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

Acotec Scientific Holdings Limited 先瑞達醫療科技控股有限公司 （於開曼群島註冊成立的有限公司） 股份代號： 6669 2021中期報告 目 錄 | --- | --- | |------------------------------|-------| | | | | | | | | | | 公司資料 財務概要 | 2 4 | | 管理層討論及分析 | 5 | | 其他資料 | 24 | | 簡明綜合財務報表審閱報告 | 29 | | 簡明綜合損益及其他全面收益表 | 31 | | 簡明綜合財務狀況表 | 32 | | 簡明綜合權益變動表 | 34 | | 簡明綜合現金流量表 | 36 | | 簡明綜合財務報表附註 | 38 | | 釋義 | 58 | 公司資料 | --- | --- | |------------------------------------------------------|---------------------------------------------------------| | | | | 董事會 | 主要往來銀行 | | 執行董事 ...