Employee Management and Welfare - As of December 31, 2022, the company employed 659 full-time employees, with a gender distribution of 277 males and 382 females[5] - The company provides various employee benefits, including paid annual leave, marriage leave, and maternity leave, along with a comprehensive compensation structure[41] - The company reported a focus on employee care, including equal opportunities, diversity, anti-discrimination, and employee training and development[85] - The company has established a training management program to enhance employees' professional skills, with a focus on self-driven learning and continuous improvement[40] Safety and Compliance - The company has implemented a series of safety measures in compliance with various laws and regulations, including the Occupational Disease Prevention Law and the Production Safety Law of the People's Republic of China[20] - The company reported a total of 92 workdays lost due to work-related injuries in the current year, with no fatalities recorded over the past three years[43] - The company is committed to providing a safe working environment and has policies in place to prevent occupational hazards[86] - The company has implemented strict information security and privacy policies to protect sensitive data[66] - The company has established strict compliance with various laws and regulations, including anti-money laundering and anti-corruption measures, with no reported incidents of fraud or bribery in the year[58] Environmental Management - The company has developed an energy-saving and emission reduction control plan to address greenhouse gas emissions from its operations[23] - The total greenhouse gas emissions (Scope 1 and 2) for the year were quantified at 1,129.47 tons of CO2 equivalent, an increase from 1,106.37 tons in 2021, representing a growth of approximately 2.1%[46] - The average greenhouse gas emissions per employee decreased significantly to 1.14 tons of CO2 equivalent, down from 2.64 tons in 2021, reflecting a reduction of approximately 56.8%[46] - The company has set up a waste management system to oversee the classification, disposal, and recycling of office waste[26] - The company generated 6,200 kilograms of non-hazardous waste, with a per capita waste generation of 9.41 kilograms, and successfully recycled 652 kilograms[49] - The company has identified climate change risks, categorizing acute physical risks as moderate and chronic physical risks as low[28] Governance and Stakeholder Engagement - The company has established effective communication channels with shareholders and investors to provide timely updates on its latest developments[3] - The company maintains close communication with stakeholders, including shareholders, employees, suppliers, and regulatory bodies[76] - The company has established an ESG supervisory committee to oversee and promote sustainability initiatives[75] - The company integrates social responsibility into its business development strategy and human resource management[73] Product Development and Market Position - The company focuses on diabetes management, providing treatment and monitoring medical devices, addressing a significant unmet clinical need in the market[109] - Revenue growth is primarily driven by the sales increase of the product Equil; failure to achieve expected sales growth could significantly adversely affect the business and financial performance[149] - The company faces intense competition in the industry, with many competitors having greater resources, which could negatively impact sales and operational performance[148] - Clinical trial recruitment challenges may delay clinical development activities, affecting the ability to advance in-development products[151] Financial Performance and Funding - The company’s financial summary includes details on bank loans and other borrowings, reflecting its financial position as of December 31, 2022[92] - The company has no bank loans or other borrowings as of December 31, 2022[116] - The company has not declared or paid any dividends for the year ending December 31, 2022[112] - The company raised approximately HKD 1,875.53 million (equivalent to RMB 1,533.49 million) from its global offering and partial exercise of the over-allotment option after deducting underwriting fees and estimated expenses[136] Research and Development - The company has filed 34 new patents and pending patent applications this year, totaling 116 patents as of December 31, 2022[69] - The company’s research and commercialization of products are subject to strict regulations; failure to obtain necessary regulatory approvals could severely hinder revenue generation capabilities[155] - The development of medical devices involves high upfront capital expenditures and significant uncertainty regarding regulatory approval and market acceptance[125] Community and Social Responsibility - The company is focused on community investment and ensuring that its business activities consider community interests[89] - The company has implemented measures to avoid child labor and forced labor, ensuring compliance with relevant laws and regulations[87] Quality Management - The company has established a comprehensive quality management system in compliance with relevant medical device regulations to ensure product quality and safety[174] - The company has a systematic internal quality audit plan to review and improve its quality management system regularly[174] - The company emphasizes the importance of training and management in maintaining a safe and hygienic working environment[178] Market Expansion and Strategic Partnerships - The company is focused on expanding its global market presence through strategic partnerships and participation in academic conferences[158] - The company has utilized 31% of the IPO proceeds for core product funding, amounting to HKD 581.42 million (RMB 475.38 million) as of December 31, 2021[158]

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 就 因 本 公 告 全 部 或 任 何 部 分 內 容 而 產 生 或 因 倚 賴 該 等 內 容 而 引 致 的 任 何 損 失 承 擔 任 何 責 任。 微 泰 醫 療 器 械（杭 州）股 份 有 限 公 司（「本 公 司」）董 事 會（「董 事 會」）欣 然 宣 佈 本 公 司 及 其 附 屬 公 司（「本 集 團」、「我 們」或「我 們 的」）截 至2022年12月31日 止 年 度（「報 告 期 間」）的 經 審 核 合 併 年 度 業 績，連 同 截 至2021年12月31日 止 年 度 的 比 較 數 字。 – 1 – 合 併 損 益 表 截 至2022年12月31日 止 年 度 – 4 – 年 內 虧 損 (35,043) (48,153) 於 後 續 期 間 可 能 重 新 分 類 至 損 益 的 於 後 續 期 間 可 能 重 新 分 類 至 損 益 的 年 ...

Financial Performance - For the six months ended June 30, 2022, the company reported revenue of RMB 71.8 million, a 20.9% increase compared to RMB 59.4 million for the same period in 2021[5]. - Gross profit for the same period was RMB 31.8 million, showing a slight increase of 0.9% from RMB 31.5 million year-on-year[5]. - The net loss narrowed to RMB 7.9 million, a 58.3% improvement from a net loss of RMB 19.1 million in the previous year[5]. - The company's revenue for the six months ended June 30, 2022, was RMB 718.24 million, an increase of 20.9% compared to RMB 594.09 million for the same period in 2021[27]. - The company reported losses of RMB 19.1 million and RMB 7.9 million for the six months ended June 30, 2021, and June 30, 2022, respectively[37]. - The company reported a pre-tax loss of RMB 7,942,000 for the six months ended June 30, 2022, compared to a loss of RMB 19,056,000 in the same period of 2021, indicating an improvement of approximately 58.3%[102]. - The company's basic and diluted loss per share improved to RMB (0.02) from RMB (0.05) year-on-year[96]. - Other income and gains rose significantly by 271.7% from RMB 10.6 million to RMB 39.4 million, primarily due to increased bank deposit interest and foreign exchange gains[30]. Product Development and Innovation - The company achieved sales revenue of RMB 12.9 million from the AiDEX G7 continuous glucose monitoring system in the first half of 2022[8]. - The new generation continuous glucose monitoring system AiDEX X has completed registration inspection and is expected to finish clinical trials by the end of 2022[7]. - The company is developing AiDEX X, a new non-calibration continuous glucose monitoring system, expected to complete clinical trials by the end of 2022 and submit registration applications in early 2023[16]. - The company is conducting a critical clinical trial for Equil for children and adolescents, with over 80% of participants enrolled as of June 30, 2022[12]. - The company aims to enhance diabetes management through innovative monitoring and treatment methods, focusing on a user-centered approach and clinical data-driven marketing strategies[9]. - The company has been focusing on research and development in diabetes management medical devices and consumables, aligning with its core business strategy[105]. - The company has successfully expanded into over ten European countries and several countries in the Middle East and North Africa, with plans to enter more European markets in the second half of 2022[49]. Market Expansion and Strategy - The company is expanding the clinical research of Equil to include children and adolescents, expected to complete by Q3 2022[7]. - The company is expanding its marketing network and developing a cloud-based diabetes management platform to provide personalized solutions[9]. - The strategic goal includes increasing brand awareness of core products and expanding international market presence[9]. - The company plans to expand its sales, marketing, and customer service teams in the second half of 2022 to promote its products and services in hospitals and individual user markets[45]. - The company is expanding its market presence in Southeast Asia, targeting a 20% market share by the end of 2023[142]. - A strategic acquisition of a local competitor is in progress, which is anticipated to increase the company's market share by 10%[142]. Financial Management and Governance - The company has no interest-bearing bank or other borrowings, with a debt-to-asset ratio of 3.3%[38]. - The company decided not to declare an interim dividend for the six months ended June 30, 2022[61]. - The audit committee reviewed the unaudited interim financial information for the six months ended June 30, 2022, confirming compliance with accounting standards and regulations[60]. - The company is committed to high standards of corporate governance, having adopted the relevant code provisions, with a current exception regarding the separation of the roles of Chairman and CEO[57]. - The company has a total of 425,742,600 issued shares, including 65,742,600 H shares, 286,473,574 domestic shares, and 73,526,426 unlisted foreign shares as of June 30, 2022[76]. Research and Development Expenses - Research and development costs accounted for 34.2% of sales revenue, an increase compared to the same period last year[7]. - Research and development expenses grew by 68.5% from RMB 14.6 million to RMB 24.6 million, driven by increased employee costs and experimental materials[35]. - The company invested RMB 20 million in R&D for new technologies aimed at improving product quality and compliance with GMP standards[141]. Operational Challenges - The ongoing COVID-19 pandemic has negatively impacted market expansion and sales growth, particularly in cities affected by outbreaks[53]. - The company is closely monitoring the impact of COVID-19 on its operations and plans to implement necessary measures to mitigate adverse effects[54]. - The company experienced a substantial increase in inventory, which rose by RMB 27,730,000 compared to an increase of RMB 5,338,000 in the prior year, reflecting a change in inventory management strategy[102]. Shareholder Information - Dr. Zheng holds 88,278,594 domestic shares, representing approximately 30.82% of the relevant shares and 20.74% of the total equity[70]. - The major shareholder Hangzhou Yantai Investment Partnership holds 19,031,297 domestic shares, accounting for approximately 6.64% of the relevant shares and 4.47% of the total equity[74]. - The company has a controlled entity interest of 34,729,562 domestic shares held by Dr. Zheng, representing approximately 12.12% of the relevant shares[70]. - The company anticipates gradual utilization of the remaining net proceeds based on actual business needs[68].

Financial Performance - In 2021, the company achieved a revenue of RMB 151,404 thousand, representing a 100.9% increase from RMB 75,277 thousand in 2020[6]. - The gross profit for 2021 was RMB 70,883 thousand, up from RMB 36,544 thousand in 2020, indicating a gross margin improvement[6]. - The net loss for 2021 was RMB (48,153) thousand, a significant reduction from RMB (121,250) thousand in 2020, showing improved financial performance[6]. - The company's total revenue for the year ended December 31, 2021, was RMB 151.40 million, an increase of 101.1% from RMB 75.28 million for the year ended December 31, 2020[23]. - Sales revenue for the core product, Equil insulin pump system, reached RMB 731 million, a 110.7% increase from RMB 347 million in the previous year[11]. - The company's cost of sales for the year ended December 31, 2021, was RMB 80.52 million, a 107.9% increase from RMB 38.73 million for the year ended December 31, 2020[24]. - Gross profit increased by 94.0% from RMB 36.54 million for the year ended December 31, 2020, to RMB 70.88 million for the year ended December 31, 2021, with a gross margin decrease from 48.5% to 46.8%[25]. - Other income and gains rose by 5.1% from RMB 27.66 million for the year ended December 31, 2020, to RMB 29.06 million for the year ended December 31, 2021, primarily due to increased interest income[26]. - The total liabilities were reported at RMB 82,478 million, indicating a strong equity position with total equity matching net assets[7]. - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB, representing a year-over-year growth of 25%[1]. - The company provided a positive outlook for the next fiscal year, projecting a revenue growth of 20% to 1.8 billion RMB[3]. Product Development and Innovation - The company successfully launched the first domestically produced non-calibration continuous glucose monitoring system, approved by the National Medical Products Administration[4]. - Ongoing development of new products, including the next-generation patch insulin pump and closed-loop artificial pancreas, is expected to enhance the company's market position[4]. - The second-generation insulin pump system is under development, featuring a smaller size and improved waterproof capabilities, with a submission for type testing completed by the end of 2021[13]. - The AiDEX G7 continuous glucose monitoring system is the second commercialized system globally, with clinical trials for pediatric use expected to be completed in 2022[14]. - The company plans to develop a cloud-based diabetes management platform to enhance clinical benefits and reduce costs for diabetes patients globally[9]. - The closed-loop artificial pancreas system, which includes the insulin pump and continuous glucose monitoring system, is expected to begin clinical work in the second half of 2022[16]. - The company has developed and commercialized 15 types of blood glucose meters and 7 types of test strips in China since its establishment[18]. - The Exactive Pro system, which measures blood glucose, ketones, and uric acid, has completed registration for hospital market products, with potential to be the first integrated product in China[18]. - The company plans to develop and commercialize a closed-loop artificial pancreas system for adult patients, with future expansion to children and adolescents[17]. - The company aims to continue investing in product development and clinical registration for existing pipeline products, including expanding indications for children and adolescents for the Equil and continuous glucose monitoring systems[47]. Market Expansion and Strategy - The company plans to expand sales channels in hospitals, retail, e-commerce, and foreign trade to leverage the broad applicability of its products[4]. - The company aims to expand its marketing network and brand awareness for core products while exploring international market opportunities[9]. - The company aims to become a leading international brand in diabetes treatment and monitoring devices, focusing on developed markets such as Europe and North America, benefiting from higher healthcare costs and insurance coverage in these regions[45]. - The Equil brand has successfully entered over ten European countries, with sales in Italy and the Netherlands, and a 510(k) registration application submitted to the FDA in 2021, expected to receive approval by the end of 2022[46]. - The company plans to expand its sales, marketing, and customer service teams in 2022 to promote its products and services in hospitals and among individual users[42]. - The company is expanding its market presence in Southeast Asia, targeting a 10% market share within the next two years[5]. - The company aims to improve internal production and quality systems while expanding new production sites and automating production lines to meet growing market demand[5]. - The company is focusing on the development of innovative medical devices, with an R&D budget increase of 30% compared to the previous year[56]. - Future outlook indicates a projected revenue growth of 15% for the next fiscal year, driven by new product launches and market expansion strategies[55]. Corporate Governance and Management - The company emphasizes the importance of attracting talent to enhance management efficiency and support rapid growth[5]. - The financial management team, led by CFO Liu Xiu, has over 17 years of experience and aims to improve financial transparency and investor relations[58]. - The company has established partnerships with leading healthcare institutions to accelerate product development and market entry[59]. - The supervisory board consists of three members, including two shareholder supervisors and one employee supervisor, elected for a term of three years[70]. - The company has a dedicated team with over 20 years of experience in the pharmaceutical and medical device industry, led by Vice President Lan Yi[74]. - The company has adopted the standards set out in the Listing Rules Appendix 10 regarding securities trading by directors, ensuring compliance from all directors and employees[80]. - The board consists of ten members, including four executive directors, two non-executive directors, and four independent non-executive directors[81]. - The company has appointed two joint company secretaries to enhance compliance and governance practices[76]. - The company has established service contracts with all directors, with a term of three years, subject to shareholder approval for reappointment[88]. - The board will continue to review the separation of the roles of chairman and CEO at an appropriate time[85]. Risk Management and Compliance - The company faces significant operational risks, including changes in the regulatory environment of the medical device market in China and globally, as well as competition with other medical device companies[108]. - The company has implemented a series of risk management policies to continuously identify, assess, and monitor key risks related to its strategic objectives[109]. - The board of directors is responsible for establishing and reviewing the effectiveness of the internal control system, which includes various measures and procedures across business operations[111]. - The company has a comprehensive financial policy detailing capital usage functions and internal control measures, including liquidity management and capital plan execution monitoring[113]. - The company has a strict anti-corruption policy for sales and marketing activities, requiring distributors to provide written commitments to comply with the company's standards[111]. - The company has established internal regulations for anti-fraud, anti-money laundering, and conflict of interest management, ensuring compliance and ethical conduct among employees[145]. - The company conducts annual assessments of money laundering risks and implements measures to verify customer identities and transaction purposes[145]. - The company has established various channels for whistleblowers to report suspicious activities, ensuring confidentiality and protection for those who report[147]. Environmental, Social, and Governance (ESG) - The company published its first ESG report, focusing on its performance from January 1, 2021, to December 31, 2021[133]. - The report includes all key performance indicators (KPIs) required by the Hong Kong Stock Exchange guidelines, ensuring transparency and consistency in disclosures[132]. - The board of directors is responsible for the company's ESG strategy and reporting, overseeing the implementation of ESG initiatives[138]. - The company identified 23 material ESG issues based on industry trends and regulatory requirements, prioritizing them for disclosure[142]. - High importance issues identified include supply chain management, information security, product quality and safety, and innovation in research and development[143]. - The company emphasizes the integration of social responsibility into its business development strategy and human resource management[137]. - The ESG supervisory committee has been established to enhance governance and oversight of ESG matters[139]. - The report highlights the company's commitment to balancing economic and social benefits in its operations[137]. - The company encourages stakeholder feedback on the ESG report, providing a dedicated email for communication[136]. Employee and Workplace Practices - The company emphasizes employee rights and equality, adhering to local labor laws and creating a fair work environment[159]. - The company has a systematic approach to managing and protecting intellectual property rights, ensuring no infringement occurs[157]. - The company has implemented a training management program and established a 2021 training plan to enhance employees' professional skills, including various training categories such as management training and qualification training[162]. - The company provided safety-related training for all employees, including new employee orientation and specialized training for high-risk positions[166]. - The total number of workdays lost due to work-related injuries in the year was 162, with no fatalities reported over the past three years[168]. - The company has zero reported work-related fatalities and 162 days lost due to work injuries[180]. - Employee turnover rate is 17.87% for production staff and 16.76% for non-production staff[178]. - Employee turnover rate by gender: 22.16% for females and 11.84% for males[180]. - Employee turnover rate by age group: 13.60% for under 30, 20.30% for ages 30-50, and 0.69% for over 50[180]. - The company has established policies to prevent child labor and forced labor, ensuring compliance with relevant laws[186]. Community Engagement and Social Responsibility - The company donated RMB 550,000.00 to social causes during the year[175]. - Community investment policies are in place to ensure that business activities consider community interests[188]. - The company is committed to sustainable development through collaboration with various stakeholders[200]. - The company recognizes the importance of maintaining strong relationships with stakeholders, including employees, healthcare professionals, patients, customers, suppliers, and business partners[200].