Ltd. is a wholly-owned subsidiary established on May 5, 1994[26] - Sequoia Capital China Growth is a Pre-IPO investor incorporated under the laws of the Cayman Islands on April 12, 2021[26] Revenue Breakdown - Revenue increased from RMB222.6 million in 2021 to RMB247.7 million in 2022, representing an 11.3% growth[83][84] - CHD occluder products revenue grew from RMB132.5 million in 2021 to RMB182.7 million in 2022, accounting for 73.8% of total revenue[85][87] - ASD occluder products revenue increased from RMB99.8 million in 2021 to RMB136.2 million in 2022, representing 55.0% of total revenue[85][88] - VSD occluder products revenue rose from RMB19.8 million in 2021 to RMB28.5 million in 2022, accounting for 11.5% of total revenue[85][88] - PDA occluder products revenue increased from RMB12.9 million in 2021 to RMB

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依 賴該等內容而引致的任何損失承擔任何責任。 LEPU SCIENTECH MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.* 樂普心泰醫療科技(上海）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：2291） 截至2022年12月31日止年度的年度業績公告 董事會欣然宣佈本集團截至2022年12月31日止年度的經審計綜合年度業績，連同 截至2021年12月31日止年度的比較數字如下： 財務摘要 － 收入由截至2021年12月31日止年度的人民幣222.6百萬元增加11.3%至截至 2022年12月31日止年度的人民幣247.7百萬元。 － 毛利由截至2021年12月31日止年度的人民幣197.5百萬元增加11.2%至截至 2022年12月31日止年度的人民幣219.7百萬元。 － 研發開支由截至2021年12月31日止年度的人民幣41.4百萬元增加30.2%至截 至2022年12月31日止年度的 ...