Financial Performance - Total revenue for the year ended December 31, 2023, reached approximately RMB 473.8 million, a year-on-year increase of 19.8%[23] - Gross profit for the same period was approximately RMB 377.4 million, reflecting a year-on-year growth of 12.2%[23] - The company reported a significant decrease in profit before tax, down 79.4% to RMB 14.5 million from RMB 70.3 million in the previous year[23] - Adjusted net profit for the year was RMB 42.4 million, representing a year-on-year increase of 22.1%[23] - The company's revenue for the year ended December 31, 2023, was approximately RMB 473.8 million, an increase of about 19.8% compared to RMB 395.5 million for the year ended December 31, 2022[58] - Sales of core products, particularly AcoArt Tulip® and Litos®, contributed significantly to revenue growth, with core product sales reaching RMB 323.5 million, accounting for 68.3% of total revenue[59] - Revenue from venous intervention, vascular access, and other products increased by approximately 70.3%, rising from 22.3% of total revenue in 2022 to 31.7% in 2023[58] Product Development and Innovation - The company launched four new products in 2023, including the RT-Zero® coronary CTO balloon and AcoStream® second-generation peripheral thrombectomy system[27] - AcoArt Litos®, the world's first clinically validated below-the-knee drug-coated balloon, received FDA investigational device exemption (IDE) approval for clinical studies in the U.S.[27] - The company registered 19 new patents and submitted 26 new patent applications during the reporting period[30] - The company’s product pipeline includes over 30 products across various medical fields, with significant advancements in research and clinical trials in 2023[32] - The company received FDA IDE approval for clinical research of the BTK DCB in the United States, marking a significant milestone in its product development[32] - The company is advancing production development at a rapid pace, with significant progress in its product pipeline[35] - The company plans to commercialize 15 products by 2026, with several receiving regulatory approvals, including CE and NMPA certifications[35] Regulatory Approvals and Market Expansion - Four products received approval from the National Medical Products Administration during the reporting period, including two upgraded versions: AcoStream® II and ACOART AVENS®[34] - The coronary CTO recanalization balloon (RT-Zero®) and the coronary CTO antegrade microcatheter (Vericor-14®) further expand the company's product portfolio in the cardiology field[34] - The company is expanding the indications for AcoArt Orchid® & Dhalia® to include treatment for vertebral artery atherosclerotic stenosis, with expected regulatory approval in 2024[38] - The company anticipates obtaining regulatory approval for the peripheral scoring balloon in 2024, having submitted the product registration in 2023[45] - The company expects to obtain regulatory approval for the coronary rapamycin DCB in 2024, following the completion of clinical trials[47] Strategic Partnerships and Collaborations - The company established a strategic partnership with Boston Scientific, outlining collaboration in product commercialization, manufacturing services, and product development over the next three years[31] - A framework agreement was signed with BSG on July 20, 2023, to regulate ongoing related party transactions and facilitate global market sales of the company's products[56] - The cooperation agreement allows BSG to sell its products through the company in the Greater China region, and vice versa[128] Research and Development - The company has a strong internal R&D team with 66 registered patents and 30 pending applications as of December 31, 2023[51] - Research and development costs for the year ended December 31, 2023, were approximately RMB 1,901 million, a 3.4% increase from RMB 1,838 million for the year ended December 31, 2022, mainly due to an increase in the number of R&D personnel[63] - The company aims to enhance its R&D capabilities through increased investment in technological innovation to maintain its leading position in the DCB market[57] Financial Position and Liabilities - Non-current assets increased by 159.5% to RMB 399.9 million as of December 31, 2023, compared to RMB 154.1 million in 2022[25] - Total assets grew by 14.2% to RMB 1,611.1 million in 2023, up from RMB 1,410.5 million in 2022[25] - Total liabilities increased by 133.9% to RMB 314.5 million in 2023, compared to RMB 134.5 million in 2022[25] - The company's capital debt ratio increased from approximately 10.5% as of December 31, 2022, to approximately 24.3% as of December 31, 2023, mainly due to an increase in lease liabilities[72] Corporate Governance and Management - The board of directors consists of seven members, including two executive directors and three independent non-executive directors, ensuring a balanced governance structure[186] - The company has established three committees: audit committee, remuneration committee, and nomination committee, each with defined responsibilities[197] - The audit committee confirmed that the annual performance for the year ending December 31, 2022, complied with relevant accounting standards and regulations[199] Market Strategy and Sales - The company employs a strategic marketing model, leveraging relationships with hospitals and a KOL network to promote products in China[53] - The company is focusing on expanding its core products across three therapeutic areas, indicating a strategic approach to market growth[36] - The company aims to diversify its revenue sources through accelerated international business development, enhancing its ability to respond to market changes[78] Employee and Workforce Development - As of December 31, 2023, the company employed a total of 638 staff, with the R&D team growing to 127 members, enhancing its talent pool[33] - The company has implemented various internal occupational health and safety procedures to maintain a safe working environment[103] Shareholder and Equity Information - The total reserves available for distribution to equity shareholders as of December 31, 2023, amounted to RMB 1,341,822,000, a decrease from RMB 1,357,317,000 in 2022[107] - The company has confirmed the independence of all independent non-executive directors as of the report date[114] - The board does not recommend the distribution of a final dividend for the year ending December 31, 2023[80] Environmental and Social Responsibility - The company emphasizes its commitment to sustainable development and environmental responsibility in its operations[101] - The total amount of donations made by the group for the year ended December 31, 2023, was approximately RMB 1.83 million[177]

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 473.8 million, representing a year-on-year increase of 19.8% from RMB 395.5 million in 2022[2] - Gross profit for the same period was RMB 377.4 million, up 12.2% from RMB 336.4 million in the previous year[2] - Adjusted net profit for the year was RMB 42.4 million, an increase of 22.1% compared to RMB 34.8 million in 2022[2] - Operating profit decreased significantly to RMB 25,009 thousand from RMB 72,075 thousand, a decline of 65.3%[6] - Net profit for the year was RMB 14,487 thousand, down 79.3% from RMB 70,142 thousand in 2022[7] - Basic and diluted earnings per share were both RMB 0.05, compared to RMB 0.23 in the previous year, reflecting a decrease of 78.3%[6] - Total comprehensive income for the year was RMB 15,179 thousand, a decrease of 78.4% from RMB 70,204 thousand in 2022[8] - Revenue from new products, including the second-generation peripheral suction system and radiofrequency ablation systems, contributed approximately RMB 150.3 million, accounting for about 31.7% of total revenue[4] - Core product revenue reached RMB 323,536 thousand in 2023, up from RMB 307,283 thousand in 2022, representing a growth of 5.1%[16] - Revenue from vascular intervention, access products, and others increased significantly to RMB 150,312 thousand in 2023 from RMB 88,262 thousand in 2022, marking a growth of 70.5%[16] Product Development and Approvals - The company registered 19 new patents and submitted 26 new patent applications during 2023[3] - A total of four new products received approval from the National Medical Products Administration in 2023, including upgrades to existing products[4] - The company received FDA IDE approval for BTK DCB clinical research, marking a significant advancement in its product pipeline[48] - AcoArt Daisy® clinical trial showed a target vessel restenosis rate of 6.85%, significantly lower than the stent group, indicating strong clinical efficacy[48] - AcoArt Orchid® & Dhalia® received the latest registration certificate for the expanded indication for treating AVF stenosis from the National Medical Products Administration in July 2022[56] - The company has received regulatory approval for the AV scoring balloon (Peridge®) on January 30, 2024[54] - The second-generation peripheral suction system (AcoStream® II) received approval from the National Medical Products Administration in April 2023[6] - The PTA balloon (P-Conic®) was approved by the National Medical Products Administration in December 2022, with no significant adverse changes reported since then[6] - The coronary CTO recanalization balloon (RT-Zero®) received approval in March 2023, with no significant adverse changes reported since then[66] - The company has submitted product registration for the peripheral scoring balloon in 2023, expecting approval in 2024[6] Market Expansion and Collaborations - The company expanded its international business, achieving market approvals in Japan and Thailand, bringing its product commercialization to a total of 15 countries[5] - The company signed a comprehensive cooperation agreement with Boston Scientific Group plc, enhancing collaboration in product commercialization and development over the next three years[5] - The company has established distribution agreements for its peripheral DCB products in the European market and various coronary products in the Chinese market, enabling BSC to begin sales in the domestic market[78] - A framework agreement was signed with BSG on July 20, 2023, to facilitate global market sales of the company's products, promoting revenue diversification[79] - The company plans to continue expanding its product pipeline and market presence through internal development, mergers, and acquisitions, supported by various financing channels including internal funds and bank loans[102] Research and Development - The total number of employees reached 638, with the R&D team growing to 127 members, enhancing the company's talent pool[5] - R&D expenses amounted to RMB 190,070 thousand in 2023, slightly increasing from RMB 183,796 thousand in 2022, a growth of 3.5%[24] - The company is focused on the research and development of vascular disease treatment solutions, indicating ongoing investment in innovation and market expansion[12] - The company aims to enhance its R&D capabilities by increasing investment in technological innovation to strengthen its competitive position in the DCB market[79] - The company is committed to enhancing its product offerings in response to market needs[54] Financial Position and Assets - Current assets totaled RMB 1,094,879 thousand, while total assets less current liabilities amounted to RMB 1,494,812 thousand, an increase from RMB 1,311,870 thousand in 2022[10] - Non-current liabilities increased to RMB 198,284 thousand from RMB 35,781 thousand, primarily due to lease liabilities[11] - The company's equity attributable to shareholders rose slightly to RMB 1,296,528 thousand from RMB 1,276,089 thousand in 2022[11] - The group had cash and cash equivalents of approximately RMB 879.2 million as of December 31, 2023, a decrease of about 10.9% from RMB 986.5 million as of December 31, 2022, primarily due to increased operating and capital expenditures[96] - The total borrowings amounted to RMB 10.0 million as of December 31, 2023, compared to zero as of December 31, 2022[97] - The debt-to-equity ratio increased from approximately 10.5% as of December 31, 2022, to approximately 24.3% as of December 31, 2023, mainly due to an increase in lease liabilities[97] Corporate Governance and Future Plans - The board of directors did not recommend a final dividend for the year ended December 31, 2023[43] - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[110] - The audit committee has reviewed the audited consolidated financial statements for the year and confirmed they were prepared in accordance with applicable accounting standards and regulations[112] - The annual performance announcement and the 2023 annual report will be published on the Stock Exchange and the company's website[113] - The company will continue to participate in international vascular intervention conferences and academic activities to promote its products and brand globally[107]

Financial Performance - Revenue for the six months ended June 30, 2023, reached RMB 243.1 million, an increase of 38.6% compared to RMB 175.3 million for the same period in 2022[7]. - Gross profit for the same period was RMB 195.1 million, reflecting a growth of 34.8% from RMB 144.8 million year-on-year[7]. - Adjusted net profit for the period was RMB 35.7 million, an increase of 83.8% compared to RMB 19.4 million in the previous year[7]. - Revenue from sales of AcoArt Orchid® & Dhalia® in China and overseas was approximately RMB 126.2 million, an increase of about 2.0% year-on-year[19]. - Revenue from sales of venous intervention and vascular access products was approximately RMB 88.9 million, an increase of about 190.9% year-on-year[25]. - Revenue from core products and venous intervention products was approximately RMB 152.9 million and RMB 88.9 million, representing increases of approximately 7.0% and 190.9%, respectively[41]. - The gross profit increased by approximately 34.8% to about RMB 195.1 million for the six months ended June 30, 2023, with a gross margin of approximately 80.3%, down from 82.6% in the same period of 2022[47]. - The company recorded a net loss of approximately RMB 7.1 million in other income for the six months ended June 30, 2023, compared to a net gain of RMB 15.1 million in the same period of 2022, primarily due to foreign exchange losses[49]. - The company reported a total comprehensive income of RMB 23,890 thousand for the period, compared to RMB 31,189 thousand in the same period last year[94]. Product Development and Innovation - The company is focused on continuous innovation and clinical promotion in vascular intervention therapies, aiming to provide new treatment solutions[10]. - The product pipeline is progressing as planned, with ongoing developments in various therapeutic areas[11]. - The company has a total of 14 commercialized products and 18 products under development, categorized as Class I, II, and III medical devices by the National Medical Products Administration[14]. - The company aims to enhance its global market reputation and expand revenue sources through the framework agreement with BSC[12]. - The company plans to expand its product offerings in five treatment areas, including vascular surgery, cardiology, nephrology, neurology, and urology, by broadening the indications for DCB products[43]. - The company is focused on expanding its core products and commercializing them in new markets[16]. - The company is developing a peripheral thrombectomy device, with expected NMPA approval in 2025[27]. - The company is developing a coronary IVL system aimed at reducing stent implantation rates, with expected NMPA approval in 2026[32]. Market Expansion and Internationalization - The company has successfully expanded its hospital admissions, with ATK DCB reaching 1,501 hospitals and BTK DCB reaching 750 hospitals as of June 30, 2023[9]. - The company has commercialized its products in 14 overseas countries, enhancing revenue diversification and market adaptability[9]. - The company aims to accelerate its internationalization process to further diversify its business and revenue sources[9]. - As of June 30, 2023, AcoArt Orchid® has been launched in 14 countries, including Germany, Italy, Switzerland, and Brazil, following regulatory approvals[18]. - The company has successfully launched AcoArt Tulip® & Litos® in 12 additional countries as of June 30, 2023[20]. Research and Development - Research and development costs for the six months ended June 30, 2023, were approximately RMB 89.9 million, an increase of about 16.6% compared to RMB 77.1 million for the same period in 2022[51]. - The company continues to focus on the research and development of treatment solutions for vascular diseases as its primary business[105]. - The company has been engaged in research and development of treatment solutions for vascular diseases, with its main operational location in Beijing, China[102]. Corporate Governance and Shareholder Information - The company has adopted a corporate governance code and has complied with all applicable provisions, except for the separation of the roles of Chairman and CEO[72]. - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[72]. - Boston Scientific became the controlling shareholder of the company with a 65% stake as of February 9, 2023, following a partial offer to shareholders[151]. - The company has entered into a total cooperation agreement and a total service agreement with its controlling shareholder, BSG, which holds approximately 65.0% of the company's issued share capital[66]. Financial Position and Cash Flow - Cash and cash equivalents as of June 30, 2023, were approximately RMB 947.8 million, a decrease of about 3.9% from RMB 986.5 million as of December 31, 2022[60]. - The capital-to-debt ratio increased from approximately 10.5% as of December 31, 2022, to about 22.9% as of June 30, 2023, primarily due to an increase in lease liabilities[61]. - The company reported a net cash generated from operating activities for the six months ended June 30, 2023, is RMB 9,918 thousand, a significant improvement from RMB (36,707) thousand for the same period in 2022[101]. - The company incurred RMB 25,733 thousand in payments for the purchase of property, plant, and equipment, and intangible assets during the first half of 2023, compared to RMB 17,335 thousand in the same period of 2022[101]. - The company’s total equity as of June 30, 2023, is RMB 1,276,089 thousand, an increase from RMB 1,225,309 thousand as of December 31, 2022, representing a growth of approximately 4.1%[99]. Employee and Training Initiatives - The total number of employees as of June 30, 2023, was 645, with ongoing efforts to enhance team capabilities and professional skills[10]. - The company has established a comprehensive training system to support employee growth and skill enhancement[10]. Regulatory Approvals and Compliance - Four products received approval from the National Medical Products Administration in the first half of 2023, including the second-generation peripheral suction system (AcoStream® II) and two cardiac products (RT-Zero® and Vericor-14®)[13]. - The company is exempt from clinical trial requirements based on the revised catalog issued by the NMPA[16]. - The company has received registration approval from the Thai Food and Drug Administration for the peripheral support catheter (Vericor®)[13].

[Peijia Medical Technology (Holdings) Limited 2022 Annual Report Supplemental Announcement](index=1&type=section&id=Supplemental%20Announcement%20to%20the%20Annual%20Report%20for%20the%20Year%20Ended%20December%2031%2C%202022) This supplemental announcement provides additional details regarding the company's restricted share unit and share award schemes for the year ended December 31, 2022 [Background and Purpose of the Announcement](index=1&type=section&id=Announcement%20Background) This announcement supplements Peijia Medical Technology (Holdings) Limited's 2022 annual report, providing additional details on the company's restricted share unit and share award schemes - This announcement is a supplement to Peijia Medical Technology (Holdings) Limited's annual report for the year ended December 31, 2022, published on April 24, 2023[2](index=2&type=chunk) - The supplementary content primarily concerns information related to the company's restricted share unit scheme and share award scheme[2](index=2&type=chunk) [Changes in Restricted Share Unit Scheme](index=1&type=section&id=Restricted%20Share%20Unit%20Scheme) During the reporting period, changes occurred in the company's restricted share unit scheme, primarily involving forfeiture of shares due to employee resignations Changes in Restricted Share Unit Scheme (During Reporting Period) | Grantees | Cancelled during reporting period (shares) | Lapsed during reporting period (shares) | Forfeited during reporting period (shares) | | :------------ | :----------------------------------------- | :-------------------------------------- | :----------------------------------------- | | 55 Employees | | 60,000 | (See attached) | | Two Employees | | N/A | | | Nine Employees | | N/A | | | Total | | 60,000 | | - Due to the resignation of certain grantees (55 employees) from the company, **60,000 restricted shares** were forfeited[3](index=3&type=chunk) [Details of Share Award Scheme](index=2&type=section&id=Share%20Award%20Scheme) The share award scheme aims to incentivize employees and directors contributing to the group, defining eligibility and the scheme's effective duration [Participant Eligibility](index=2&type=section&id=Participants%20of%20the%20Share%20Award%20Scheme) Eligibility for the share award scheme extends to employees and directors who have contributed or are expected to contribute to the group - Participants include full-time or part-time employees and directors of any member company within the group, provided the Board or authorized persons, at their sole discretion, deem they have contributed or will contribute to the group[4](index=4&type=chunk) - Individuals are ineligible if local laws and regulations prohibit the grant, acceptance, or vesting of awards, or if the Board determines that compliance would lead to exclusion[4](index=4&type=chunk) [Remaining Term of the Scheme](index=2&type=section&id=Remaining%20Term%20of%20the%20Share%20Award%20Scheme) The share award scheme's validity extends for ten years from its adoption date, with approximately nine years remaining at the reporting period end - The share award scheme is effective and valid from its adoption date until the business day immediately preceding the tenth anniversary of the adoption date[5](index=5&type=chunk) - As of the end of the reporting period, the remaining term of the share award scheme is approximately **nine years**[5](index=5&type=chunk) [Other Information and Board Composition](index=2&type=section&id=Other%20Information) This supplemental announcement's additional information does not alter other content in the annual report and lists the Board of Directors as of the announcement date - The additional information contained in this announcement does not affect other information in the annual report, and all other information in the annual report remains unchanged[5](index=5&type=chunk) - The announcement lists the Executive Directors (Ms. LI Jing, Mr. Silvio Rudolf SCHAFFNER), Non-executive Directors (Mr. Arthur Crosswell BUTCHER, Ms. June CHANG), and Independent Non-executive Directors (Dr. WANG Yuqi, Ms. NI Hong, Ms. PAN Jianer) as of the announcement date[5](index=5&type=chunk)

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 243,063 thousand, representing a 38.6% increase from RMB 175,322 thousand in the same period of 2022[2] - Gross profit for the same period was RMB 195,116 thousand, up 34.8% from RMB 144,770 thousand year-on-year[2] - Profit before tax decreased by 28.6% to RMB 22,351 thousand compared to RMB 31,290 thousand in the previous year[2] - Net profit for the period was RMB 22,369 thousand, down 28.1% from RMB 31,096 thousand in the prior year[2] - Adjusted net profit increased by 83.8% to RMB 35,715 thousand from RMB 19,430 thousand year-on-year[2] - The company reported a total comprehensive income of RMB 23,890 thousand for the period, compared to RMB 31,189 thousand in the previous year[6] - The company reported external customer revenue from mainland China of RMB 236,974,000, a 38.5% increase from RMB 171,048,000 in the prior year[20] - The company reported a net loss of RMB 8,086,000 in foreign exchange gains/losses for the six months ended June 30, 2023, compared to a gain of RMB 15,152,000 in the same period of 2022[24] - The total finance costs for the six months ended June 30, 2023, amounted to RMB 4,357,000, significantly higher than RMB 866,000 in the previous year[25] - The company recorded a net other loss of approximately RMB 7.1 million for the six months ended June 30, 2023, compared to a net other income of RMB 15.1 million for the same period in 2022, primarily due to foreign exchange losses[80] Assets and Liabilities - Non-current assets increased significantly, with property, plant, and equipment valued at RMB 87,100 thousand, up from RMB 68,928 thousand[7] - Current assets totaled RMB 1,229,104 thousand, slightly down from RMB 1,256,438 thousand at the end of 2022[7] - Total equity attributable to shareholders increased to RMB 1,305,239 thousand from RMB 1,276,089 thousand[10] - The total non-current assets as of June 30, 2023, were RMB 339,840,000, compared to RMB 129,769,000 as of December 31, 2022[18] - Trade receivables, net of loss provisions, stood at RMB 116,507,000 as of June 30, 2023, compared to RMB 131,909,000 at the end of 2022[34] - The total amount of trade and other payables decreased to RMB 57.111 million from RMB 74.090 million as of December 31, 2022[35] - Cash and cash equivalents as of June 30, 2023, were approximately RMB 947.8 million, a decrease of about 3.9% from RMB 986.5 million as of December 31, 2022[92] - The net current assets of the group were approximately RMB 1,141.0 million as of June 30, 2023, a decrease of about 1.4% from RMB 1,157.8 million as of December 31, 2022[94] - The capital-to-debt ratio increased from approximately 10.5% as of December 31, 2022, to about 22.9% as of June 30, 2023, primarily due to an increase in lease liabilities[93] Research and Development - Research and development expenses rose to RMB 89,877 thousand, compared to RMB 77,070 thousand in the same period last year[4] - The company operates primarily in the blood-related disease treatment solutions sector, focusing on research and development[15] - The company is actively advancing its product pipeline, focusing on arterial diseases, venous diseases, and vascular tumors[43] - R&D expenses for the six months ended June 30, 2023, were approximately RMB 89.9 million, an increase of about 16.6% compared to RMB 77.1 million for the same period in 2022[82] - Employee benefits accounted for 44.6% of R&D expenses in 2023, up from 37.5% in 2022, reflecting increased personnel costs[83] - The company aims to enhance its R&D capabilities by increasing investment in technological innovation to strengthen its competitive position in the DCB market[73] Product Development and Approvals - In the first half of 2023, the company received approvals for four products from the National Medical Products Administration, enhancing its market presence[45] - The second-generation peripheral suction system (AcoStream®) was launched, offering improved therapeutic effects and ease of use compared to the first generation[45] - The company obtained approvals for two cardiac products: the coronary CTO recanalization balloon (RT-Zero®) and the coronary CTO retrograde microcatheter (Vericor-14®)[45] - The company’s paclitaxel-coated high-pressure balloon (ACOART AVENS®) received approval, strengthening its influence in the renal field[45] - The company has a total of 14 commercialized products and 18 products in development across three therapeutic areas[46] - The company is expanding the indications for AcoArt Orchid® & Dhalia® in treating vertebral artery atherosclerotic stenosis, with RCT enrollment completed in 2022 and expected approval in 2024[49] Market and Sales Performance - Revenue from core products, specifically drug-coated balloons (DCB), was RMB 152,874,000, up from RMB 142,898,000, indicating a growth of 7.4%[16] - Revenue from vascular intervention and access products surged to RMB 88,939,000, a significant increase from RMB 30,575,000, reflecting a growth of 190.5%[16] - Other commercialized products, including AcoStream® and AcoArt Cedar®, generated approximately RMB 88.9 million in revenue, accounting for about 36.6% of total revenue during the reporting period[40] - Sales from core products AcoArt Orchid® & Dhalia® and AcoArt Tulip® & Litos® generated approximately RMB 152.9 million, reflecting a year-on-year increase of about 7.0%[71] - Sales from venous intervention and vascular access products amounted to approximately RMB 88.9 million, with a significant year-on-year increase of about 190.9%[71] Corporate Governance and Strategy - The company maintains a high level of corporate governance to protect shareholder interests and enhance corporate value[105] - The board believes that the current structure, with the same individual serving as both Chair and CEO, ensures effective leadership and strategic planning[105] - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[105] - The company is exploring strategic acquisitions to bolster its market position[112] - The company has strengthened its talent pool in hardware design, engineering, and materials science during the reporting period[70] Future Outlook - Future outlook includes expansion in the market and potential new product launches[112] - The company has set performance guidance for the upcoming quarters, anticipating growth in revenue[112] - The company expects to generate more cash from operating activities through increased sales of existing commercialized products and the launch of new products[92] - The company plans to expand its product offerings in five therapeutic areas, including vascular surgery, cardiology, nephrology, neurology, and urology, by increasing the indications for DCB products[73]

Financial Performance - For the fiscal year ending December 31, 2022, the total revenue was approximately RMB 395.5 million, representing a year-on-year increase of 30.2%[6] - Gross profit for the same period was approximately RMB 336.4 million, with a year-on-year growth of 26.5%[6] - The net profit for the year was approximately RMB 70.1 million, a significant recovery from a loss of RMB 79.1 million in the previous year[6] - The company achieved a revenue of approximately RMB 395.5 million in 2022, representing a year-on-year increase of about 30.2%[12] - Revenue from AcoArt Orchid® & Dhalia® sales in China and overseas was approximately RMB 270.8 million, representing a decrease of about 1.5% year-on-year[23] - Revenue from core products and venous intervention products was approximately RMB 307.3 million and RMB 86.0 million, representing increases of approximately 2.7% and 1,763.8%, respectively[40] - The company's revenue for the year ended December 31, 2022, was approximately RMB 395.5 million, an increase of about 30.2% compared to RMB 303.8 million for the year ended December 31, 2021[44] Product Development and Innovation - The company received approval for five new products and one DCB product indication expansion from the National Medical Products Administration in 2022[8] - The company has submitted 18 patent applications during the reporting period, with 4 applications already approved[12] - The company has launched five new products and received NMPA registration approvals for these products during the reporting period[16] - The company has expanded its product coverage to include cardiology, nephrology, and neurology, in addition to peripheral vascular diseases[12] - The company is focused on accelerating its internationalization process to diversify its revenue sources and respond flexibly to market changes[12] - The company is expanding the indications for AcoArt Orchid® & Dhalia® in treating vascular-related erectile dysfunction[25] - The company is expanding its core products AcoArt Orchid® & Dhalia® and AcoArt Tulip® & Litos® for the treatment of vascular erectile dysfunction, with expected regulatory approval in 2025[38] Financial Position and Assets - Total assets as of December 31, 2022, were RMB 1.41 billion, a 7.9% increase from the previous year[7] - Total liabilities increased by 34.2% to RMB 134.5 million, with current liabilities rising by 12.0%[7] - The total equity amounted to RMB 1.28 billion, reflecting a 5.7% increase year-on-year[7] - Cash and cash equivalents as of December 31, 2022, were approximately RMB 986.5 million, a decrease of about 13.3% from RMB 1,137.2 million in 2021, attributed to increased operating and investment expenditures[61] - The company's total borrowings were zero as of December 31, 2022, down from approximately RMB 6.0 million in the previous year[62] - The debt-to-equity ratio increased from approximately 8.3% in 2021 to about 10.5% in 2022[62] Research and Development - The company’s R&D team has grown to 118 members, enhancing its talent pool in various technical fields[14] - Research and development expenses for the year ended December 31, 2022, were approximately RMB 183.8 million, an increase of about 30.1% from RMB 141.3 million in 2021, driven by the acquisition of R&D centers and increased investment in ongoing projects[51] - The company is committed to clinical research and development to advance its product offerings and improve patient outcomes[90] Market Expansion and Strategy - The company aims to become a global leader in vascular disease intervention solutions, planning to expand DCB product indications across five treatment areas[43] - The company plans to enhance sales efforts for AcoArt Orchid® & Dhalia® and improve awareness of DCB products among patients in China[43] - The company intends to accelerate clinical development and commercialization of late-stage products while expanding sales penetration globally, particularly in Europe and the United States[43] - The company plans to continue expanding in both domestic and global markets and will support capital expenditures through various financing channels, including internal funds and bank loans[66] Governance and Management - The board of directors consists of seven members, including two executive directors and three independent non-executive directors, ensuring a balanced governance structure[157] - The company emphasizes high corporate governance standards and has adopted the principles and code provisions of the corporate governance code as per the listing rules[155] - The company has established three committees: the audit committee, the remuneration committee, and the nomination committee, each with defined responsibilities and reporting to the board[167] - The company has implemented various occupational health and safety procedures to maintain a safe working environment, with no significant claims or disputes reported[98] Risks and Compliance - The company faced significant risks including the lengthy and costly clinical product development process, which may lead to additional costs or delays[95] - The company has established various risk management procedures and internal control processes across major business and functional departments, including sales, procurement, and financial management[178] - The company has ensured that all directors confirmed compliance with the code of conduct regarding securities trading during the reporting period[180] Shareholder Relations - The company emphasizes the importance of effective communication with shareholders to enhance investor relations and ensure transparency in financial disclosures[184] - The company has set up various communication channels to respond to stakeholder inquiries effectively[193] - The board of directors will regularly review the company's status and consider adopting a dividend policy at an appropriate time[194]

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 395.5 million, representing a year-on-year increase of 30.2%[3] - Gross profit for the same period was RMB 336.4 million, up 26.5% from RMB 265.9 million in 2021[3] - Adjusted net profit for the year was RMB 85.7 million, a significant increase of 159.3% compared to RMB 33.0 million in the previous year[3] - The company reported a net profit of RMB 70,142 thousand in 2022, a significant recovery from a net loss of RMB 79,077 thousand in 2021[8] - The total comprehensive income for the year was RMB 70,204 thousand, recovering from a loss of RMB 79,077 thousand in the previous year[9] - The company reported other income of RMB 28,143 thousand in 2022, compared to RMB 11,433 thousand in 2021, reflecting growth in ancillary revenue streams[7] - The company reported a pre-tax profit of RMB 51,989 thousand in 2022, compared to a pre-tax loss of RMB 8,837 thousand in 2021[30] - The company reported a significant increase in work-in-progress inventory to RMB 6,614,000 in 2022 from RMB 3,197,000 in 2021[41] - The company recognized a tax expense of RMB 177,000 in 2022, a significant decrease from RMB 11,834,000 in 2021[37] - The company recorded a net other income of approximately RMB 52.0 million for the year ended December 31, 2022, compared to a loss of RMB 8.8 million for the year ended December 31, 2021[92] Product Development and Innovation - The company has submitted 18 patent applications, with 4 approved as of December 31, 2022[4] - The core products AcoArt Orchid® & Dhalia® contributed significantly to revenue growth, with new product launches in 2022[5] - The company is diversifying its product pipeline, with five therapeutic areas under development and multiple products launched in 2022[5] - The company has expanded into three new therapeutic areas: neurology, cardiology, and nephrology, reflecting its growth strategy[5] - The company has developed over 30 products across five major medical fields, focusing on minimally invasive intervention solutions[48] - Five new products and the expansion of indications for AcoArt Orchid® & Dhalia® received NMPA registration approval during the reporting period[53] - The company launched the AcoArt Cedar® varicose vein radiofrequency ablation system in April 2022, becoming the only Chinese company with original research technology in this field[53] - The PTA balloon (P-Conic®), intracranial PTA balloon (NEO-Skater®), and compliant PTCA balloon (YAN) also received approval from the National Medical Products Administration during the reporting period[53] - The company plans to obtain approval for AcoArt Orchid® & Dhalia® in the neurology field in 2024[58] - The company has a strong internal R&D team with 43 registered patents and 32 pending patents as of December 31, 2022[77] Market Expansion and Sales Growth - The company achieved 1,400 hospital admissions for ATK DCB, an increase from 1,283 hospitals as of December 31, 2021[5] - The company has commercialized its products in a total of 13 countries globally as of December 31, 2022, diversifying its revenue sources[50] - Revenue from vascular intervention and vascular access products surged to RMB 86,033,000, compared to RMB 4,616,000 in the previous year, reflecting a significant increase of approximately 1,862.5%[23] - The company plans to expand its product offerings in five therapeutic areas, including vascular surgery, cardiology, nephrology, neurology, and urology[85] - The company plans to accelerate the clinical development and commercialization of its late-stage products to gain first-mover advantages[85] - The company is actively pursuing market cultivation for new products to provide innovative treatment solutions for clinical patients[50] - The company plans to expand sales in China by increasing sales efforts and providing systematic training to hospitals and doctors[117] - The company aims to enhance its R&D capabilities through increased investment in technological innovation to solidify its leading position in the DCB market[85] Financial Position and Management - As of December 31, 2022, total assets amounted to RMB 1,311,870 thousand, compared to RMB 1,219,254 thousand in 2021[10] - The company has made significant investments in property, plant, and equipment, with a total of RMB 68,928 thousand as of December 31, 2022, up from RMB 16,836 thousand in 2021[10] - The company’s net property, plant, and equipment value reached RMB 68,928,000 as of December 31, 2022, up from RMB 33,398,000 in 2021[40] - The company has sufficient bank credit facilities to support its capital expenditures[112] - The company has adopted a conservative treasury policy for cash and financial management, primarily holding deposits in USD, HKD, and RMB[104] - The company faces foreign exchange risks but currently has no hedging policy in place[107] - The total borrowings as of December 31, 2022, were zero, compared to approximately RMB 6.0 million as of December 31, 2021[105] - The capital debt ratio increased from approximately 8.3% as of December 31, 2021, to about 10.5% as of December 31, 2022[105] Corporate Governance and Compliance - The company is committed to maintaining high levels of corporate governance to protect shareholder interests and enhance corporate value[119] - The company has adopted a standard code for securities trading, confirming compliance by all directors during the reporting period[121] - The audit committee has reviewed the audited consolidated financial statements for the year and confirmed their compliance with applicable accounting standards[124] - The annual performance announcement will be published on the stock exchange and the company's website, with the annual report sent to shareholders[125] Future Outlook - The company provided guidance for the upcoming fiscal year, projecting revenue growth of BB% and aiming for a total revenue of $CC million[129] - The company is investing in R&D for new technologies, with a budget allocation of $DD million for the next fiscal year[129] - Market expansion efforts are underway, targeting new regions with a projected market share increase of EE%[128] - The company is exploring potential acquisitions to enhance its product portfolio and market presence, with a focus on strategic partnerships[129] - The company plans to promote its products through appropriate marketing and academic activities to expand its reach among physicians and patients in China[116]

Financial Performance - Revenue for the six months ended June 30, 2022, reached RMB 175.3 million, a 25.1% increase compared to the same period in 2021[5] - Gross profit for the period was RMB 144.8 million, up 17.1% year-over-year[5] - The company achieved a net profit of RMB 31.1 million for the six months ended June 30, 2022, compared to a net loss of RMB 12.5 million in the same period of 2021[5] - Revenue for the six months ended June 30, 2022, was approximately RMB 175.3 million, a 25.1% increase compared to RMB 140.2 million in the same period in 2021, driven by increased sales of core products and new product launches[37] - Gross profit increased by 17.1% to RMB 144.8 million in the six months ended June 30, 2022, with a gross margin of 82.6%, down from 88.2% in the same period in 2021 due to lower-priced venous intervention and vascular access products[40] - Revenue for the six months ended June 30, 2022, was RMB 175.322 million, a significant increase from RMB 140.195 million in the same period last year[75] - Gross profit for the period was RMB 144.770 million, up from RMB 123.677 million in the previous year[75] - Net profit for the six months ended June 30, 2022, was RMB 31.096 million, compared to a net loss of RMB 12.536 million in the same period last year[75] - Basic earnings per share for the period were RMB 0.10, compared to a loss per share of RMB 0.06 in the same period last year[75] - Total comprehensive income for the period was RMB 31,189 thousand, compared to a loss of RMB 12,536 thousand in the previous period[79] - Core product revenue increased to RMB 142,898 thousand in H1 2022, up from RMB 138,300 thousand in H1 2021[92] - Venous intervention and vascular access products revenue surged to RMB 30,575 thousand in H1 2022, compared to RMB 1,863 thousand in H1 2021[92] - Total revenue from external customers in Mainland China reached RMB 171,048 thousand in H1 2022, up from RMB 136,933 thousand in H1 2021[94] - Basic earnings per share improved to RMB 0.104 in H1 2022, compared to a loss per share of RMB 0.057 in H1 2021[102] Product Development and Commercialization - The company's SFA DCB product was admitted to 1,400 hospitals as of June 30, 2022, up from 1,238 hospitals at the end of 2021[7] - BTK DCB product was admitted to 650 hospitals, a significant increase from 288 hospitals at the end of 2021[7] - The company's products have been commercialized in 12 countries globally as of June 30, 2022[8] - Other commercialized products, including AcoStream™ and PTA balloons, contributed approximately RMB 30.6 million in revenue during the reporting period[8] - Core products AcoArt Orchid® & Dhalia™ and AcoArt Tulip™ & Litos™ remained the primary revenue drivers[7] - The company's new product pipeline is progressing rapidly, with a focus on arterial diseases, venous diseases, and vascular tumor markets[10] - The company launched its peripheral thrombus aspiration system, making it the only Chinese enterprise with original technology and a comprehensive solution in this field[11] - The company has 7 commercialized products and 26 products in the pipeline, covering first, second, and third-class medical devices under the NMPA classification[12] - AcoArt Orchid® & Dhalia™ received CE marking in 2014 and NMPA approval in 2016, and has been launched in 12 countries including Germany, Italy, and Brazil[14] - The company expanded the indications of AcoArt Orchid® & Dhalia™ to treat AVF stenosis, with a 91.4% patency rate at 6 months and 66.1% at 12 months in the DCB group[14] - The company expects to receive NMPA approval for AcoArt Orchid® & Dhalia™ in the neurology field by 2024[14] - The company's peripheral support catheter and PTA balloons for above and below the knee are expected to be commercialized in 2022[13] - The company's next-generation thrombus aspiration system is expected to be commercialized in 2023[13] - The company's peripheral IVL system for vascular calcification is expected to be commercialized in 2026[13] - The company's coronary IVL system for coronary calcification is expected to be commercialized in 2026[13] - The company's intracranial PTA balloon is expected to be commercialized in 2022[13] - AcoArt Orchid® & DhaliaTM generated revenue of approximately RMB 123.8 million during the reporting period, representing a year-on-year increase of 0.9%[15] - AcoArt TulipTM & LitosTM generated revenue of approximately RMB 19.1 million during the reporting period, representing a year-on-year increase of 22.7%[16] - AcoArt TulipTM & LitosTM has been launched in 12 countries including Germany, Italy, Switzerland, and Brazil as of June 30, 2022[16] - The company submitted an IDE application to the FDA for AcoArt LitosTM in January 2022 and is currently screening business partners for clinical trials in the U.S.[16] - The company has 5 commercialized products and 12 pipeline products in the vascular surgery field, 10 pipeline products in cardiology, 2 in nephrology, and 2 in neurology[17] - AcoArt IrisTM & JasminTM and AcoArt LilyTM & RosmarinTM are among the 5 commercialized products in the vascular surgery field[18][19] - Revenue from venous intervention and vascular access products, including AcoArt IrisTM & JasminTM, AcoArt LilyTM & RosmarinTM, AcoStreamTM, and AcoArt CedarTM, was approximately RMB 30.6 million during the reporting period[20] - The company expects to submit product registration applications for the above-knee PTA balloon and below-knee PTA balloon to the NMPA in 2022[21] - The company plans to submit a product registration application for the peripheral three-wire balloon to the NMPA in 2022 and expects approval in 2023[21] - Peripheral Rotational Atherectomy Device is in the preclinical research stage, with expected submission for product registration to the National Medical Products Administration (NMPA) in 2023 and approval expected in 2025[22] - Peripheral Spot Stent is undergoing clinical trials, with NMPA approval expected in 2024[22] - Lower Limb Rapamycin DCB is currently enrolling patients, with NMPA approval expected in 2025[22] - Peripheral Scoring Balloon is in the preclinical research stage, with product registration submission expected in 2022 and NMPA approval expected in 2023[22] - Second-generation Peripheral Aspiration System is under development, with NMPA approval expected in 2023[22] - Peripheral IVL System is under development, with NMPA approval expected in 2026[22] - Coronary CTO Antegrade Microcatheter is under development, with NMPA approval expected in 2023[24] - Coronary CTO Re-entry Balloon, with a diameter of 0.8mm, is under development and expected to receive NMPA approval in 2023[24] - Coronary Dual Lumen Selective Microcatheter is under development, with product registration submission expected in 2022 and NMPA approval expected in 2023[24] - Coronary Retrograde Microcatheter is under development, with product registration submission and NMPA approval expected in 2023[24] - AcoArt DaisyTM, a rapid exchange system DCB for treating intracranial atherosclerotic stenosis (ICAS), has recruited 10 patients for RCT as of June 30, 2022, with expected completion in 2022 and anticipated NMPA approval by 2024[28] - The company's intracranial PTA balloon, optimized for navigating tortuous and narrow vascular environments, has been submitted for type testing with expected NMPA approval in 2022[28] - AcoArt Orchid® & DhaliaTM and AcoArt TulipTM & LitosTM are being expanded for treating vasculogenic ED, with clinical trials expected to begin and NMPA approval anticipated by 2025[29] R&D and Innovation - The company's total number of employees reached 534 as of June 30, 2022, with expanded technical expertise in electronics, automation, and computer programming[9] - R&D costs increased by 25.6% to RMB 77.1 million in the six months ended June 30, 2022, driven by the integration of new R&D centers and increased investment in ongoing projects[44] - R&D expenses increased to RMB 77.070 million from RMB 61.375 million in the previous year, reflecting continued investment in innovation[75] - The company aims to expand its product offerings across five therapeutic areas (vascular surgery, cardiology, nephrology, neurology, and andrology) and increase investment in technological innovation to enhance R&D capabilities[36] - The company has a robust intellectual property portfolio, including 35 registered patents and 26 pending patent applications as of June 30, 2022[30] - The company has 35 registered patents, 50 registered trademarks, 26 pending patent applications, and 43 pending trademark applications as of June 30, 2022[34] - The company plans to expand its product pipeline through internal development, mergers and acquisitions, and other financing channels, with sufficient bank credit lines currently available[55] Sales and Distribution - Sales of DCB products accounted for 81.5% of total revenue in the six months ended June 30, 2022, down from 98.6% in the same period in 2021, reflecting diversification into venous intervention and vascular access products[37] - The company plans to expand sales of AcoArt Orchid® & DhaliaTM, deepen hospital penetration, and increase awareness of DCB among hospitals, doctors, and patients in China[36] - Sales and distribution costs decreased by 13.3% to RMB 24.7 million in the six months ended June 30, 2022, due to reduced share-based compensation and lower business travel expenses[43] Financial Position and Cash Flow - Cash and cash equivalents decreased by 6.6% to RMB 1,062.6 million as of June 30, 2022, compared to RMB 1,137.2 million as of December 31, 2021, primarily due to increased operating expenses[51] - The company's capital expenditure totaled RMB 18.2 million during the reporting period, allocated for purchasing plant and equipment, rental deposits, and intangible assets[54] - The company's capital-to-debt ratio decreased from 8.3% as of December 31, 2021, to 7.7% as of June 30, 2022[52] - Net proceeds from the global offering and the full exercise of the over-allotment option amounted to RMB 1,294.0 million, with RMB 273.1 million utilized as of June 30, 2022[56] - The company's net current assets increased by 0.3% to RMB 1,159.1 million as of June 30, 2022, compared to RMB 1,155.4 million as of December 31, 2021[52] - The company has no contingent liabilities or asset mortgages as of June 30, 2022[54] - Non-current assets increased to RMB 90,067 thousand as of June 30, 2022, up from RMB 63,841 thousand as of December 31, 2021[80] - Current assets stood at RMB 1,229,015 thousand as of June 30, 2022, slightly down from RMB 1,243,525 thousand as of December 31, 2021[80] - Cash and cash equivalents decreased to RMB 1,062,621 thousand as of June 30, 2022, from RMB 1,137,184 thousand as of December 31, 2021[80] - Net current assets increased to RMB 1,159,111 thousand as of June 30, 2022, compared to RMB 1,155,413 thousand as of December 31, 2021[80] - Total assets minus current liabilities rose to RMB 1,249,178 thousand as of June 30, 2022, from RMB 1,219,254 thousand as of December 31, 2021[80] - Non-current liabilities increased to RMB 23,869 thousand as of June 30, 2022, up from RMB 12,060 thousand as of December 31, 2021[81] - Total equity attributable to equity shareholders of the company was RMB 1,225,309 thousand as of June 30, 2022, compared to RMB 1,207,194 thousand as of December 31, 2021[81] - Accumulated losses increased to RMB 268,835 thousand as of June 30, 2022, from RMB 202,294 thousand as of December 31, 2021[84] - Total equity increased to RMB 1,225,309 thousand, up from RMB 1,207,194 thousand[86] - Accumulated losses decreased to RMB (237,739) thousand from RMB (268,835) thousand[86] - Cash and cash equivalents decreased by RMB 74,656 thousand to RMB 1,062,621 thousand[88] - Operating activities used RMB 36,707 thousand in cash, compared to generating RMB 21,033 thousand in the same period last year[87] - Investment activities used RMB 10,418 thousand in cash, a decrease from RMB 13,161 thousand in the previous year[87] - Financing activities used RMB 27,531 thousand in cash, a significant reduction from RMB 131,103 thousand in the prior year[87] - The company issued shares under the employee incentive platform, raising RMB 72,746 thousand in the previous year[87] - The company paid RMB 16,560 thousand for repurchasing shares under the share incentive plan[87] - The company's cash flow from operating activities was negatively impacted by a tax payment of RMB 5,072 thousand[87] - The company's cash flow from investment activities was affected by payments for property, plant, and equipment amounting to RMB 17,335 thousand[87] Corporate Governance and Shareholding - The company's Chairman and CEO positions are both held by Ms. Li Jing, with the Board believing this structure does not weaken the balance of power between the Board and management[59] - The company expects to retain all future profits for business operations and expansion, with no immediate plans to adopt a dividend policy[59] - As of June 30, 2022, Ms. Li Jing holds 55,291,087 shares, representing approximately 17.64% of the company's total issued shares[63] - CA Medtech Investment (Cayman) Limited holds 158,614,642 shares, representing approximately 50.61% of the company's total issued shares[66] - CPEChina Fund III, L.P. holds 161,877,642 shares, representing approximately 51.65% of the company's total issued shares[66] - Cosmic Elite Holdings Limited holds 43,062,647 shares, representing approximately 13.74% of the company's total issued shares[66] - The company's total issued shares as of June 30, 2022, were 313,389,171[67] - CPE Investment Wu Limited holds 3,263,000 shares, representing 85.61% ownership by CPEChina Fund III and 14.39% by CPE Global Opportunities Fund[67] - The company's financial statements for the six months ended June 30, 2022, were reviewed by KPMG, with no significant issues identified[74] - The company did not engage in any significant purchases, sales, or redemptions of listed securities during the reporting period[70] - The company's IPO was successfully completed on August 24, 2021, with shares listed and traded on the Hong Kong Stock Exchange[126] - The reporting period for the interim report is the six months ended June 30, 2022[127] - The company's shares have a par value of $0.00001 per share[127] - The company operates under the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board[126] - The company is involved in the development and clinical research of medical devices, including those under the FDA's Investigational Device Exemption (IDE) program[126] - The company focuses on treatments for conditions such as Hemodialysis (HD), Lower Extremity Arterial Disease (LEAD), and Peripheral Arterial Disease (PAD)[126] - The company's financial reporting is conducted in both Hong Kong Dollars (HKD) and Renminbi (RMB)[127] - The company adheres to the Hong Kong Stock Exchange's Listing Rules and the Model Code for Securities Transactions by Directors of Listed Issuers[126] - The company's operations are subject to the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong)[127] - The company's shares are denominated in US dollars, with a par value of $0.00001 per share[127] Employee and Incentive Programs - The company employs a total of 534 employees, with the majority based in China, and offers competitive compensation and incentive programs[54] - The company repurchased 2,004,000 shares at an average price of HKD 9.94 per share (approximately RMB 8.26) under the share incentive plan[70] - The company issued 1,540,000 restricted shares to 55 eligible employees under the Restricted Share Unit Plan, with 50% vesting on the first anniversary and the remaining 50% on the second anniversary of the grant date[118] - The expected retention rate for employees under the Restricted Share Unit Plan was assessed to be between 82% and 84% as of June 30, 2022[118] - The company deducted RMB 3,486,000 from its income statement for the six months ended June 30, 2022, related

Financial Performance - Revenue for the year ended December 31, 2021, was RMB 303.8 million, a 56.6% increase compared to RMB 194.0 million in 2020[7] - Gross profit for 2021 was RMB 265.9 million, up 62.4% from RMB 163.8 million in 2020[6] - The company's adjusted net profit for 2021 was RMB 42.4 million, a 141.8% increase from RMB 17.5 million in 2020[6] - Revenue for the year ended December 31, 2021, reached approximately RMB 303.8 million, a year-on-year increase of 56.6%[13] - Gross profit increased by 62.4% to RMB 265.9 million in 2021, with gross margin rising to 87.5% from 84.4% in 2020, primarily due to increased sales of DCB products[49] - R&D costs increased by 69.2% to RMB 141.3 million in 2021, driven by the acquisition of a Shenzhen R&D center, increased employee costs, and higher investment in ongoing R&D projects[55] - Sales and distribution expenses rose by 80.4% to RMB 58.8 million in 2021, mainly due to employee stock ownership plan expenses and increased sales staff costs[54] - Other income increased by 147.8% to RMB 11.4 million in 2021, attributed to higher government subsidies and increased interest income from bank deposits[50] - Administrative expenses decreased by 19.4% to RMB 58.1 million in 2021, primarily due to reduced share-based compensation[57] - The company recorded a loss of RMB 8.8 million in other gains and losses in 2021, compared to a gain of RMB 0.7 million in 2020, mainly due to foreign exchange losses[51] - The fair value change of preferred shares resulted in a loss of RMB 33.5 million in 2021, compared to a gain of RMB 0.4 million in 2020[52] - Income tax expenses decreased by 7.8% to RMB 11.8 million in 2021, primarily due to additional tax deductions from increased R&D expenses[59] - Annual loss increased to RMB 79.077 million in 2021 from RMB 44.292 million in 2020[61] - Adjusted net profit for the year was RMB 42.390 million in 2021, up from RMB 17.534 million in 2020[61] - Cash and cash equivalents increased by 673.1% to RMB 1,137.2 million in 2021 from RMB 147.1 million in 2020[64] - Bank loans decreased by 70.0% to RMB 6.0 million in 2021 from RMB 20.0 million in 2020[65] - Capital expenditure for 2021 totaled RMB 21.9 million, allocated for property, plant, equipment, rental deposits, and intangible assets[68] - Net current assets increased by 721.5% to RMB 1,155.4 million in 2021 from a net current liability of RMB 185.9 million in 2020[66] - Capital-to-debt ratio improved to 8.3% in 2021 from -197.1% in 2020[65] - The net proceeds from the global offering and the full exercise of the over-allotment option amounted to approximately RMB 1,294.0 million, which will be used in accordance with the intended purposes disclosed in the prospectus[74] - As of December 31, 2021, the company had utilized RMB 152.619 million of the net proceeds, with RMB 1,141.341 million remaining unused[75] - The company made charitable donations totaling RMB 130,000 during the year ended December 31, 2021[143] - The company paid RMB 3,500 thousand for audit services to Deloitte Touche Tohmatsu during the fiscal year 2021[175] Product Development and Pipeline - The company's core products, Orchid® & Dhalia™, and AcoArt Tulip™ & Litos™, continue to dominate revenue, with sales expected to remain the primary revenue source in the short term[7] - The peripheral thrombus aspiration system, including AcoStream™, was launched in 2021, making the company the only Chinese enterprise with proprietary technology in this field[8] - The company is expanding its product pipeline, with over 30 products expected to be launched based on its four technology platforms (drug-coated technology, aspiration platform technology, polymer material technology, and radiofrequency ablation technology)[8] - BTK DCB (below-the-knee drug-coated balloon) was admitted to 288 hospitals and completed listing in 27 provinces and autonomous regions[10][13] - ATK DCB (above-the-knee drug-coated balloon) was admitted to 1,283 hospitals[10][13] - Three drug-coated balloon products were approved for commercialization in Brazil, bringing the total number of countries with commercialized products to 12[10][14] - Five products were sent for type testing, seven products were undergoing clinical trials, two products completed clinical trials, and two products were approved by the National Medical Products Administration[13] - The company registered ten additional patents in 2021[13] - The peripheral thrombus aspiration system (AcoStream™) was launched, making the company the only Chinese enterprise with original technology and a complete solution in this field[13] - The company has developed six new products, including peripheral IVL systems, peripheral coils, and coronary IVL systems, with rapid progress in product development[17][18] - The company's peripheral IVL system was designed and implemented within seven months, showcasing strong execution capabilities[17] - The company's product pipeline includes 28 products under development, with five already commercialized[19] - The company's core product, AcoArt Orchid® & Dhalia™, has been launched in 12 countries, including Germany, Italy, and Brazil, with no major adverse events reported[22] - AcoArt Orchid® & Dhalia™ achieved a 91.4% patency rate at six months and 66.1% at 12 months in a clinical trial for AVF stenosis treatment[22] - The company expects to receive NMPA approval for AcoArt Orchid® & Dhalia™ in the nephrology field by 2022 and in the neurology field by 2024[22] - AcoArt Orchid® & Dhalia™ generated revenue of approximately RMB 275.07 million in China and overseas for the year ended December 31, 2021[23] - AcoArt Tulip™ & Litos™ generated revenue of approximately RMB 24.09 million in China and overseas for the year ended December 31, 2021[24] - AcoArt Iris™ & Jasmin™ and AcoArt Lily™ & Rosmarin™ generated combined revenue of approximately RMB 4.58 million for the year ended December 31, 2021[27] - Peripheral aspiration system (AcoStream™) generated revenue of approximately RMB 35,400 for the year ended December 31, 2021[27] - The company has 14 pipeline products in vascular surgery, 10 in cardiology, 2 in nephrology, and 2 in neurology[25] - The company is expanding the indications of AcoArt Orchid® & Dhalia™ for the treatment of vasculogenic ED[25] - The company submitted an IDE application to the FDA for AcoArt Litos™ in January 2022 and is screening business partners for US clinical trials[24] - The company expects to obtain NMPA approval for peripheral support catheters in 2022[28] - The company expects to submit product registration for above-knee PTA balloons to the NMPA in 2022 and obtain approval in the same year[29] - The company expects to obtain NMPA approval for the radiofrequency ablation system in 2022[29] - Peripheral scoring balloon is in the preclinical research stage, expected to submit for NMPA registration in 2022 and obtain approval in 2023[31] - Second-generation peripheral aspiration system is under development, expected to obtain NMPA approval in 2023[31] - Peripheral IVL system is under development, expected to obtain NMPA approval in 2026[31] - Peripheral thrombectomy device is under development, expected to obtain NMPA approval in 2025[31] - Peripheral coil is under development, expected to obtain NMPA approval in 2024[31] - Carotid artery stent is under development, expected to obtain NMPA approval in 2025[31] - Coronary CTO antegrade microcatheter is under development, expected to obtain NMPA approval in 2023[32] - Coronary CTO re-entry balloon with a diameter of 0.8mm is under development, expected to obtain NMPA approval in 2023[33] - Coronary dual-lumen selective microcatheter is under development, expected to submit for NMPA registration in 2022 and obtain approval in 2023[33] - AcoArt Camellia™ for coronary small vessel disease is undergoing RCT, expected to obtain NMPA approval in 2024[33] - The company developed and launched China's first peripheral DCB product in 2016, leading the second similar product by approximately four years[94] - The second DCB product was designated as a "Breakthrough Device" by the FDA in 2019 and received NMPA approval in December 2020, becoming the first BTK DCB product globally approved based on multicenter randomized controlled clinical trial results[94] - The company has developed six new products, including peripheral IVL systems, peripheral coils, and coronary IVL systems, with rapid development progress[94] - The company's 2,400 square meter facility in Shenzhen obtained ISO13485 certification in 2021, enhancing manufacturing capabilities for balloon catheter tubing[94] - AcoArt Orchid® & DhaliaTM, a paclitaxel DCB, has been approved by the National Medical Products Administration (NMPA) and is available in 12 countries including Germany, Italy, and Brazil as of December 31, 2021[196] - AcoArt TulipTM & LitosTM, another paclitaxel DCB, received FDA "Breakthrough Device" designation in 2019 and NMPA approval in December 2020, making it the first BTK DCB product approved in China[197] - The company plans to expand its product offerings by leveraging synergies among its four core technologies and aims to increase sales of AcoArt Orchid® & DhaliaTM[198] - AcoArt LitosTM is undergoing clinical trial partner screening for the U.S. market, with plans to initiate relevant application procedures[197] - The company's DCB products are designed to address vascular diseases, with a focus on reducing restenosis and thrombosis risks compared to traditional PTA balloons and stents[195] - AcoArt Orchid® & DhaliaTM was the first peripheral DCB product launched in China, receiving CE certification in 2014 and NMPA approval in 2016[196] - The company aims to expand its geographic coverage and global strategic layout to become a global leader in the field[198] - AcoArt TulipTM & LitosTM is compatible with 0.018-inch (TulipTM) and 0.014-inch (LitosTM) guidewires, targeting chronic limb ischemia treatment[197] - The company holds multiple domestic and international core intellectual property rights, supporting its innovative medical device development[192] - AcoArt Orchid® & DhaliaTM is compatible with 0.035-inch (Orchid®) and 0.018-inch (DhaliaTM) guidewires, targeting lower extremity arterial disease (LEAD)[196] - The company's first product, AcoArt Orchid® & Dhalia™, launched in 2016, was China's first peripheral DCB product[199] - AcoArt Tulip™ & Litos™, launched in 2020, remains the world's first and only below-the-knee DCB product[199] - The company focuses on four major platform technologies and five therapeutic areas to expand its product pipeline[200] - The company aims to become a comprehensive vascular intervention technology platform company[200] - The company maintains a leading position in its niche market despite challenges such as localized COVID-19 outbreaks and economic downturns[200] - The company emphasizes strict quality control and a mature quality management system to ensure product safety[199] - The company prioritizes clinical needs, with R&D driven by unmet clinical demands[199] - The company is committed to green development and contributes to building a low-carbon society[200] - The company values talent development and has established a multi-level talent梯队 to enhance professional skills[199] - The company maintains close, mutually beneficial relationships with suppliers to ensure high-quality products and services[200] R&D and Innovation - The company established Acotec Technologies Limited in California, focusing on forward-looking and innovative product development[9][14] - Four global top medical experts joined the Scientific Advisory Committee to guide clinical research and product launches in the US and Europe[9][14] - The company's employee count reached approximately 400, with the R&D team growing to 86 members[16] - The company has obtained ISO 13485 certification for its 2,400 square meter facility in Shenzhen, enhancing its manufacturing capabilities[18] - The company has a strong internal R&D team of 86 members, led by experienced professionals including Ms. Li Weijia, Ms. Yaze Li, Mr. Ruijie Zhang, Mr. Lu Lizhong, and Mr. Scott Wilson[39] - The company owns 27 registered patents and has 13 pending patent applications as of December 31, 2021[39] - The company established a new R&D team in a 600-square-meter laboratory in Shenzhen, focusing on active medical devices[39] - The company set up Acotec Technologies Limited in California, USA, as its R&D center, led by Mr. Scott Wilson, who has over 25 years of experience in medical device development[39] - The company expanded its Scientific Advisory Board with four top doctors to guide global studies for FDA registration and new product development in peripheral intervention[41] - The company's main production facility in Beijing covers 6,000 square meters, and it expanded production capacity with a 2,400-square-meter facility in Shenzhen, achieving ISO 13485 certification[42] - The company has a comprehensive intellectual property portfolio, including 27 registered patents, 26 registered trademarks, and 13 pending patent applications as of December 31, 2021[44] - The company's clinical trials and product sales were not significantly impacted by COVID-19, with no confirmed or suspected cases reported among employees as of December 31, 2021[45] - The company's future growth heavily depends on the successful development and commercialization of its pipeline products[99] - The company's clinical product development involves a lengthy and costly process with uncertain outcomes[99] - The company has a total of 313,389,171 issued shares as of December 31, 2021[112] - Li Jing holds 55,291,087 shares, representing approximately 17.64% of the company's equity[112] - Silvio Rudolf Schaffner holds 4,272,065 shares, representing approximately 1.36% of the company's equity[112] - CA Medtech Investment (Cayman) Limited holds 158,614,642 shares, representing approximately 50.61% of the company's equity[115] - CPEChina Fund III, L.P. holds 161,877,642 shares, representing approximately 51.65% of the company's equity[115] - Cosmic Elite Holdings Limited holds 43,062,647 shares, representing approximately 13.74% of the company's equity[115] - The company's executive directors have service agreements with an initial term of three years from the listing date[109] - The company's non-executive directors have service agreements with an initial term of three years from the listing date[109] - The company's independent non-executive directors have appointment letters with a term of three years from the listing date[109] - The company confirms that all independent non-executive directors are independent as of the date of the annual report[110] - The company had a total of 313,389,171 shares issued as of December 31, 2021[116] - CPE Investment Wu Limited holds 3,263,000 shares of the company, with 85.61% owned by CPEChina Fund III and 14.39% by CPE Global Opportunities Fund[116] - Cosmic Elite, a subsidiary of Nexus Partners Group Limited, holds 43,062,647 shares, with 95.31% ownership by Nexus Partners Group Limited[116] - No warrants were issued by the company during the year ended December 31, 2021[119] - No significant legal proceedings or claims were pending or threatened against the company as of December 31, 2021[123] - The company has established a Remuneration Committee to review and establish transparent procedures for the remuneration policies of directors and senior management[125] - One senior management member received remuneration between HKD 1,000,001 and HKD 1,500,000, while two others received between HKD 8,500,001 and HKD 9,500,000 for the year ended December 31, 2021[126] - The Restricted Share Unit Plan was approved on January 8, 2021, with 12,228,440 ordinary shares issued to Sino Fame Ventures Limited[127] - No Restricted Share Units were granted, vested, canceled, or lapsed under the Restricted Share Unit Plan during the year ended December 31, 2021[127] - The Restricted Share Unit Plan is effective for ten years from its adoption date, with no further awards to be granted after the expiration[128] - The total number of shares available for issuance under the Restricted Share Unit Plan is 12,228,440 shares, held by the trustee nominee shareholder Sino Fame Ventures Limited[129] - The Restricted Share Unit Plan includes participants such as employees, officers, consultants, and other individuals or entities providing services to the company[129] - The Restricted Share Unit Plan has a vesting period, and if conditions are not met, the vesting date is postponed by one year, with unvested units automatically forfeited if conditions remain unmet[130] - The company adopted a Share Award Plan on December 31, 2021, managed by Hengtai Trust (Hong Kong) Limited, with awards granted in the form of shares or cash based on the actual sale price of the shares[131] - The Share Award Plan aims to recognize contributions and incentivize selected participants to remain with the company, promoting its continuous operation and development[132

Financial Performance - Revenue for the six months ended June 30, 2021, was RMB 140,195 thousand, representing a 106.0% increase compared to RMB 68,066 thousand for the same period in 2020[7] - Gross profit for the same period was RMB 123,677 thousand, up 118.6% from RMB 56,580 thousand year-over-year[7] - The company reported a loss before tax of RMB (6,590) thousand, compared to a profit of RMB 18,195 thousand in the previous year, indicating a significant shift in financial performance[7] - The net loss attributable to the owners of the company for the period was RMB (12,536) thousand, compared to a profit of RMB 17,308 thousand in the prior year[7] - Adjusted net profit for the period was RMB 37.966 million, a 120.0% increase compared to RMB 17.260 million for the same period in 2020[57] - The company reported a net cash inflow from operating activities of RMB 21,033,000 for the six months ended June 30, 2021, compared to RMB 15,931,000 for the same period in 2020, representing a year-over-year increase of approximately 32.9%[92] - The company experienced a decrease in cash and cash equivalents of RMB 123,231,000 for the six months ended June 30, 2021, compared to a decrease of RMB 2,373,000 in the same period of 2020[93] - The company’s total liabilities as of June 30, 2021, amounted to RMB 290,976,000, with net current liabilities of RMB 101,433,000[97] Product Development and Pipeline - The product pipeline includes 4 commercialized products and 24 products under development, all classified as Class III medical devices by the National Medical Products Administration[9] - The company is a pioneer in expanding the indications for DCB products, targeting various vascular diseases including peripheral artery disease (PAD) and coronary artery disease (CAD)[8] - The company also develops other therapeutic and surgical medical devices, such as thrombectomy devices and radiofrequency ablation systems[8] - The company is expanding its pipeline with 11 products in development across various medical fields[15] - The coronary CTO recanalization balloon, with a diameter of 0.8mm, is under development and is expected to be the smallest balloon on the market, with product registration submission planned for Q1 2022 and NMPA approval expected in Q3 2022[26] - AcoArt CamelliaTM, a paclitaxel DCB for treating small vessel disease, has recruited 46 patients as of August 3, 2021, with a target of completing recruitment of 230 patients by Q1 2022 and NMPA submission expected in Q1 2023[30] Market Presence and Expansion - The company aims to enhance its market presence and product offerings through continuous innovation and expansion strategies[8] - AcoArt Orchid® & DhaliaTM generated revenue of RMB 122.7 million in sales in China and overseas for the six months ended June 30, 2021[13] - As of August 3, 2021, AcoArt Orchid® & DhaliaTM was available in 1,056 hospitals in China for peripheral vascular intervention[12] - The company has launched AcoArt Orchid® in 12 other countries including Germany, Italy, and Spain as of August 3, 2021[12] - The company plans to continue expanding in both the Chinese and global markets, focusing on product development and growth through internal development, mergers, and acquisitions[67] Research and Development - Research and development costs for the six months ended June 30, 2021, were RMB 61.4 million, an increase of 327.9% from RMB 14.3 million for the same period in 2020, driven by acquisitions and increased employee costs[50] - The company has a strong internal R&D team of 62 members and holds 25 registered patents and 15 pending patent applications as of August 3, 2021[36] - The company plans to continue investing in research and development to enhance its product offerings and market position[87] Regulatory and Compliance - AcoArt Orchid® received CE marking in 2014 and regulatory approval from the National Medical Products Administration in 2016[12] - The company plans to submit a product registration application to the National Medical Products Administration by the end of 2021[12] - The company has adopted a corporate governance code and has complied with all applicable provisions since the listing date, with a commitment to maintaining high standards of corporate governance[70] Financial Position and Liabilities - Cash and cash equivalents as of June 30, 2021, were RMB 20.7 million, a decrease of 85.9% from RMB 147.1 million as of December 31, 2020, mainly due to operating expenses and dividend payments[60] - Total borrowings as of June 30, 2021, amounted to RMB 142.7 million, an increase of 613.7% from RMB 20.0 million as of December 31, 2020, primarily due to a loan of USD 19 million obtained from Silicon Valley Bank[61] - The capital to debt ratio as of June 30, 2021, decreased to -159.9% from -197.1% as of December 31, 2020[61] - The company’s total equity (deficit) as of June 30, 2021, was RMB (290,976) thousand, compared to RMB (281,009) thousand at the end of 2020[89] Shareholder Information - CA Medtech Investment (Cayman) Limited holds 50.61% of the company's shares, totaling 158,614,642 shares[77] - CPEChina Fund III, L.P. has a 51.65% stake in the company, with 161,877,642 shares[77] - Cosmic Elite Holdings Limited owns 13.63% of the company, amounting to 42,720,647 shares[77] - Morgan Stanley & Co. International plc holds 5.88% of the company's shares, totaling 18,455,000 shares[78] - The total number of shares issued by the company as of the listing date is 313,389,171 shares[78] Employee and Management - As of August 3, 2021, the company employed a total of 287 staff, primarily based in China[66] - Total employee costs increased to RMB 75,505,000, up from RMB 21,592,000 in the previous year, reflecting a rise of approximately 250%[1] - Total short-term employee benefits for key management personnel increased to RMB 5,109,000 for the six months ended June 30, 2021, up from RMB 3,913,000 in 2020, reflecting a 30.5% growth[147]