Workflow
BASECARE-B(02170)
icon
Search documents
贝康医疗-B(02170):Gems胚胎培养液系列(VitBase胚胎处理液)获国家药监局颁发医疗器械注册证
智通财经网· 2025-08-26 12:04
Core Insights - The company, Beikang Medical-B (02170), announced that its Gems embryo culture medium series (VitBase embryo processing fluid) received a Class III medical device registration certificate from the National Medical Products Administration (NMPA) on August 25, 2025 [1] - This approval highlights the support from the government for the innovative transformation of medical products acquired overseas, positioning the company as one of the few globally to hold CE, FDA, and TGA certifications for assisted reproductive fluids [1] - The VitBase embryo processing fluid is the first of 11 products in the GEMS embryo culture medium series to receive medical device approval, marking a significant step towards the localization of high-quality embryo culture technology in China [2] Company Overview - The Gems embryo culture medium series is developed by Genea Biomedx Pty Ltd., a wholly-owned subsidiary of BMX Holdco Pte. Ltd., which is fully owned by the company [1] - The approval of VitBase embryo processing fluid is based on over 30 years of clinical experience from Genea Biomedx, ensuring high product quality while enhancing accessibility and supply chain security [1] Industry Context - Historically, core culture media used in IVF laboratories in China have relied heavily on overseas brands, making the safety, stability, and long-term clinical validation of these products critical for both doctors and patients [1] - The successful registration of the VitBase embryo processing fluid lays the groundwork for the subsequent localization of the entire product line in China [2]
贝康医疗(02170.HK):Gems胚胎培养液系列(VitBase胚胎处理液)获国家药监局颁发医疗器械注册证
Ge Long Hui· 2025-08-26 12:01
长期以来,中国IVF实验室使用的核心培养液主要依赖海外品牌。培养液作为影响试管婴儿成功率的关 键因素之一,其安全性、稳定性和长期临床验证资料对医生和患者而言至关重要。公司此次获批的 VitBase胚胎处理液,源自Genea Biomedx 30余年的临床经验积累,结合本土化生产和监管要求,既延续 了国际高水准的产品品质,又显著提升了可及性和供应链保障。 VitBase胚胎处理液是GEMS胚胎培养液系列11款培养液中的首个获得医疗器液的获批不仅意味着国际一 流的培养液技术逐步实现国产化落地,同时也将为行业带来械注册证的产品,这为后续全品系培养液在 中国的国产化奠定了基础。 格隆汇8月26日丨贝康医疗(02170.HK)发布公告,公司的Gems胚胎培养液系列(VitBase胚胎处理液)于 2025年8月25日获得国家药品监督管理局颁发的三类医疗器械注册证(注册证号:国械注进 20253180356)。 公司的Gems胚胎培养液系列(VitBase胚胎处理液)隶属于公司全资拥有的BMX Holdco Pte. Ltd.的全资 子公司Genea Biomedx Pty Ltd.开发的GEMS培养液系列。此次获批不仅体 ...
贝康医疗(02170) - 自愿公告 - Gems胚胎培养液系列(VitBase胚胎处理液)获国家药...
2025-08-26 11:44
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所產生或 因依賴該等內容而引致的任何損失承擔任何責任。 Suzhou Basecare Medical Corporation Limited 蘇 州 貝 康 醫 療 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:2170) – 1 – 長期以來,中國IVF實驗室使用的核心培養液主要依賴海外品牌。培養液作為 影響試管嬰兒成功率的關鍵因素之一,其安全性、穩定性和長期臨床驗證資 料對醫生和患者而言至關重要。本公司此次獲批的VitBase胚胎處理液,源自 Genea Biomedx 30餘年的臨床經驗積累,結合本土化生產和監管要求,既延續 了國際高水準的產品品質,又顯著提升了可及性和供應鏈保障。 VitBase胚胎處理液是GEMS胚胎培養液系列11款培養液中的首個獲得醫療器液 的獲批不僅意味著國際一流的培養液技術逐步實現國產化落地,同時也將為 行業帶來械註冊證的產品,這為後續全品系培養液在中 ...
贝康医疗-B尾盘涨近6% Gems培养液获得注册证 推动辅助生殖用液国产化
Zhi Tong Cai Jing· 2025-08-26 07:19
Core Viewpoint - Beikang Medical's stock surged nearly 6% in late trading, reflecting positive market sentiment following the announcement of regulatory approval for its VitBase embryo handling solution, marking a significant milestone in China's assisted reproduction sector [1] Company Summary - Beikang Medical's VitBase has received registration certification from the National Medical Products Administration (NMPA), indicating a breakthrough in the domestic high-end culture medium market [1] - The VitBase product is part of Beikang's international brand BMX and is recognized as a leading choice among Chinese embryologists, with a history of 30 years [1] - The GEMS series includes 11 products that have received EU CE certification, 8 products approved by the US FDA, and 11 products compliant with Australia's TGA standards, covering the entire assisted reproduction process [1] Industry Summary - The approval of VitBase signifies a shift in the assisted reproduction industry in China, breaking a 30-year monopoly held by imported brands and positioning domestic products on an international level [1]
港股异动 | 贝康医疗-B(02170)尾盘涨近6% Gems培养液获得注册证 推动辅助生殖用液国产化
智通财经网· 2025-08-26 07:16
Group 1 - Beikang Medical-B (02170) saw a nearly 6% increase in stock price, currently trading at 3.91 HKD with a transaction volume of 4.3854 million HKD [1] - The company announced that its Gems culture medium (embryo handling medium VitBase) has officially received registration certification from the National Medical Products Administration (NMPA), marking a milestone in China's assisted reproduction field [1] - This certification signifies that domestic high-end culture media have entered the international leading ranks, breaking the monopoly of imported brands that has lasted for over 30 years [1] Group 2 - VitBase is part of Beikang's international brand BMX and is a star product in the GEMS series, which has been favored by Chinese embryologists for 30 years [1] - Currently, 11 products have received EU CE certification, 8 products have been approved by the US FDA, and 11 products meet Australian TGA standards, covering the entire process of assisted reproduction [1]
贝康医疗Gems培养液获注册证,开启国产化新篇章
Ge Long Hui A P P· 2025-08-26 02:55
Core Viewpoint - Beikang Medical has received approval for its embryo handling solution VitBase, marking a significant step in the domestic production of its GEMS embryo culture media series [1] Group 1: Product Approval and Significance - The approval of VitBase is the first domestic registration certificate for Beikang Medical's GEMS embryo culture media series, indicating a new chapter in the domestic production of assisted reproductive consumables [1] - GEMS embryo culture media is developed by Singapore's BMX company, which has a 30-year research history and is recognized globally for its assisted reproductive products [1] Group 2: Product Credentials and Market Position - The initial formula of GEMS was previously licensed to Cook Medical and has been favored by Chinese embryologists for 30 years [1] - Currently, 11 products have received EU CE certification, 8 products have been approved by the US FDA, and 11 products meet Australian TGA standards, covering the entire assisted reproductive process [1] Group 3: Clinical Impact - The VitBase embryo handling solution, when used in conjunction with Beikang Medical's previously approved Geri non-interfering time-lapse incubator, significantly enhances blastocyst formation rates, clinical pregnancy rates, and live birth rates after the first transfer [1]
贝康医疗(02170.HK)Gems培养液喜获注册证,开启国产化新篇章
Ge Long Hui· 2025-08-26 02:26
Core Viewpoint - Suzhou Beikang Medical has received approval from the National Medical Products Administration (NMPA) for its Gems culture medium (embryo handling liquid VitBase), marking a significant milestone in the localization of reproductive liquids in China and demonstrating the company's full industry chain capability from international acquisition to domestic registration [1][3][4]. Group 1: Product Approval and Significance - The approval of VitBase is the first registration certificate among the 11 products in the GEMS series, laying the foundation for the subsequent localization of the entire product line in China [4]. - This approval reflects the national support for the innovative transformation of overseas medical products and positions Beikang Medical as one of the few companies globally with CE, FDA, and TGA certifications for reproductive liquids [3][4]. Group 2: Market Impact and Benefits - The introduction of the Gems culture medium is expected to enhance supply chain security, reduce reliance on imports, and promote a more reasonable pricing system, benefiting more patients [4]. - The product is based on over 30 years of clinical experience from the globally recognized Sydney IVF center, ensuring high product quality while improving accessibility and supply chain reliability [3][4]. Group 3: Future Outlook - Beikang Medical aims to provide a more stable culture environment for embryos and improve the success rates of IVF in China through the localization of Gems culture medium [8]. - The company plans to continue developing and registering high-end reproductive medical products, gradually achieving full-chain domestic substitution [8].
贝康医疗(02170) - 董事会会议通告
2025-08-19 08:48
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所產生或 因依賴該等內容而引致的任何損失承擔任何責任。 Suzhou Basecare Medical Corporation Limited 蘇 州 貝 康 醫 療 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:2170) 董事會會議通告 蘇州貝康醫療股份有限公司(「本公司」)董事會(「董事會」)謹此宣佈,董事會 會議將於2025年8月29日(星期五)舉行,藉以(其中包括)考慮及批准本公司及 其附屬公司截至2025年6月30日止六個月之中期業績及其發佈,並考慮建議派 發中期股息(如有)。 承董事會命 蘇州貝康醫療股份有限公司 董事長兼總經理 梁波博士 中國蘇州,2025年8月19日 截至本公告日期,董事會由執行董事梁波博士、孔令印先生及姜雋超女士;非執行董事趙業 先生、王偉鵬先生及凌洋先生;以及獨立非執行董事康熙雄博士、林兆榮先生及楊樹標博士 組成。 ...
贝康医疗(02170) - 截至二零二五年七月三十一日止月份之股份发行人的证券变动月报表
2025-08-05 08:37
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 蘇州貝康醫療股份有限公司 呈交日期: 2025年8月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02170 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 82,713,835 | RMB | | 1 | RMB | | 82,713,835 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 82,713,835 | RMB | | 1 | RMB | | 82,713,835 | | 2. 股份分類 | 普通股 | ...
港股生物科技股集体上涨,北海康成-B涨近19%,歌礼生物-B涨15%,亚盛医药-B涨9%,嘉和生物-B涨超8%,贝康医疗涨7%
Ge Long Hui· 2025-08-05 05:57
Group 1 - The Hong Kong biotechnology stocks collectively rose, with notable increases in several companies' stock prices [1][2] - Beihai Kangcheng-B saw a rise of nearly 19%, while other companies like Gilead Sciences-B and Ascentage Pharma-B also experienced significant gains of over 15% and 9% respectively [1][2] - The overall trend indicates a positive sentiment in the biotechnology sector, with multiple companies achieving gains of over 5% [1][2] Group 2 - Specific stock performance includes: Beihai Kangcheng-B at 18.99% increase, Gilead Sciences-B at 15.30%, and Ascentage Pharma-B at 9.48% [2] - The market capitalization of these companies varies significantly, with Gilead Sciences-B at approximately 11.477 billion and Ascentage Pharma-B at about 29.86 billion [2] - Other notable performers include Jiahua Bio-B and Beikang Medical-B, both showing increases of over 7% [1][2]