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先健科技(01302.HK):镍钛合金动脉导管未闭封堵器进入创新医疗器械特别审查程序
Ge Long Hui· 2025-08-22 00:07
Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its nickel-titanium alloy patent ductus arteriosus (PDA) occluder has entered the special review process for innovative medical devices, marking the sixteenth product of the company to enter this process [1][2] Group 1: Product Details - The PDA occluder is designed for interventional treatment of congenital heart PDA and features a full nickel-titanium metal structure that allows for both "venous forward" and "arterial retrograde" release paths [2] - The product is made from woven nickel-titanium alloy wire and employs a self-expanding asymmetric double-disc structure, providing flexibility in choosing the implantation path based on patient conditions [2] - Compared to traditional forward pathways, the retrograde approach simplifies the procedure, reduces operation time, and offers better treatment options for patients with venous system contraindications [2] Group 2: Market Implications - The company holds independent intellectual property rights for the product, and clinical trials for registration in China are progressing steadily [2] - The entry into the special review process is expected to shorten the registration timeline, accelerating the product's market launch [2] - The anticipated launch of the product is expected to benefit PDA patients and expand the company's product range, thereby promoting growth in the medical device sector [2]
先健科技(01302) - 自愿性公佈 - 镍鈦合金动脉导管未闭封堵器进入创新医疗器械特别审查程序
2025-08-22 00:01
LifeTech Scientific Corporation 先健科技公司 (在開曼群島註冊成立的有限公司) (股份代號:1302) 自願性公佈 鎳鈦合金動脈導管未閉封堵器 進入創新醫療器械特別審查程序 本公佈乃由先健科技公司(「本公司」,連同其附屬公司稱為「本集團」)自願作出。 本公司董事(「董事」)會(「董事會」)欣然宣佈,於二零二五年八月二十日,本公司收 到國家藥品監督管理局(「國家藥品監督管理局」)的正式書面通知,確認鎳鈦合金動 脈導管未閉封堵器「該產品」)進入國家藥品監督管理局創新醫療器械特別審查程序 (「該程序」)。該產品為本公司第十六個進入國家藥品監督管理局該程序的產品。 動脈導管未閉(PDA)是臨床上最常見的先天性心臟病之一,約佔所有先天性心臟病 發病率的12%至15%。如果未能及時治療,可能導致肺動脈高壓、心力衰竭等嚴重 併發症。經導管PDA封堵術因其微創、安全、恢復快等優勢,已逐漸成為符合適應 症患者的首選治療方案。然而,由於 PDA存在不同結構和尺寸,且患者的血管條件 各異,對封堵器械的適應性提出了更高挑戰,使臨床更需要兼顧多種情況的創新器 械。 香港交易及結算所有限公司與香港聯合交易 ...
先健科技(01302)上涨5.0%,报2.31元/股
Jin Rong Jie· 2025-08-19 05:23
8月19日,先健科技(01302)盘中上涨5.0%,截至13:06,报2.31元/股,成交8188.02万元。 先健科技专注于心脑血管和外周血管介入医疗器械的研发、生产及全球化发展,产品在国内市场占据领 先地位,并拓展至全球120多个国家和地区。公司已获得2,426项高质量专利,15款产品通过NMPA创新 医疗器械审查程序,持续推动技术突破与国际化发展。 8月29日,先健科技将披露2025财年中报。 本文源自:金融界 作者:行情君 截至2024年年报,先健科技营业总收入13.04亿元、净利润2.22亿元。 ...
先健科技(01302) - 董事会会议通告
2025-08-11 08:44
LifeTech Scientific Corporation 先健科技公司 (在開曼群島註冊成立的有限公司) (股份代號:1302) 董事會會議通告 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佈的內容概不負責,對其準確性或完 整性亦不發表任何聲明,並明確表示,概不對因本公佈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。 1) 考慮及批准本公司及其附屬公司(「本集團」)截至二零二五年六月三十日止六個 月的未經審核中期業績,並批准將於香港交易及結算所有限公司及本公司網站 刊登的本集團的未經審核中期業績公佈; 2) 考慮派發中期股息(如有); 3) 考慮暫停辦理本公司股份過戶登記手續(倘有需要);及 4) 處理任何其他事項(如有)。 先健科技公司(「本公司」)董事會(「董事會」)謹此公佈,將訂於二零二五年八月 二十九日(星期五)舉行董事會會議,以商討下列事項: 承董事會命 先健科技公司 執行董事、主席兼首席執行官 謝粵輝 香港,二零二五年八月十一日 於本公佈日期,董事會成員包括本公司執行董事謝粵輝先生、劉劍雄先生及阮杏梅女士;本公司非 執行董事姜峰先生;及本公司獨立非執行董事 ...
智通港股解盘 | 第三方制裁仍有隐忧 消费“三剑客”在发力
Zhi Tong Cai Jing· 2025-08-06 12:53
Market Overview - The A-share market showed strong performance with the Shanghai Composite Index steadily rising, while the Hong Kong stock market experienced a narrow fluctuation, closing up by 0.03% [1] - Concerns in the market are heightened due to the U.S. President Trump's shortened ultimatum for sanctions against Russia, now set at 10 days, with potential impacts on India and other countries [1] - The U.S. is also set to impose significant tariffs on semiconductor chips and pharmaceuticals, with drug tariffs reaching as high as 250% [1] Company Developments - Jingtai Technology announced a pipeline cooperation agreement with DoveTree worth approximately HKD 470 billion (USD 59.9 billion), leading to a stock surge of over 12% [2] - A-share company Weixin New Materials faced regulatory scrutiny after a stock price surge related to the "embodied intelligent robot" concept and control change expectations [2] - The Shanghai government released a plan for the development of the embodied intelligence industry, aiming for breakthroughs in core algorithms and technologies by 2027 [2] Industry Trends - The 2025 World Robot Conference is set to showcase over 100 new products, nearly double from last year, indicating a growing interest in robotics [3] - The U.S. student loan delinquency rate has reached 12.9%, the highest in 21 years, which may influence Federal Reserve decisions on interest rates [3] - The steel and paper industries are experiencing positive momentum, with companies like Maanshan Steel and Nine Dragons Paper seeing significant stock price increases [3] Defense Sector Insights - The military industry is gaining traction with significant contracts, such as the sale of the Hongqi-9 air defense system and the export of submarines to Pakistan [4] - China Shipbuilding Defense announced a profit increase of 213.25% to 267.73% for the first half of the year, leading to a stock rise of nearly 8% [4] Consumer Market Activity - The new consumption sector is becoming active, with companies like Pop Mart seeing increased attention at recent toy exhibitions [5] - The liquor industry is also responding to market trends, with new product launches and stock price increases [5] Aviation Sector Developments - Cathay Pacific announced an $8.1 billion order for 14 Boeing 777-9 aircraft, marking its first deal with Boeing in 12 years, despite concerns over the safety record of Boeing aircraft [7] - The long delivery timeline for the 777-9 model raises potential issues regarding aircraft aging and maintenance [7] Energy Sector Updates - The State Grid reported record electricity usage due to high temperatures, with peak load reaching 1.233 billion kilowatts, an increase of 53 million kilowatts from last year [8] - Coal prices have risen significantly, impacting the steel industry, which is maintaining high production levels [8] Automotive Sector Performance - XPeng Motors reported a record monthly delivery of 36,717 vehicles in July, a year-on-year increase of 229.4% [10] - The company is expanding its presence in Europe, with significant sales growth and new model launches [11][12]
先健科技(01302) - 截至2025年7月31日之股份发行人的证券变动月报表
2025-08-06 06:19
FF301 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: 先健科技公司 (在開曼群島註冊成立的有限公司) 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01302 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 | ...
港股午评|恒生指数早盘涨0.18% 煤炭股涨幅居前
智通财经网· 2025-08-06 04:05
Group 1: Market Performance - Hang Seng Index rose by 0.18%, gaining 45 points to close at 24,947 points; Hang Seng Tech Index increased by 0.03% [1] - Hong Kong stock market saw a morning trading volume of 120.6 billion HKD [1] Group 2: Notable Stock Movements - Coal stocks led the gains, with China Shenhua (01088) up 3.61% and Yanzhou Coal (01171) up 4.1%, as the fifth round of coking coal price hikes took effect [1] - Crystal International (02228) surged over 8% after signing a pipeline cooperation agreement with DoveTree, with a total order size of approximately 47 billion HKD and an initial payment of 51 million USD received [1] - Tsugami (01651) rose by 4.68% following a nearly 40% increase in Q1 net profit from its Japanese division and positive machine tool production data for June [1] - Xianjian Technology (01302) increased by 6.97%, with expectations of gradual price adjustments for related products in the second half of the year [1] - Pop Mart (09992) gained 6.31%, driven by strong demand for its proprietary IP, with Morgan Stanley highlighting its undervalued platform [1] - China Shipbuilding Defense (00317) rose over 7%, anticipating a more than double year-on-year increase in net profit for the first half of the year [1] - BYD Electronics (00285) increased by over 6%, benefiting from AI-driven growth in the liquid cooling market and entry into the Nvidia supply chain [1] - Wuling Motors (00305) surged over 10% after announcing a profit warning, with mid-term net profit soaring nearly threefold as the company actively expands in the new energy sector [1] Group 3: Declining Stocks - Qilu Expressway (01576) fell by 6.37% after issuing a profit warning, expecting a year-on-year decline of approximately 21.62% in mid-term net profit [2] - Dongfang Zhenxuan (01797) dropped over 7% amid public relations issues and the closure of Sam's Club member stores, despite its stock price doubling since early July [3] - Boya Interactive (00434) declined by over 6%, projecting a year-on-year profit decrease of 25% to 35% for the first half of the year [4]
先健科技涨超10% 机构料公司集采调价相关产品下半年有望逐步出清 关注行业估值修复
Zhi Tong Cai Jing· 2025-08-06 03:03
Core Viewpoint - The article discusses the recent performance of Xianjian Technology (01302) and the impact of new pricing regulations on the medical device industry in China, particularly focusing on the aortic stent market and the expected recovery in the sector by 2025 [1] Group 1: Company Performance - Xianjian Technology's stock rose over 10%, currently trading at 2.2 HKD with a transaction volume of 214 million HKD [1] - The company is affected by new pricing regulations set by the National Healthcare Security Administration, which aims to reduce excessive markups in the supply chain [1] Group 2: Industry Insights - The price adjustments due to centralized procurement are expected to lead to a decline in the ex-factory prices of related products, impacting the company's revenue and profit in the second half of 2024 [1] - A one-year price adjustment period is anticipated to gradually clear by the second half of 2025, potentially reversing the current challenges faced by the company [1] - Citic Securities predicts that as policies ease and centralized procurement clears, many medical device companies will see performance and valuation recovery [1] - The medical device sector is expected to present increasing investment opportunities, particularly in international markets, with several companies projected to achieve high growth in international business by 2025 [1] - The strong performance of the Hong Kong medical device sector this year is likely to influence the A-share market, highlighting ongoing investment opportunities in both markets [1]
港股异动 | 先健科技(01302)涨超10% 机构料公司集采调价相关产品下半年有望逐步出清 关注行业估值修复
智通财经网· 2025-08-06 03:02
Core Viewpoint - The article discusses the recent performance of Xianjian Technology (01302) and the impact of new pricing regulations on the medical device industry in China, highlighting potential recovery and growth opportunities in the sector [1] Company Summary - Xianjian Technology's stock rose over 10%, currently trading at 2.2 HKD with a trading volume of 214 million HKD [1] - The company is affected by new pricing regulations from the National Healthcare Security Administration, which requires 12 domestic and foreign companies to re-evaluate the pricing of thoracic aortic stent products [1] - The price adjustments due to centralized procurement are expected to lead to a decline in the factory prices of related products, impacting the company's revenue and profit in the second half of 2024 [1] Industry Summary - The price adjustments are anticipated to clear up by the second half of 2025, potentially reversing the current challenges faced by the company [1] - Citic Securities indicates that as policies ease and centralized procurement clears, many medical device companies will see performance and valuation recovery [1] - The medical device sector is expected to present increasing investment opportunities, particularly from international business growth, with many companies projected to achieve high growth in international revenues by 2025 [1] - The strong performance of the Hong Kong medical device sector is likely to reflect positively on the A-share market, suggesting sustained investment opportunities in both markets [1]
先健科技(01302)上涨5.47%,报2.12元/股
Jin Rong Jie· 2025-08-06 01:42
8月6日,先健科技(01302)盘中上涨5.47%,截至09:30,报2.12元/股,成交517.86万元。 作者:行情君 截至2024年年报,先健科技营业总收入13.04亿元、净利润2.22亿元。 本文源自:金融界 先健科技专注于心脑血管和外周血管介入医疗器械的研发、生产及全球化发展,产品在国内市场占据领 先地位,并拓展至全球120多个国家和地区。公司已获得2,426项高质量专利,15款产品通过NMPA创新 医疗器械审查程序,持续推动技术突破与国际化发展。 ...