康灃生物科技（上海）股份有限公司 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依賴 該等內容而引致的任何損失承擔任何責任。 Cryofocus Medtech (Shanghai) Co., Ltd. 本公司欣然宣布，於2025年3月6日，本集團的惡性狹窄冷凍消融系統（「惡性狹窄 冷凍消融系統」），本集團的呼吸介入產品之一，由冷凍治療設備及氣道冷凍消融 導管組成，已獲得國家藥品監督管理局（「國家藥監局」）授出的批文。 惡性狹窄冷凍消融系統為用於消融惡性氣道腫瘤組織、減少氣道再狹窄頻次的自 主研發冷凍消融系統。在手術過程中，惡性狹窄冷凍消融系統利用冷凍消融系統 產生的超低溫消融氣管腔內及腔壁的腫瘤細胞，然後通過復溫進一步破壞腫瘤細 胞。冷凍消融球囊能在較大範圍內對惡性腫瘤進行更徹底的消融，並推遲再狹窄 的時間。 本公司無法保證惡性狹窄冷凍消融系統的未來前景。本公司股東及潛在投資者於 買賣本公司證券時務請審慎行事。 承董事會命 康灃生物科技（上海）股份有限公司 董事會主席 李克儉先生 香港，202 ...

茲提述康灃生物科技（上海）股份有限公司（「本公司」）日期為2024年12月31日的 公告，內容有關重續現有總租賃協議（「該公告」）。除另有界定者外，本公告所用 詞彙與該公告所界定者具有相同涵義。 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依賴 該等內容而引致的任何損失承擔任何責任。 Cryofocus Medtech (Shanghai) Co., Ltd. 康灃生物科技（上海）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6922） 有關重續現有總租賃協議之持續關連交易的補充公告 董事會謹此向股東及本公司潛在投資者提供有關定價依據的進一步資料。誠如該 公告所披露，本集團於經續期總租賃協議項下訂立的租賃租金將由本公司與寧波 麟灃基於多項因素（包括但不限於鄰近地區類似物業的現行市場租金、租賃面積 及租賃期限）經公平磋商釐定。尤其是，本公司財務部將追蹤，並參考，位於將 出租之物業的鄰近地區且具有相近規格、用途、面積及性質的可資比較物業的現 行市場租金（包括位於麟灃醫療科技 ...

Cryofocus Medtech (Shanghai) Co., Ltd. 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依賴該等內容而引致的任何損失承擔任何責任。 康灃生物科技（上海）股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6922） 持續關連交易 重續現有總租賃協議 背 景 茲提述本公司日期為2022年12月16日 內 容 有 關 現 有 總 租 賃 協 議 的 招 股 章 程。 根 據 現 有 總 租 賃 協 議，本 集 團 已 自 寧 波 麟 灃 租 賃 於 麟 灃 醫 療 科 技 產 業 園（位 於中國寧波市杭州灣新區濱海四路777號）的 物 業，用 作 工 廠 及 員 工 宿 舍 用 途，而 現 有 總 租 賃 協 議 將 於2024年12月31日 止 屆 滿。 董 事 會 謹 此 宣 佈，於2024年12月31日，本 公 司（為 及 代 表 其 本 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 19,475,000, an increase of 3% from RMB 18,914,000 in the same period of 2023[6]. - Gross profit for the same period was RMB 15,281,000, up from RMB 14,638,000, reflecting a gross margin improvement[6]. - The company reported a net loss of RMB (55,953,000) for the first half of 2024, compared to a loss of RMB (47,428,000) in the prior year[6]. - Revenue increased from RMB 189 million for the six months ended June 30, 2023, to RMB 195 million for the six months ended June 30, 2024, representing a growth of 3.0%[34]. - Gross profit rose from RMB 146 million to RMB 153 million, with the gross margin improving from 77.4% to 78.5% due to higher sales of high-margin products[35]. - The company incurred a loss before tax of RMB 55,953 thousand, which is a decline from the loss of RMB 47,428 thousand reported in the previous year, reflecting an increase in losses of approximately 17.9%[79]. - The company reported a total of 125,013,402 non-listed shares and 114,096,598 H shares as of June 30, 2024[71]. - The basic and diluted loss per share for the period was RMB 0.22, compared to RMB 0.18 in the same period of 2023[79]. Research and Development - Research and development expenses increased to RMB (37,222,000) from RMB (34,330,000), indicating a focus on innovation despite losses[6]. - The company has established a product development team consisting of 90 internal R&D staff and 36 clinical operation team members as of June 30, 2024[31]. - The company holds 152 patents and has 53 patent applications in China and overseas as of June 30, 2024, to protect its technologies[31]. - Research and development expenses for the first half of 2024 were RMB 37,222 thousand, compared to RMB 34,330 thousand in the same period of 2023, showing an increase of approximately 8.5%[79]. Product Development and Approvals - The cardiac cryoablation system received production quality management standard approval in January 2024, marking a significant milestone[7]. - The company obtained market approval for the cryoadhesion treatment system in January 2024, following prior approvals for related equipment[7]. - The benign stricture cryoablation system entered confirmatory clinical trials in January 2024, indicating progress in product development[7]. - The Cryofocus cryoablation system is designed for hypertension treatment and is expected to receive regulatory approval by the second half of 2025[12]. - The chronic obstructive pulmonary disease cryo-spray treatment system entered confirmatory clinical trials in March 2023, with expected regulatory submission in the second half of 2025[14]. - The malignant stenosis cryoablation system's registration application was submitted by June 30, 2024, with anticipated approval in the first half of 2025[16]. - The benign stenosis cryoablation system entered confirmatory clinical trials in January 2024, with expected regulatory submission in Q4 2024[17]. - The asthma cryoablation system is currently in confirmatory clinical trials, with expected regulatory submission in the second half of 2025[15]. - The pulmonary hypertension cryoablation system is in preclinical research, with expected regulatory approval by the second half of 2027[13]. - The anti-reflux system is expected to be commercialized in the first half of 2025[11]. - The company has a diverse pipeline of cryoablation systems targeting various medical conditions, indicating a strong focus on innovation and market expansion[11]. Financial Position and Cash Flow - Cash and cash equivalents decreased from RMB 103.5 million as of December 31, 2023, to RMB 69.6 million as of June 30, 2024, a reduction of RMB 33.9 million, or 32.8%[45]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 50.4 million, primarily due to significant R&D expenditures[45]. - The current ratio decreased from 4.9 as of December 31, 2023, to 2.5 as of June 30, 2024[49]. - The debt-to-asset ratio increased from 18.5% as of December 31, 2023, to 31.7% as of June 30, 2024[49]. - The company reported a decrease in cash and cash equivalents to RMB 69,563,000 as of June 30, 2024, down from RMB 159,014,000 at the end of the previous year, representing a decline of approximately 56.3%[86]. - The company recorded a net cash outflow from investing activities of RMB 1,419,000 for the first half of 2024, compared to RMB 1,812,000 in the same period of 2023[86]. Shareholder Information - As of June 30, 2024, Mr. Zhu holds 9,721,236 non-listed shares, representing approximately 4.07% of the total issued share capital[64]. - Mr. Lu holds 91,369,084 non-listed shares, representing approximately 38.21% of the total issued share capital[64]. - The total number of issued shares as of June 30, 2024, is 239,110,000 shares[65]. - The company has a significant concentration of ownership, with major shareholders holding over 73% of the total issued share capital[68]. - The ownership structure indicates potential influence on corporate governance and strategic decisions due to concentrated holdings[66]. - The report highlights the importance of shareholder agreements in maintaining control and decision-making processes within the company[66]. Operational Highlights - A distribution agreement was signed in July 2024 with Boston Scientific International Medical Trading (Shanghai) Co., Ltd. for respiratory intervention products in mainland China[7]. - The company has commercialized eight products as of June 30, 2024, with a comprehensive product pipeline focusing on vascular intervention and NOTES[9]. - The company aims to establish itself as a global leader in innovative medical technology within the minimally invasive cryoablation treatment sector[8]. - The company aims to expand its global business selectively while focusing on the commercialization of its pipeline products[33].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 19,475,000, an increase of 3% from RMB 18,914,000 in the same period of 2023[2] - Gross profit for the same period was RMB 15,281,000, up from RMB 14,638,000, reflecting a gross margin improvement[2] - The net loss for the six months ended June 30, 2024, was RMB (55,953,000), compared to a loss of RMB (47,428,000) in the prior year, representing a 18% increase in losses[2] - Revenue from the sale of medical devices and consumables reached RMB 19,475,000 in the six months ended June 30, 2024, compared to RMB 18,914,000 in the same period of 2023, representing an increase of approximately 2.96%[19] - Other income decreased to RMB 2,122,000 for the six months ended June 30, 2024, down from RMB 3,750,000 in the same period of 2023, reflecting a decline of approximately 43.5%[21] - The group reported a pre-tax loss of RMB 34,330,000 attributed to research and development expenses during the six months ended June 30, 2024[22] - The group recognized a net foreign exchange loss of RMB 3,179,000 for the six months ended June 30, 2023[22] - The company reported a loss attributable to ordinary equity holders of RMB 52,171,000 for the six months ended June 30, 2024, compared to a loss of RMB 43,402,000 for the same period in 2023, representing an increase in loss of approximately 20%[28] - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB (0.22), compared to RMB (0.18) for the same period in 2023, indicating a deterioration in earnings per share[28] - The company has not declared or paid any dividends for the six months ended June 30, 2024, consistent with the previous year[26] Research and Development - Research and development expenses increased to RMB (37,222,000) from RMB (34,330,000), indicating a focus on innovation[2] - The group’s employee benefits expenses, including salaries and wages, amounted to RMB 29,414,000 for the six months ended June 30, 2023[22] - The company has established a product development team consisting of 90 internal R&D staff and 36 clinical operation staff[53] - The company holds 152 patents and has 53 patent applications as of June 30, 2024, to protect its core technologies[54] - The company aims to become a global platform for minimally invasive cryo-interventional medical devices, focusing on rapid clinical development and commercialization of its pipeline products[56] Product Development and Approvals - The company received market approval for its cryo-adhesion treatment system in January 2024, following previous approvals for related products[2][3] - The benign stricture cryoablation system entered the confirmatory clinical trial phase in January 2024[3] - The company submitted registration applications for its malignant stricture cryoablation system and gastroesophageal reflux system[4] - The Cryofocus cryoablation system is designed for hypertension treatment and is expected to receive regulatory approval from the National Medical Products Administration (NMPA) in the second half of 2025[35] - The cardiac cryoablation system received NMPA approval in December 2023, following clinical trials initiated in October 2019[34] - The chronic obstructive pulmonary disease (COPD) cryo-spray treatment system entered confirmatory clinical trials in March 2023, with expected NMPA submission in the second half of 2025 and approval anticipated in the second half of 2026[36] - The asthma cryoablation system is currently in confirmatory clinical trials, with NMPA submission expected in the second half of 2025 and approval anticipated in the second half of 2026[37] - The pulmonary hypertension cryoablation system is in preclinical research, with expected NMPA approval in the second half of 2027[35] - The anti-reflux system is expected to be commercialized in the first half of 2025[34] - The malignant stenosis cryoablation system is designed to treat malignant airway tumors and reduce the frequency of airway re-stenosis[37] - The company has submitted registration applications for several products, indicating a strong pipeline for future growth and market expansion[34] Financial Position - As of June 30, 2024, total non-current assets were valued at RMB 67,944,000, an increase from RMB 62,906,000 at the end of 2023[9] - Current assets decreased to RMB 116,701,000 from RMB 149,915,000, primarily due to a reduction in cash and cash equivalents[9] - Total equity as of June 30, 2024, was RMB 126,028,000, down from RMB 173,460,000 at the end of 2023[12] - Cash and cash equivalents decreased from RMB 1,035 million as of December 31, 2023, to RMB 696 million as of June 30, 2024, a reduction of RMB 339 million or 32.8%[70] - Total debt as of June 30, 2024, was RMB 17,697,000, up from RMB 11,011,000 as of December 31, 2023, representing an increase of approximately 60.5%[73] - The current ratio decreased to 2.5 as of June 30, 2024, from 4.9 as of December 31, 2023, while the debt-to-asset ratio increased to 31.7% from 18.5%[74] Governance and Corporate Structure - The board of directors includes executive directors Mr. Li Kejian, Mr. Zhu Jun, and Mr. Liu Wei, along with non-executive directors Mr. Lv Shiwen and Mr. Zhao Chunsheng, and independent non-executive directors Dr. Gao Dayong, Mr. Liang Xianzhi, Dr. Qin Zheng, and Dr. Hu Henan[93] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has reviewed and confirmed that the interim financial results for the six months ending June 30, 2024, comply with relevant accounting standards and regulations[87] - The board composition reflects a mix of executive and independent directors, which may enhance governance and strategic decision-making[93] - The presence of multiple independent directors may indicate a commitment to transparency and accountability in corporate governance[93] - The emphasis on board diversity may contribute to a broader range of insights and strategies for market expansion[93] Market and Strategic Outlook - The company is focused on biotechnology, suggesting potential developments in health-related products and technologies[93] - The company believes its competitive advantages and product pipeline create high barriers to entry for competitors in the market[31] - The company is likely to discuss future outlook and performance guidance in upcoming communications[93] - The announcement suggests ongoing engagement with stakeholders regarding company performance and strategic direction[93] - The date of the announcement indicates that the company is actively communicating with investors and the market[93]

Financial Performance - In 2023, the company's revenue increased by 50.8% year-on-year, reaching RMB 40,950,000[8] - Gross profit for 2023 was RMB 31,052,000, compared to RMB 19,362,000 in 2022, reflecting a significant improvement[8] - The company reported a net loss of RMB 105,746,000 for 2023, an improvement from a loss of RMB 118,316,000 in 2022[8] - Cash and cash equivalents decreased to RMB 103,402,000 in 2023 from RMB 226,422,000 in 2022[8] - The total equity of the company was RMB 173,460,000 in 2023, down from RMB 259,389,000 in 2022[10] - Revenue increased from RMB 27.1 million for the year ended December 31, 2022, to RMB 41.0 million for the year ended December 31, 2023, representing a growth of 50.8% driven by increased sales of the bladder cryoablation system, lung nodule localization needle, and endoscopic stapler[43] - Gross profit rose from RMB 19.4 million for the year ended December 31, 2022, to RMB 31.1 million for the year ended December 31, 2023, with the overall gross margin increasing from 71.3% to 75.8% due to higher revenue from the lung nodule localization needle and endoscopic stapler[45] Research and Development - R&D expenses increased from RMB 599 million in 2022 to RMB 761 million in 2023, a growth of RMB 162 million or 27.0%[49] - The company has established a product development team consisting of 99 internal R&D staff and 38 clinical operation staff as of December 31, 2023[40] - The company has a comprehensive intellectual property portfolio with 147 patents and 46 patent applications as of December 31, 2023[40] - The company aims to expand its product portfolio based on its cryoablation technology platform and selectively expand its global business[42] - The company has commercialized multiple non-freezing ablation products, including the lung nodule localization needle, endoscopic stapler, and single-port multi-channel laparoscopic surgical access system, with no significant adverse events reported since regulatory approvals[39] Product Development and Approval - The company has developed a comprehensive product portfolio including 14 cryotherapy products and 9 non-cryotherapy products, with 8 products already commercialized[16] - The cardiac cryoablation system is expected to receive approval from the National Medical Products Administration (NMPA) in December 2023, with production quality management review completed in January 2024[19] - The Cryofocus cryoablation system, targeting hypertension, is anticipated to gain NMPA approval in the second half of 2025[20] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected NMPA approval in the second half of 2027[21] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with registration documents expected to be submitted to NMPA in the second half of 2025[22] - The asthma cryoablation system entered confirmatory clinical trials in March 2023, with product registration submission expected in the second half of 2025 and approval anticipated in the second half of 2026[23] - The malignant stenosis cryoablation system is currently in confirmatory clinical trials, with patient recruitment completed; product registration submission is expected in Q2 2024 and approval in the first half of 2025[24] - The benign stenosis cryoablation system entered confirmatory clinical trials in January 2024, with product registration submission expected in Q4 2024 and approval anticipated in the first half of 2026[25] - The lung nodule cryoablation system began feasibility clinical trials in August 2023, with product registration submission expected in the second half of 2026 and approval anticipated in the second half of 2027[27] - The cough cryo-spray treatment system is currently in feasibility clinical trials, with product registration submission expected in the first half of 2025 and approval anticipated in the second half of 2026[28] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with product registration submission expected in the second half of 2025 and approval anticipated in the second half of 2026[29] - The frozen adhesion treatment system received regulatory approval in January 2024, with the system designed for biopsy, stenosis recanalization, and foreign body removal[30] - The bladder cryoablation system was approved by the National Medical Products Administration in June 2022 and commercialized in China in December 2022[31] - The gastric cryoablation system is currently in feasibility clinical trials, with product registration submission expected in the second half of 2025 and approval anticipated in the second half of 2026[32] - The esophageal cryo-spray treatment system is in feasibility clinical trials, with product registration submission expected in the second half of 2025 and approval anticipated in the first half of 2027[33] Management and Governance - The company has expanded its management team with experienced professionals from various medical technology firms, enhancing its strategic decision-making capabilities[80] - The board consists of three executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balance of power and authority[100] - The company has adopted the principles and code provisions of the corporate governance code to regulate its governance practices[97] - The Chief Executive Officer and the Chairman roles are held by different individuals, ensuring a separation of powers[98] - The board includes members with significant experience in financial management and corporate governance, ensuring robust oversight of company operations[81] - The company has established a nomination policy to ensure diversity on the board, considering skills, experience, and knowledge relevant to the company's business[110] - The company has implemented a comprehensive risk management policy to identify, assess, and monitor key risks related to strategic goals[129] - The audit committee is responsible for monitoring significant operational risks and management's handling of these risks[131] Corporate Social Responsibility and ESG - The company identified six highly important ESG issues and ten moderately important issues, focusing on sustainable development management[168] - The company has established an ESG governance structure led by the board of directors, ensuring effective implementation of related policies[163] - The company has implemented strict regulations to combat corruption and fraud, including regular compliance training for senior management and employees[135] - The company has established a whistleblowing policy to report suspicious activities, ensuring confidentiality and protection for whistleblowers[135] - The company has achieved ISO13485:2016 certification for its medical device quality management system, ensuring compliance with regulatory requirements[172] - The company has established a comprehensive quality control program covering the entire product lifecycle, ensuring strict management at all stages from R&D to finished products[178] - The company has implemented measures to ensure sensitive data is handled in compliance with applicable laws and regulations[133] Employee and Gender Diversity - The company employed 392 full-time employees as of December 31, 2023, an increase from 375 in 2022[69] - The board consists of eight male members and one female member, with a commitment to gender diversity and plans to appoint more female directors in the future[126] - The company aims to maintain a minimum of one female director and has achieved 228 female employees, representing 58% of the total workforce[126] - Employee gender ratio as of December 31, 2023, is approximately 42% male to 58% female[127] - The company emphasizes the importance of training and development opportunities for female employees to enhance gender diversity at all levels[126] Supply Chain and Environmental Impact - The company has established a supplier management system with 353 suppliers, including 338 in China and 15 overseas[186] - The company has implemented a green supply chain initiative, encouraging suppliers to use environmentally friendly materials and practices[191] - The company is committed to green operations, focusing on energy conservation and reducing environmental impact[193] - The company achieved a 22% year-on-year reduction in electricity consumption during the reporting period[197] - The company promotes energy-saving concepts among employees and implements measures to maximize energy efficiency[197]

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 40,950,000, an increase of 50.8% compared to RMB 27,149,000 in 2022[2] - Gross profit for the same period was RMB 31,052,000, representing a 60.4% increase from RMB 19,362,000 in 2022[2] - The net loss for the year narrowed to RMB (105,746,000), a 10.6% improvement from RMB (118,316,000) in the previous year[2] - Revenue from customer contracts for medical devices and consumables reached RMB 40,950,000 in 2023, up from RMB 27,149,000 in 2022, representing a growth of approximately 50.5%[24] - Other income increased to RMB 13,259,000 in 2023 from RMB 8,750,000 in 2022, marking a rise of about 51.4%[28] - Government grants accounted for RMB 12,025,000 in 2023, compared to RMB 7,542,000 in 2022, reflecting an increase of approximately 59.5%[28] - The group recorded a pre-tax loss of RMB 105,746,000 for 2023, an improvement from a loss of RMB 118,316,000 in 2022, representing a reduction of approximately 10.5%[33] - The company reported a net loss reduction from RMB 118.3 million for the year ended December 31, 2022, to RMB 105.8 million for the year ended December 31, 2023[90] Assets and Liabilities - Non-current assets increased to RMB 62,906,000 in 2023 from RMB 49,655,000 in 2022[9] - Current assets decreased to RMB 149,915,000 in 2023 from RMB 264,208,000 in 2022, reflecting a significant reduction in cash and cash equivalents[9] - Total equity decreased to RMB 173,460,000 in 2023 from RMB 259,389,000 in 2022, indicating a decline in the company's net worth[10] - Trade receivables remained unchanged at RMB 74,000 for both 2023 and 2022, with a full impairment provision applied[36][40] - Other receivables increased to RMB 22,088,000 in 2023 from RMB 17,858,000 in 2022, marking an increase of approximately 23%[42] - Trade payables decreased to RMB 906,000 in 2023 from RMB 1,763,000 in 2022, a decline of about 48.7%[44] - Other payables and accrued expenses totaled RMB 25,637,000 in 2023, down from RMB 37,275,000 in 2022, representing a decrease of approximately 31.3%[45] - Cash and cash equivalents decreased from RMB 226.4 million as of December 31, 2022, to RMB 103.4 million as of December 31, 2023, a reduction of RMB 123.0 million or 54.3%[91] - Total liabilities as of December 31, 2023, were RMB 11.0 million, slightly down from RMB 11.4 million as of December 31, 2022[93] Research and Development - R&D expenses increased from RMB 59.9 million for the year ended December 31, 2022, to RMB 76.1 million for the year ended December 31, 2023, a rise of 27.0% primarily due to increased personnel costs and materials used in ongoing R&D projects[83] - The company has developed a comprehensive product portfolio, including 14 cryoablation products and 9 non-cryoablation products, with 8 products already commercialized[47] - The company plans to accelerate clinical development and commercialization of its pipeline products, focusing on minimally invasive cryoablation therapy and expanding its product portfolio[76] - The company aims to continue developing various underlying technologies and selectively expand its global business[76] Regulatory Approvals and Clinical Trials - The company received approval from the National Medical Products Administration for its cardiac cryoablation system in December 2023[3] - The cardiac cryoablation system passed GMP review in January 2024, indicating readiness for market introduction[3] - The company completed patient recruitment for the confirmatory clinical trial of the malignant stenosis cryoablation system[3] - The asthma cryoablation system and COPD cryo-spray treatment system entered the confirmatory clinical trial phase in March 2023[3] - The Cryofocus cryoablation system, designed for hypertension treatment, is expected to receive approval from the National Medical Products Administration in the second half of 2025[51] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected approval in the second half of 2027[52] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with registration documents expected to be submitted in the second half of 2025[53] - The asthma cryoablation system also entered confirmatory clinical trials in March 2023, with anticipated registration submission in the second half of 2025[54] - The malignant stenosis cryoablation system is in confirmatory clinical trials, with patient recruitment completed and expected registration submission in Q2 2024[55] - The benign stricture cryoablation system is expected to enter confirmatory clinical trials in January 2024, with product registration submission anticipated in Q4 2024 and approval expected in H1 2026[56] - The lung nodule cryoablation system entered feasibility clinical trials in August 2023, with product registration submission expected in H2 2026 and approval anticipated in H2 2027[57] - The cough cryo-spray therapy system is currently in feasibility clinical trials, with product registration submission expected in H1 2025 and approval anticipated in H2 2026[58] - The tuberculosis cryo-spray therapy system is also in feasibility clinical trials, with product registration submission expected in H2 2025 and approval anticipated in H2 2026[60] - The frozen adhesion treatment system received approval for supporting cryotherapy equipment in December 2023 and is expected to receive approval for single-use cryo-probes in January 2024, with market approval anticipated in January 2024[61] Corporate Governance and Compliance - The group has adopted new and revised Hong Kong Financial Reporting Standards for the current financial year, with no impact on the measurement, recognition, or presentation of any items in the financial statements[14] - The group has not recognized deferred tax assets or liabilities for temporary differences, and the revisions have no effect on the financial statements[16] - The group operates primarily in the medical consumables and devices sector, with nearly all revenue generated from sales in mainland China[22] - The company has adopted corporate governance principles and has complied with all applicable provisions of the corporate governance code throughout the reporting period[100] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has provided independent opinions on financial reporting procedures and internal controls[103] - The audit committee reviewed and confirmed that the annual financial performance for the year ending December 31, 2023, complies with relevant accounting standards and regulations[104] - The company is committed to compliance with corporate governance standards as outlined in the listing rules[114] Employee and Operational Insights - The company employed 392 full-time employees as of December 31, 2023, an increase from 375 employees in 2022, with total employee benefit expenses amounting to approximately RMB 116.9 million[98] - The company maintains the required public float as per listing rules[110] - The company is focused on maintaining transparency and communication with stakeholders[113] - The company will provide necessary information to shareholders regarding the annual report and general meeting in a timely manner[112] - The company emphasizes the importance of shareholder participation in the annual general meeting[111]

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 18,914,000, an increase of 83.5% compared to RMB 10,306,000 for the same period in 2022[5] - Gross profit for the same period was RMB 14,638,000, up from RMB 7,088,000, reflecting a gross margin improvement[5] - The net loss for the period was RMB (47,428,000), slightly higher than the loss of RMB (44,850,000) in the previous year[5] - Revenue increased from RMB 10.3 million for the six months ended June 30, 2022, to RMB 18.9 million for the six months ended June 30, 2023, representing an increase of RMB 8.6 million or 83.5%[33] - Gross profit rose from RMB 7.1 million for the six months ended June 30, 2022, to RMB 14.6 million for the six months ended June 30, 2023, with a gross margin increase from 68.8% to 77.4%[35] - The company incurred a loss before tax of RMB 47,428 thousand, slightly higher than the loss of RMB 44,850 thousand reported in the previous year[81] - The company reported a total comprehensive loss of RMB 47,674 thousand for the period, compared to RMB 44,762 thousand in the previous year[82] - The company recorded a loss attributable to ordinary equity holders of RMB 43,402,000 for the six months ended June 30, 2023, compared to a loss of RMB 42,698,000 in the same period of 2022[107] Research and Development - Research and development expenses increased to RMB (34,330,000) from RMB (22,807,000), indicating a focus on innovation and product development[5] - Research and development expenses increased significantly to RMB 34,330,000 for the six months ended June 30, 2023, up from RMB 22,807,000 in the same period of 2022, reflecting a growth of 50.6%[102] - The company has established a comprehensive intellectual property portfolio with 131 patents and 52 patent applications as of June 30, 2023[30] - The company aims to expand its product portfolio based on its cryoablation technology platform and selectively expand its global business[32] Product Development and Clinical Trials - The company has entered the confirmatory clinical trial phase for its asthma cryoablation system and COPD cryospray treatment system as of March 2023[6] - Patient recruitment for the confirmatory clinical trial of the malignant stenosis cryoablation system is over 75% complete[6] - A registration application has been submitted for the cryoadhesion treatment system, indicating progress in product pipeline[6] - The company has commercialized eight products as of June 30, 2023, with a comprehensive product portfolio targeting vascular intervention and NOTES[8] - The Cryofocus cryoablation system is designed for hypertension treatment and is expected to receive regulatory approval from the National Medical Products Administration (NMPA) in the second half of 2025[11] - The company's cardiac cryoablation system for treating paroxysmal atrial fibrillation is anticipated to gain NMPA approval in the fourth quarter of 2023[10] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected NMPA approval in the second half of 2027[12] - The chronic obstructive pulmonary disease (COPD) cryo-spray treatment system entered confirmatory clinical trials in March 2023, with NMPA submission expected in the second half of 2025 and approval in the second half of 2026[13] - The asthma cryoablation system is also in confirmatory clinical trials, with NMPA submission expected in the second half of 2025 and approval in the second half of 2026[14] - The malignant stenosis cryoablation system is in confirmatory clinical trials, with NMPA submission expected in the third quarter of 2023 and approval anticipated in the fourth quarter of 2024[15] - The benign stenosis cryoablation system is in feasibility clinical trials, with NMPA submission expected in the fourth quarter of 2024 and approval in the first half of 2026[16] - The lung nodule cryoablation system is currently in preclinical research and is expected to submit registration documents to the National Medical Products Administration (NMPA) in the second half of 2026, with approval anticipated in the second half of 2027[17] - The cough cryo-spray treatment system is in feasibility clinical trials, with plans to submit registration documents to the NMPA in the first half of 2025 and expected approval in the second half of 2026[18] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with registration submission planned for the second half of 2025 and approval expected in the second half of 2026[19] - The frozen adhesion treatment system has submitted a registration application and is expected to receive NMPA approval in the first quarter of 2024[20] - The bladder cryoablation system was approved by the NMPA in June 2022 and was commercialized in China in December 2022[21] - The gastric cryoablation system is in feasibility clinical trials, with registration submission expected in the second half of 2025 and approval anticipated in the second half of 2026[22] - The esophageal cryo-spray treatment system is in feasibility clinical trials, with plans to submit registration documents in the second half of 2025 and expected approval in the first half of 2027[23] - The atrial fibrillation pulsed field ablation (PFA) system is in preclinical research, with expected NMPA approval in the first half of 2027[27] Market and Industry Trends - The Chinese interventional cryotherapy device market is experiencing strong growth, driven by factors such as an aging population and increasing chronic disease prevalence[7] - The company aims to leverage its unique liquid nitrogen cryoablation technology and advanced flexible catheter technology to establish high entry barriers in the market[7] Financial Position and Cash Flow - Cash and cash equivalents decreased from RMB 2,264 million as of December 31, 2022, to RMB 1,590 million as of June 30, 2023, a reduction of RMB 674 million or 29.8%[46] - Net cash used in operating activities for the six months ended June 30, 2023, was RMB 582 million, primarily due to significant R&D expenditures[46] - Total debt as of June 30, 2023, was RMB 10,033 million, down from RMB 11,371 million as of December 31, 2022[49] - The current ratio improved to 8.0 as of June 30, 2023, compared to 5.8 as of December 31, 2022[50] - The asset-to-liability ratio decreased to 13.6% as of June 30, 2023, from 17.4% as of December 31, 2022[50] - Capital expenditures for the six months ended June 30, 2023, were RMB 1,812 million, down from RMB 2,236 million for the same period in 2022[48] - The company has no significant investments or acquisitions during the reporting period[53] - The company employed 384 full-time employees as of June 30, 2023, with total employee benefit expenses of approximately RMB 480 million for the six months ended June 30, 2023[55] - The company has utilized HKD 41.70 million of the net proceeds, leaving HKD 98.20 million unutilized[60] - 58.20% of the net proceeds are allocated for the R&D and commercialization of the bladder cryoablation system, with expected full utilization by 2024[60] - 15.70% of the net proceeds are designated for the R&D and commercialization of the endoscopic stapler, with expected full utilization by 2023[60] Governance and Compliance - The audit committee has reviewed and confirmed that the interim financial results for the six months ended June 30, 2023, comply with relevant accounting standards and regulations[62] - The company has confirmed that all directors and supervisors complied with the standard code of conduct throughout the reporting period[58] - The company has not incurred any additional disclosure obligations under the listing rules as of June 30, 2023[66] - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[61] - The board does not recommend the distribution of an interim dividend for the reporting period[57] Shareholder Structure - Major shareholders include Ms. Li with 91,369,084 unlisted shares (38.21%) and 43,411,972 H-shares (18.16%), and Mr. Lu with 91,369,084 unlisted shares (38.21%) and 41,664,172 H-shares (17.42%) as of June 30, 2023[72] - The company has a significant concentration of ownership, with major shareholders controlling over 70% of the unlisted shares and H-shares combined[72] - The overall market position and shareholder structure indicate a diversified investment base, enhancing the company's stability and growth potential[75]

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 18,914,000, an increase of 83.5% compared to RMB 10,306,000 for the same period in 2022[2] - Gross profit for the same period was RMB 14,638,000, up 106.5% from RMB 7,088,000 in 2022[2] - The company reported a loss of RMB (47,428,000) for the six months ended June 30, 2023, compared to a loss of RMB (44,850,000) in the prior year, reflecting a 3.2% increase in losses[2] - Revenue from the sale of medical devices and consumables reached RMB 18,914,000 in the six months ended June 30, 2023, compared to RMB 10,306,000 in the same period of 2022, representing an increase of 83.5%[17] - The group’s total income for the six months ended June 30, 2023, was RMB 6,929,000, compared to RMB 5,619,000 in the same period of 2022, reflecting an increase of 23.3%[19] - Other income included government grants of RMB 3,035,000, down from RMB 3,510,000 in the previous year, a decrease of 13.5%[19] - The group reported a net foreign exchange loss of RMB 3,179,000 for the six months ended June 30, 2023, compared to a loss of RMB 1,436,000 in the same period of 2022, indicating a deterioration in foreign exchange performance[20] - The group’s pre-tax loss for the six months ended June 30, 2023, included costs of sold inventory amounting to RMB 4,276,000, compared to RMB 3,218,000 in the same period of 2022, an increase of 32.9%[20] - The company reported a basic loss per share of RMB 0.18 for the six months ended June 30, 2023, compared to RMB 0.19 for the same period in 2022, with a weighted average of 239,110,000 shares issued during the period[25] Research and Development - Research and development expenses increased to RMB (34,330,000) from RMB (22,807,000), representing a 50.6% increase year-over-year[2] - The company has established a product development team with 98 internal R&D staff and 37 clinical operation team members as of June 30, 2023[51] - The company holds 131 patents and has 52 patent applications as of June 30, 2023, protecting its core technologies[51] - R&D expenses increased from RMB 22.8 million to RMB 34.3 million, a rise of RMB 11.5 million or 50.5%[60] - Employee costs accounted for RMB 18.5 million (53.8%) of total R&D expenses in 2023, compared to RMB 12.4 million (54.4%) in 2022[59] - Clinical trial expenses rose to RMB 4.0 million (11.8%) in 2023 from RMB 2.0 million (8.8%) in 2022[59] Clinical Trials and Product Development - The asthma cryoablation system and COPD cryospray treatment system entered the confirmatory clinical trial phase in March 2023[3] - Patient recruitment for the malignant stenosis cryoablation system confirmatory clinical trial has completed over 75%[3] - The company has submitted a registration application for its cryoadhesion treatment system[3] - The malignant stenosis cryoablation system is in confirmatory clinical trial stage as of June 30, 2023, with registration documents expected to be submitted to the National Medical Products Administration in Q3 2023 and approval anticipated in Q4 2024[37] - The benign stenosis cryoablation system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in Q4 2024 and approval anticipated in H1 2026[38] - The lung peripheral nodule cryoablation system is in preclinical research stage as of June 30, 2023, with registration documents expected to be submitted in H2 2026 and approval anticipated in H2 2027[39] - The cough cryo-spray treatment system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in H1 2025 and approval anticipated in H2 2026[40] - The tuberculosis cryo-spray treatment system is in feasibility clinical trial stage as of June 30, 2023, with registration documents expected to be submitted in H2 2025 and approval anticipated in H2 2026[41] - The frozen adhesion treatment system has submitted registration application as of June 30, 2023, with approval expected in Q1 2024[42] - The bladder cryoablation system received approval from the National Medical Products Administration in June 2022 and was commercialized in China in December 2022[42] Assets and Liabilities - Total non-current assets as of June 30, 2023, were RMB 47,365,000, a decrease from RMB 49,655,000 as of December 31, 2022[7] - Current assets decreased to RMB 209,313,000 from RMB 264,208,000, indicating a reduction in liquidity[7] - Total equity as of June 30, 2023, was RMB 221,654,000, down from RMB 259,389,000 at the end of 2022[10] - Trade receivables as of June 30, 2023, amounted to RMB 93,000,000, with a provision for impairment of RMB 74,000,000, resulting in a net trade receivable of RMB 19,000,000[27] - Trade payables as of June 30, 2023, were RMB 4,169,000, compared to RMB 1,763,000 as of December 31, 2022[29] - Total liabilities as of June 30, 2023, were RMB 10,033 million, a reduction from RMB 11,371 million as of December 31, 2022, representing a decrease of about 11.8%[73] - The current ratio improved to 8.0 as of June 30, 2023, compared to 5.8 as of December 31, 2022, indicating enhanced liquidity[74] - The quick ratio also increased to 7.1 as of June 30, 2023, from 5.3 as of December 31, 2022, reflecting better short-term financial health[74] - The debt-to-asset ratio decreased to 13.6% as of June 30, 2023, down from 17.4% as of December 31, 2022, suggesting a stronger equity position[74] Management and Governance - Liu Wei was appointed as an executive director effective from the date of approval at the shareholders' annual meeting on June 16, 2023[84] - Li Cuiqin resigned from her position as the employee representative supervisor and chairman of the supervisory board effective May 31, 2023[85] - Li Jiawei was elected as the employee representative supervisor and chairman of the supervisory board effective May 31, 2023[86] - The audit committee reviewed and confirmed that the interim financial results for the six months ended June 30, 2023, comply with relevant accounting standards and regulations[87] - The board did not recommend the distribution of an interim dividend for the reporting period[80] Market Outlook and Strategy - The company provided a positive outlook for the next quarter, projecting a revenue growth of 20%[91] - New product launches are expected to contribute an additional 10% to overall revenue in the upcoming fiscal year[91] - The company is investing in R&D, allocating 12% of its revenue towards new technology development[91] - Market expansion plans include entering three new international markets by the end of the fiscal year[91] - The company is considering strategic acquisitions to enhance its market position, targeting a 5% increase in market share[91] - The board emphasized the importance of maintaining operational efficiency, aiming for a 3% reduction in costs[91] - Customer satisfaction ratings improved by 8% following recent service enhancements[91] - The company plans to increase its marketing budget by 15% to support new product launches and market expansion efforts[91]

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 27,149,000, an increase of 21.5% from RMB 22,426,000 in 2021[5] - Gross profit for 2022 was RMB 19,362,000, up from RMB 15,545,000 in 2021, reflecting a gross margin improvement[5] - The company reported a net loss of RMB 118,316,000 for 2022, a slight improvement from a loss of RMB 126,497,000 in 2021[5] - Cash and cash equivalents increased to RMB 226,422,000 in 2022 from RMB 157,867,000 in 2021, indicating improved liquidity[5] - Revenue increased from RMB 224 million for the year ended December 31, 2021, to RMB 271 million for the year ended December 31, 2022, representing a growth of RMB 47 million or 21.1%[41] - Overall gross profit rose from RMB 155 million for the year ended December 31, 2021, to RMB 194 million for the year ended December 31, 2022, with gross margin improving from 69.3% to 71.3%[42] - Other income and gains surged from RMB 44 million for the year ended December 31, 2021, to RMB 114 million for the year ended December 31, 2022, primarily due to increased government subsidies and currency exchange gains[43] - Research and development expenses decreased from RMB 898 million for the year ended December 31, 2021, to RMB 599 million for the year ended December 31, 2022, a decline of 33.3%[45] - Administrative expenses increased from RMB 508 million for the year ended December 31, 2021, to RMB 838 million for the year ended December 31, 2022, an increase of 65.0%[45] - Cash and cash equivalents rose from RMB 1,579 million as of December 31, 2021, to RMB 2,264 million as of December 31, 2022, an increase of 43.4%[52] - Capital expenditures for the year ended December 31, 2022, amounted to RMB 70 million, down from RMB 124 million for the year ended December 31, 2021[54] - Total debt increased to RMB 11,371 million as of December 31, 2022, from RMB 9,001 million in 2021, representing a 26.3% increase[56] - Current ratio decreased to 5.8 as of December 31, 2022, down from 6.7 in 2021, indicating a decline in short-term liquidity[57] - Quick ratio also decreased to 5.3 in 2022 from 6.3 in 2021, reflecting a similar trend in liquidity[58] - The debt-to-asset ratio rose to 17.4% in 2022 compared to 15.0% in 2021, suggesting an increase in leverage[57] - Capital commitments for property and machinery amounted to RMB 2,052 million as of December 31, 2022, up from RMB 1,094 million in 2021, indicating ongoing investment plans[59] - The company plans to retain all future profits for business operations and expansion, with no dividend policy in the foreseeable future[169] Product Development and Innovation - The company received approval for the bladder cryoablation system from the National Medical Products Administration in June 2022 and commercialized it in December 2022[10] - The endoscopic stapler was approved in August 2022 and commercialized in October 2022, marking it as one of the first of its kind in China[10] - The heart cryoablation system registration application was submitted in July 2022, with expected approval in Q2 2023[10] - The company aims to leverage its established commercialization capabilities to enhance product market entry following regulatory approvals[10] - The company has 15 additional products in the pipeline, with several in various stages of clinical development, including three products expected to complete clinical trials in Q2 2023[13] - The vascular intervention cryoablation products are in Phase III trials, with commercialization expected in the second half of 2025[13] - The company is committed to ongoing research and development to enhance its product offerings and maintain its competitive edge in the market[12] - The cardiac cryoablation system is designed for the treatment of paroxysmal atrial fibrillation and is expected to receive regulatory approval in Q2 2023[18] - The Cryofocus cryoablation system, aimed at treating hypertension, is undergoing confirmatory clinical trials with anticipated regulatory approval in H2 2025[18] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected regulatory approval in H1 2026[18] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with plans to submit registration documents in H2 2025 and seek approval in H2 2026[18] - The asthma cryoablation system is in confirmatory clinical trials, with expected registration submission in H2 2025 and approval in H2 2026[21] - The malignant stricture cryoablation system is in confirmatory clinical trials, with plans to submit registration documents in Q3 2023 and seek approval in Q4 2024[22] - The benign stricture cryoablation system is in feasibility clinical trials, with expected registration submission in Q4 2024 and approval in H1 2026[23] - The lung nodule cryoablation system is in preclinical research, with anticipated registration submission in H2 2026 and approval in H2 2027[24] - The cough cryo-spray treatment system is in feasibility clinical trials, with expected registration submission in H1 2025 and approval in H2 2026[25] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with plans for registration submission in H2 2025 and approval in H2 2026[26] - The company aims to expand its product portfolio based on its cryoablation technology and plans to selectively expand its global business[40] Market Outlook and Strategy - The company anticipates rapid industry growth driven by economic recovery, increased public health awareness, and an aging population in China[11] - The company focuses on minimally invasive cryoablation technology, primarily targeting urological, respiratory, and gastrointestinal diseases, with a comprehensive product portfolio established since its founding in 2013[12] - The cryoablation device market in China is experiencing strong growth, driven by factors such as an aging population, increasing chronic disease prevalence, and supportive government policies[12] - The aging population and the growing patient base are expected to further drive the demand for cryoablation devices in the coming years[12] - The company anticipates continued market expansion due to technological advancements and the increasing demand for cryoablation therapies[12] - Future outlook includes expansion into new markets and the development of innovative medical technologies[74] - The company is actively pursuing mergers and acquisitions to enhance its product offerings and market presence[75] - New product development is centered around minimally invasive medical devices, targeting structural heart disease[76] Corporate Governance and Management - Liu Wei was appointed as CFO and Secretary of the Board in December 2021, with responsibilities including financial planning and investor relations[91] - Duong has over 24 years of engineering experience, previously holding positions at various companies including Parker Hannifin Corporation and Endocare Inc.[93] - Liu Yulong has over 17 years of experience in the pharmaceutical and medical device industry, previously working at Medtronic and Anhui Anke Biotechnology[95] - Zhao Kuiwen has been with the company since September 2017, serving as the Chief Technology Officer and responsible for R&D activities[97] - Qu Jihong joined the company in March 2022 as Chief Medical Officer, focusing on product applications and international market strategies[98] - The management team has extensive experience, with key members holding advanced degrees in engineering and business[77] - The company emphasizes its commitment to expanding its market presence and enhancing its product offerings through strategic initiatives[98] - The board consists of two executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balanced power structure[111] - The company has adopted a code of conduct for securities trading by directors and senior management, confirming compliance since the listing date[110] - The company has established a comprehensive training program for new employees to understand its corporate culture and policies[104] - The board has ensured compliance with the corporate governance code since the listing date, maintaining effective accountability[105] - The board of directors consists of both executive and independent non-executive directors, with a term of three years, subject to re-election[115] - The company has established three committees: Audit Committee, Remuneration Committee, and Nomination Committee to oversee various aspects of the company's affairs[124] Risk Management and Compliance - The company has implemented a comprehensive risk management policy to continuously identify, assess, and monitor key risks related to its strategic objectives[151] - The board is responsible for establishing and reviewing the effectiveness of the internal control system, which includes financial, operational, and compliance controls[152] - The audit committee reviews and approves the company's risk management policies to ensure alignment with corporate objectives[148] - The company conducts annual reviews of its risk management and internal control systems, deeming them effective and adequate[151] - Regular training is provided to management and sales teams regarding compliance with the "two-invoice system" and other applicable laws[152] - The company monitors the implementation progress of the "two-invoice system" across different provinces[152] - The company has established channels for independent non-executive directors to express opinions openly and confidentially when necessary[144] - The company has implemented strict internal control measures to handle sensitive data, including desensitization and prior board approval for data transmission[154] - As of December 31, 2022, the company reported no claims or allegations related to bribery or corruption, indicating effective internal controls[157] Environmental, Social, and Governance (ESG) - The board is responsible for overseeing ESG-related matters and regularly reviews ESG risks and performance[179] - The company aims to enhance its governance structure and risk management systems continuously[180] - In 2022, the company identified 18 ESG material issues, categorizing them into 6 highly important, 9 moderately important, and 3 generally important issues, focusing on sustainable long-term development[190] - The company has established a dedicated ESG working group to coordinate and execute ESG-related matters, reporting directly to the board of directors[185] - The company has committed to social responsibility and sustainable development, focusing on innovation in cryogenic technology and life sciences[184]