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FDA突破性医疗器械认证
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赛诺医疗: 赛诺医疗科学技术股份有限公司关于股票交易严重异常波动的公告
Zheng Quan Zhi Xing· 2025-08-13 11:20
Core Viewpoint - The stock of Sino Medical Technology Co., Ltd. has experienced significant abnormal fluctuations, with a cumulative price increase of 100% over five consecutive trading days, prompting the company to issue a notice regarding the situation [1][4][5]. Stock Trading Abnormalities - The stock price of Sino Medical increased by 30% over three consecutive trading days from August 11 to August 13, 2025 [1][4]. - The closing price on August 13, 2025, was 29.50 yuan per share, with the recent price increase surpassing that of most peers in the industry and the Shanghai Composite Index [2][7]. - The rolling price-to-earnings (P/E) ratio of the company is 1701.41, significantly deviating from the industry average P/E ratio of 33.59 [2][7]. Company Disclosures - The company has disclosed that it received conditional approval from the FDA for a new drug-eluting stent system on July 22, 2025, and a breakthrough medical device designation for its COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter on August 7, 2025 [1][3][5]. - The breakthrough designation by the FDA provides priority review and support for product development and clinical trials, although it does not guarantee subsequent approval for market entry [3][8]. Shareholder and Control Information - The company confirmed that there are no undisclosed significant matters affecting stock trading, including major asset restructuring or debt restructuring, as of the announcement date [2][5][6]. - The company’s major shareholders and actual controllers have not reported any significant events that could influence stock trading [2][5].
赛诺医疗: 赛诺医疗科学技术股份有限公司关于股票异常波动的公告
Zheng Quan Zhi Xing· 2025-08-08 16:23
Core Viewpoint - The stock of Sino Medical Technology Co., Ltd. experienced an abnormal trading fluctuation, with a cumulative closing price drop of 30% over two consecutive trading days on August 7 and August 8, 2025 [1][2]. Group 1: Abnormal Trading Fluctuation - The stock trading of Sino Medical on August 7 and August 8, 2025, showed a cumulative closing price drop of 30%, qualifying as an abnormal trading fluctuation according to the Shanghai Stock Exchange regulations [1][2]. - The company conducted a self-examination and confirmed that no significant media reports or market rumors could impact the stock price, and there are no undisclosed major information affecting the trading price [1][3]. Group 2: Company Disclosures - The company previously disclosed that its new drug-eluting stent system received conditional approval from the FDA on July 22, 2025, and a subsidiary's product received breakthrough medical device certification from the FDA on August 7, 2025 [1][3]. - The company has not identified any need to correct or supplement previously disclosed information, and its normal production and operation status remains unaffected [1][3][4]. Group 3: Shareholder and Control Information - The company confirmed that its controlling shareholders and actual controllers do not have any major matters that could influence the abnormal trading fluctuation, including significant asset restructuring or debt restructuring [2][3].
8月7日涨停股:22股封单资金超过1亿元
| | | | | | | 8月 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / 日 / | | | --- | --- | --- | --- | --- | --- | --- | --- | | 代码 | 简称 | 收盘价 | 换手率 | 涨停板封单 | 封車资金 | 進板 | 涨停原因 | | | | (元) | (%) | (ケチ) | (16元) | 大数 | | | 002354 | 天娱数科 | 7.45 | 22.21 | 39.66 | 2.95 | 1 | 物理AI+具身智能+空间计算+参股芯明智能 | | 688110 | 东芯股份 | 73.20 | 14.65 | 3.30 | 2.42 | 1 | 砺算科技+GPU+存算联一体化 | | 688108 | 赛诺医疗 | 17.03 | 2.10 | 13.55 | 2.31 | 1 | FDA突破性医疗器械认证+神经介入创新+中报预增 | | 002148 | 北纬科技 | 1 ...