CRYOFOCUS(06922)
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 康沣生物(06922) - 董事会会议日期
 2025-07-29 08:31
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) 董事會會議日期 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(「本公司」,連同其附屬公司統稱「本集團」) 董事(「董事」)會(「董事會」)茲宣佈謹定於2025年8月8日(星期五)召開董事會會 議,以(其中包括)審議及通過本集團截至2025年6月30日止六個月之中期業績及 其發佈,以及審議派發中期股息之建議(如有)。 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,2025年7月29日 於本公告日期,董事會包括執行董事李克儉先生、朱軍先生及劉偉先生,非執行 董事呂世文先生及趙春生先生,以及獨立非執行董事高大勇博士、梁顯治先生、 覃正博士及胡赫男博士。 ...
 康沣生物(06922) - 自愿公告哮喘冷冻消融系统获得美国食品监督管理局授予的突破性医疗器械认证
 2025-07-24 13:54
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. 哮喘冷凍消融系統獲得美國食品監督管理局授予的突破性醫療器械認證 本公告乃由康灃生物科技(上海)股份有限公司(「本公司」,連同其附屬公司統稱 為「本集團」)自願作出,以告知本公司股東及潛在投資者有關本集團業務的最新 進展。 本公司欣然宣佈,於2025年7月24日,本集團的哮喘冷凍消融系統(「哮喘冷凍消 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,已獲得美國食品及藥物管理局授予的突破性醫療器械認證。 哮喘冷凍消融系統為用於治療中度及重度哮喘的自主研發冷凍消融系統。在手術 過程中,哮喘冷凍消融系統通過冷凍消融破壞肺部迷走神經,減少過度活化乙醯 膽鹼的釋放(其為哮喘病因),並減少黏液分泌,從而達到治療哮喘的效果。 本公司無法保證哮喘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 ...
 康沣生物(06922) - (1)於2025年6月20日举行的2024年股东周年大会投票表决结果;及...
 2025-06-20 11:04
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) 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. 股東周年大會通告所載全部提呈的決議案均於股東周年大會上以投票方式進行表 決。本公司的香港H股股份過戶登記處香港中央證券登記有限公司及本公司於股 東周年大會上擔任監票人,負責進行點票工作。 全體董事(即李克儉先生、朱軍先生、劉偉先生、呂世文先生、趙春生先生、高 大勇博士、梁顯治先生、覃正博士及胡赫男博士)親身出席或通過電子方式出席 股東周年大會。 股東周年大會投票表決結果 (1)於2025年6月20日舉行的2024年股東周年大會 投票表決結果;及 (2)修訂公司章程 董事會欣然宣佈,股東周年大會通告所載全部提呈的決議案已於股東周年大會 上獲股東以投票表決方式正式通過。 茲提述康灃生物科技(上海)股份有限公司(「本公司」)日期均為2 ...
 康沣生物(06922) - 致非登记股东之通知信函及回条 - 以电子方式发佈公司通讯安排的提示信函
 2025-04-29 08:53
April 30, 2025 Reminder letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated March 14, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", Cryofocus Medtech (Shanghai) Co., Ltd. (the "Company") is writing to remind you that the Company has adopted electronic dissemination of corporate communications (the "Corporate Communications"), which mean any documents issued or to be issued by the Company ...
 康沣生物(06922) - 致登记股东之通知信函及回条 - 以电子方式发佈公司通讯安排的提示信函
 2025-04-29 08:52
Please note that both the English and Chinese versions of all future Corporate Communications will be available electronically on the website of the Company at www.cryofocus.com and the HKEXnews website at www.hkexnews.hk in place of printed copies. Solicitation of electronic contact details Pursuant to Rule 2.07A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, the Company shall despatch to you by electronic means or by post the Actionable Corporate Communication ...
 康沣生物(06922) - 2024年股东周年大会通告
 2025-04-29 08:50
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通告的內容概不負責,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通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) 2024年股東周年大會通告 「H股」指本公司普通股股本中每股面值人民幣1.00元的境外上市外資 普通股,以港元認購及買賣並於聯交所上市; 「有關期間」指由本決議案在股東周年大會上獲通過當日起至下列最早 時限止的期間: 茲通告康灃生物科技(上海)股份有限公司(「本公司」)謹訂於2025年6月20日(星 期五)上午十時正假座中華人民共和國(「中國」)上海市浦東新區康新公路3399弄25號 樓3樓舉行2024年股東周年大會(「股東周年大會」),以考慮及酌情通過下列決議案: 普通決議案 特別決議案 9. 考慮及批准授予董事會一般授權(「一般授權」),在本決議案所載條款及條 件的規限下,於有關期間(定義見下文)內 ...
 康沣生物(06922) - 2024年股东周年大会通函
 2025-04-29 08:49
此乃要件 請即處理 閣下如對本通函或應採取的行動有任何疑問,應諮詢 閣下的股票經紀或其他註冊證券交易商、銀 行經理、律師、專業會計師或其他專業顧問。 閣下如已售出或轉讓名下所有康灃生物科技(上海)股份有限公司股份,應立即將本通函連同隨附的 代表委任表格送交買方或承讓人,或經手買賣或轉讓的銀行、持牌證券交易商或其他代理,以便轉 交買方或承讓人。 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通函的內容概不負責,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通函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. 2025年4月29日 (1) 2024年董事會工作報告; (2) 2024年監事會工作報告; (3) 2024年溢利分派計劃; (4) 2024年經審核綜合財務報表; (5) 2024年年報; (6) 董事薪酬; (7) 監事薪酬; (8) 續聘2025年度核數師; (9) 發行股份的一般授權; (10) 建議修訂公司章程; 康 灃 生 物 科 技( 上 海 )股 份 有 限 公 司 (於 ...
 康沣生物(06922) - 2024 - 年度财报
 2025-04-29 08:48
 Financial Performance - In 2024, the company achieved a revenue of RMB 53.531 million, representing a year-on-year growth of 30.7%[9] - The gross profit for 2024 was RMB 38.410 million, compared to RMB 31.052 million in 2023[8] - The company reported a net loss of RMB 111.277 million for 2024, slightly higher than the loss of RMB 105.746 million in 2023[8] - Revenue increased from RMB 41.0 million for the year ended December 31, 2023, to RMB 53.5 million for the year ended December 31, 2024, representing a growth of RMB 12.5 million or 30.7%[39] - Overall gross profit increased from RMB 31.1 million for the year ended December 31, 2023, to RMB 38.4 million for the year ended December 31, 2024, while gross profit margin decreased from 75.8% to 71.8%[41] - Other income and gains rose from RMB 15.0 million for the year ended December 31, 2023, to RMB 20.7 million for the year ended December 31, 2024, primarily due to increased government subsidies[42]   Assets and Liabilities - As of December 31, 2024, the total current assets were RMB 98.159 million, down from RMB 149.915 million in 2023[8] - The total non-current assets decreased to RMB 51.088 million in 2024 from RMB 62.906 million in 2023[8] - Total debt increased from RMB 11.0 million as of December 31, 2023, to RMB 13.3 million as of December 31, 2024[56] - Current ratio decreased from 4.9 to 1.6, and quick ratio decreased from 4.1 to 1.1 from December 31, 2023, to December 31, 2024[57] - Net cash used in operating activities was RMB 82.9 million for the year ended December 31, 2024, primarily due to significant R&D and administrative expenses[53]   Product Development and Commercialization - The company received NMPA approval for multiple products, including the cardiac cryoablation system and the cryoadhesion treatment system in January 2024[10] - A significant milestone was achieved with the commercialization of the cardiac cryoablation system and cryoadhesion treatment system in September 2024[10] - The product portfolio includes 14 cryo-treatment products and 9 non-cryo treatment products, with 10 already commercialized as of the report date[13] - The company aims to accelerate product commercialization and improve profitability to create greater value for shareholders[11] - The company is focused on expanding its product pipeline in the vascular intervention and respiratory intervention sectors[15]   Research and Development - The company has established a product development team of 70 internal R&D staff and 24 clinical operation staff, focusing on understanding clinical needs and developing new products[36] - The company is actively pursuing innovation in medical technology, with a focus on international product introduction[94] - The company has a strong focus on research and development, with a CTO overseeing R&D activities since 2019[92] - The company is committed to developing new technologies and applications in the medical field, leveraging the expertise of its board members[78]   Management and Governance - The management team includes experienced professionals with over 21 years in the medical industry and over 10 years in auditing[68][70] - The company has a structured governance framework with representatives from various departments, ensuring comprehensive oversight[89] - The board consists of three executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balance of power[109] - The company has implemented a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives[147]   Corporate Culture and Employee Relations - The company emphasizes the importance of corporate culture for long-term business development and sustainable growth[101] - The company has a focus on employee training and development, providing regular feedback and internal and external training on various aspects[64] - The company is committed to compliance with Chinese labor laws, including individual employment contracts and contributions to social insurance funds[64] - The employee gender ratio is approximately 42% male to 58% female as of December 31, 2024[144]   Compliance and Risk Management - The company has implemented strict internal controls to comply with regulations regarding sensitive data handling and anti-corruption measures[151] - The company conducts regular training for management and employees on compliance with applicable laws and regulations, including anti-corruption policies[152] - The company has adopted a whistleblowing policy to encourage employees and stakeholders to report suspicious activities confidentially[154] - The audit committee oversees the implementation of necessary measures to ensure compliance with relevant laws and regulations governing business operations[155]   Environmental, Social, and Governance (ESG) - The report is the third Environmental, Social, and Governance (ESG) report issued by the company, adhering to principles of objectivity, transparency, and comprehensiveness[176] - The company identified 6 highly important ESG issues, 10 moderately important issues, and 2 generally important issues during the reporting period[197] - The company emphasizes the importance of sustainable development in its operations[198] - The company has committed to optimizing its corporate governance structure and ESG management system for sustainable development[186]
 康沣生物(06922) - 2024 - 年度业绩
 2025-03-31 12:52
 Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenue of RMB 53,531,000, an increase of 30.7% compared to RMB 40,950,000 in 2023[2] - The gross profit for the same period was RMB 38,410,000, reflecting a growth of 23.7% from RMB 31,052,000 in the previous year[2] - The net loss for the year was RMB 111,277,000, which is a 5.2% increase from the loss of RMB 105,746,000 in 2023[2] - Revenue from the sale of medical devices and consumables increased to RMB 53,531,000 in 2024 from RMB 40,950,000 in 2023, representing a growth of approximately 30.6%[27] - Government grants received rose to RMB 19,271,000 in 2024 compared to RMB 12,025,000 in 2023, marking an increase of about 60.5%[30] - The total income for 2024 was RMB 20,733,000, up from RMB 14,959,000 in 2023, reflecting an increase of around 38.5%[30] - The company reported a pre-tax loss of RMB 111,143,000 for 2024, compared to a loss of RMB 105,746,000 in 2023, reflecting an increase in losses of approximately 3.9%[33] - The effective tax expense calculated at the group's actual tax rate for 2024 was RMB 134, while the statutory tax expense at a rate of 25% amounted to RMB 27,786,000 for 2024[33] - The basic loss per share attributable to ordinary equity holders of the parent was calculated based on a weighted average of 239,110,000 shares for both 2024 and 2023, with no adjustments for dilution due to unexercised options[35] - The company’s revenue from a single major customer amounted to RMB 2,784,000 in 2024, down from RMB 5,752,000 in 2023, showing a decline of approximately 51.5%[26] - The company’s contract liabilities recognized as revenue from medical consumables were RMB 964,000 in 2024, down from RMB 3,160,000 in 2023, indicating a decrease of about 69.5%[28]   Regulatory Approvals and Product Development - The company achieved several regulatory approvals, including the market approval for the cryo-adhesion treatment system in January 2024[3] - The benign stricture cryoablation system entered the confirmatory clinical trial phase in January 2024[3] - The company submitted a registration application for its anti-reflux system in May 2024[3] - The cardiac cryoablation system is expected to receive approval from the National Medical Products Administration (NMPA) in December 2023, following its registration application submitted in July 2022[46] - The Cryofocus cryoablation system, designed for resistant hypertension, is anticipated to gain NMPA approval in the second half of 2027[47] - The pulmonary hypertension cryoablation system is currently in preclinical research and is expected to receive NMPA approval in the second half of 2029[48] - The COPD cryo-spray treatment system is entering confirmatory clinical trials, with registration documents expected to be submitted to the NMPA in the second half of 2025 and approval anticipated in the second half of 2026[49] - The asthma cryoablation system is also in confirmatory clinical trials, with plans to submit registration documents to the NMPA in the second half of 2025 and approval expected in the second half of 2026[50] - The malignant stenosis cryoablation system is designed for ablating malignant airway tumors and reducing the frequency of airway restenosis, with clinical trials initiated in April 2021 and regulatory submission expected in May 2024[51] - The benign stenosis cryoablation system, based on liquid nitrogen, entered the confirmatory clinical trial phase in January 2024, with regulatory submission anticipated in the first half of 2027[52] - The lung peripheral nodule cryoablation system is currently in the feasibility clinical trial phase, with expected regulatory submission in the second half of 2026[53] - The cough cryo-spray treatment system is in the feasibility clinical trial phase, with regulatory submission expected in the first half of 2025[54] - The tuberculosis cryo-spray treatment system is also in the feasibility clinical trial phase, with anticipated regulatory submission in the second half of 2025[55] - The frozen adhesion treatment system received regulatory approval in January 2024 and was commercialized in September 2024[56] - The bladder cryoablation system was approved by the National Medical Products Administration in June 2022 and commercialized in December 2022[57] - The gastric cryoablation system is currently in the feasibility clinical trial phase, with expected regulatory submission in the second half of 2025[58] - The esophageal cryo-spray treatment system is in the feasibility clinical trial phase, with anticipated regulatory submission in the second half of 2025[59] - The lung nodule localization needle was commercialized in May 2019 after receiving regulatory approval in March 2019[60] - The atrial fibrillation pulsed field ablation (PFA) system is currently in feasibility clinical trials, with expectations for regulatory approval in the first half of 2027[63] - The anti-reflux system is expected to submit a registration application in May 2024, with anticipated regulatory approval in the first half of 2025[64]   Financial Position and Assets - The total assets decreased from RMB 182,039,000 in 2023 to RMB 89,432,000 in 2024, indicating a significant reduction in asset value[7] - The company’s cash and cash equivalents dropped from RMB 103,402,000 in 2023 to RMB 45,458,000 in 2024[7] - Trade receivables remained unchanged at RMB 74,000 for both 2024 and 2023, with a full impairment provision reflecting a 100% expected credit loss rate[39] - Other receivables decreased from RMB 22,088,000 in 2023 to RMB 22,828,000 in 2024, with impairment losses increasing from RMB 620,000 to RMB 901,000[40] - Trade payables increased from RMB 906,000 in 2023 to RMB 1,205,000 in 2024, indicating a rise in short-term liabilities[41] - Total debt increased from RMB 1,101 million in 2023 to RMB 1,332 million in 2024[85] - Current ratio decreased from 4.9 in 2023 to 1.6 in 2024, indicating reduced liquidity[86]   Corporate Governance and Compliance - The company has adopted corporate governance principles and has complied with all applicable provisions of the corporate governance code during the reporting period[101] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has reviewed the financial performance for the year ended December 31, 2024, ensuring compliance with relevant accounting standards[104] - Ernst & Young has agreed with the financial figures reported for the year ended December 31, 2024, confirming consistency with the group's consolidated financial statements[105] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[103] - The board will continue to monitor and review its corporate governance practices to maintain high standards[102]   Employee and Operational Metrics - As of December 31, 2024, the group employed 276 full-time employees, a decrease from 392 in 2023, with total employee benefits expenses amounting to approximately RMB 100.7 million[95] - The company aims to maintain strict control over outstanding receivables to minimize credit risk, with management regularly reviewing overdue balances[37] - The company has a comprehensive product portfolio with 14 cryotherapy products and nine non-cryotherapy products in development, with ten products already commercialized[44] - The company focuses on minimally invasive cryotherapy, utilizing unique liquid nitrogen ablation technology and advanced flexible catheter technology[43] - The company aims to expand its product portfolio based on its cryoablation technology and plans to selectively expand its global business[69]   Expenses and Financial Management - R&D expenses decreased from RMB 761.3 million in 2023 to RMB 734.55 million in 2024, a reduction of RMB 26 million or 3.5%[74] - Administrative expenses increased from RMB 690 million in 2023 to RMB 812 million in 2024, an increase of RMB 122 million or 17.6%[75] - Sales and distribution expenses surged from RMB 57 million in 2023 to RMB 141 million in 2024, an increase of RMB 84 million or 148.2%[76] - Financing costs rose from RMB 7 million in 2023 to RMB 11 million in 2024, an increase of RMB 4 million or 67.3%[78] - Net cash used in operating activities was RMB 829 million for the year ending December 31, 2024, primarily due to significant R&D and administrative expenses[82] - Cash and cash equivalents decreased from RMB 1,034 million in 2023 to RMB 455 million in 2024, a reduction of RMB 579 million or 56.0%[82] - The company reported a net loss increase from RMB 1,058 million in 2023 to RMB 1,113 million in 2024[81]   Shareholder and Meeting Information - The board does not recommend the distribution of a final dividend for the reporting period, consistent with 2023[96] - On March 7, 2024, the China Securities Regulatory Commission approved the conversion and listing of 29,341,981 non-listed shares into H-shares, which commenced trading on September 6, 2024[97] - The board proposed amendments to the company's articles of association and changes to the use of net proceeds from the global offering, which were approved at the annual general meeting on June 14, 2024[98] - A total lease agreement was renewed with Ningbo Linrong for a period of three years starting January 1, 2025, with the transaction constituting a continuing connected transaction[99] - The annual general meeting is scheduled for June 20, 2025, with a suspension of H-share transfer registration from June 17 to June 20, 2025, to determine eligibility for voting[112][113] - The company maintains the required public float as per listing rules as of the announcement date[111] - The company plans to submit a special resolution for amendments to the articles of association at the annual general meeting[107] - The annual report for the fiscal year ending December 31, 2024, will be published in accordance with listing rules[114]
 康沣生物(06922) - 董事会提名委员会工作细则
 2025-03-31 12:34
康灃生物科技(上海)股份有限公司 董事會提名委員會工作細則 第一章 總則 第二章 人員組成 1 3 第九條 提名委員會對董事會負責,委員會的提案提交董事會審議;控股股 東在無充分理由或可靠證據的情況下,應充分尊重提名委員會的建 議,否則不能提出替代性的董事、高級管理人員人選。 第十條 公司提供委員會履行職責所必需的工作條件。董事會秘書為委員履 行職責提供協助,包括但不限於介紹情況、提供材料、協調相關部 門、籌備提名委員會會議並協助提名委員會決議的執行等。 第一條 為了進一步健全康灃生物科技(上海)股份有限公司(以下簡稱「公 司」或「本公司」)董事和高級管理人員的選任,完善公司治理結構, 根據《中華人民共和國公司法》(以下簡稱「《公司法》」)、《香港聯合 交易所有限公司證券上市規則》(以下簡稱「《上市規則》」)以及公司 章程,公司特設立董事會(「董事會」)提名委員會(「提名委員會」), 並制定本工作細則(「工作細則」)。 第二條 提名委員會是董事會按照公司董事會決議設立的專門委員會,主要 負責就公司董事、高級管理人員的人選、選擇標準和程式進行討論 並向董事會提出建議。 第三條 本工作細則所稱的董事和高級管理人員 ...