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亚太药业盐酸地尔硫 片一致性评价申请不予批准
Bei Jing Shang Bao· 2025-11-06 13:48
Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The company submitted the consistency evaluation application for Diltiazem Hydrochloride Tablets in November 2024, which was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted in this application could not support the conclusion of bioequivalence [1] - The company stated that this disapproval will not have a significant impact on its current performance and plans to improve the relevant experimental research before reapplying [1]
亚太药业盐酸地尔硫䓬片一致性评价申请不予批准
Bei Jing Shang Bao· 2025-11-06 13:42
Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The application for the consistency evaluation was submitted in November 2024 and was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted could not support the conclusion of bioequivalence [1] - The company stated that this disapproval will not have a significant impact on its current performance and plans to improve the relevant experimental research before resubmitting the application [1]
晚间公告|11月6日这些公告有看头
Di Yi Cai Jing· 2025-11-06 10:17
Corporate Governance - China Aluminum announced the election of He Wenjian as chairman and the appointment of Zhang Ruizhong as general manager, effective immediately [3] - Jiang Guiting, the actual controller and chairman of Jingjin Equipment, has had his detention lifted, allowing him to resume his duties [8] - Biao Bang Co. has terminated its plans for a change in control, with stock resuming trading [7] Industry Developments - Jiangbolong reported that its self-developed main control chip deployment has exceeded 100 million units, with rapid growth expected [4] - Asia Pacific Pharmaceutical received a notice of disapproval for its consistency evaluation application for a drug, which will not significantly impact its current performance [5] - Fuxiang Pharmaceutical successfully passed a cGMP inspection by the FDA, marking its third successful inspection [6] - Huahai Pharmaceutical's subsidiary passed an FDA inspection, enhancing its international market capabilities [13] Financial Performance - Daqin Railway reported a cargo transport volume of 32.51 million tons in October 2025, a year-on-year decrease of 4.7% [18] - Jingji Zhino achieved sales revenue of 317 million yuan from selling 233,300 pigs in October 2025 [19] - Baiyun Airport reported a passenger throughput of 7.64 million in October 2025, a year-on-year increase of 12.04% [20] - Dongfeng Motor's total vehicle production in October 2025 was 6,536 units, a year-on-year decrease of 23.40% [21] - Hongyang Real Estate reported a contract sales amount of 202 million yuan in October 2025 [22] Shareholder Actions - Xintonglian announced that a shareholder plans to reduce its stake by up to 3% [24] - Tonghua Dongbao conducted its first share buyback, acquiring 143,500 shares for 1.29 million yuan [25] - Guoci Materials plans to repurchase shares worth 100 million to 200 million yuan at a price not exceeding 30 yuan per share [26] Project Wins - Dayu Water-saving announced a pre-bid win for a 310 million yuan water conservancy project in Hainan [28] - Zhongjian Technology signed a significant sales contract worth 563 million yuan [29] - Longjian Co. won a project bid worth 441 million yuan for road construction in Heilongjiang [30] - Chongqing Construction's subsidiary won a project bid worth 781 million yuan for a residential project in Chongqing [31]
亚太药业(002370.SZ):盐酸地尔硫䓬片一致性评价申请不予批准
智通财经网· 2025-11-06 08:01
Core Viewpoint - The company, Asia-Pacific Pharmaceutical (002370.SZ), has received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets has been rejected due to insufficient bioequivalence study results [1] Company Summary - The rejected application pertains to Diltiazem Hydrochloride Tablets, which are used for the treatment of angina pectoris and mild to moderate hypertension [1] - The reason for the rejection is that the bioequivalence study submitted does not support a conclusion of bioequivalence [1]
亚太药业(002370.SZ):盐酸地尔硫䓬片收到药品补充申请不予批准通知书
Ge Long Hui A P P· 2025-11-06 07:55
Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370.SZ) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The application for the consistency evaluation was submitted in November 2024 and was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study did not support the conclusion of bioequivalence [1] - The disapproval of Diltiazem Hydrochloride Tablets will not have a significant impact on the company's current performance [1] Group 2 - The company plans to improve the relevant experimental research of the drug and will reapply for approval in the future [1]
亚太药业:盐酸地尔硫䓬片收到药品补充申请不予批准通知书
Ge Long Hui· 2025-11-06 07:47
Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370.SZ) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The application for the consistency evaluation of Diltiazem Hydrochloride Tablets was submitted in November 2024 and accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted could not support the conclusion of bioequivalence [1] - The disapproval of Diltiazem Hydrochloride Tablets will not have a significant impact on the company's current performance, and the company plans to improve the relevant experimental research before resubmitting the application [1]
亚太药业(002370) - 关于收到药品补充申请不予批准通知书的公告
2025-11-06 07:45
证券代码:002370 证券简称:亚太药业 公告编号:2025-091 浙江亚太药业股份有限公司 关于收到药品补充申请不予批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完 整,没有虚假记载、误导性陈述或重大遗漏。 浙江亚太药业股份有限公司(以下简称"公司")于近日收到国 家药品监督管理局下发的关于盐酸地尔硫䓬片一致性评价的申请不 予批准的通知书。现将相关情况公告如下: 一、产品相关情况 三、对公司的影响及风险提示 本次盐酸地尔硫䓬片不予批准不会对公司当期业绩产生重大影 响,后续公司将完善该药品的相关试验研究工作后重新申报申请。药 品研发具有周期长、环节多的特点,容易受到一些不确定性因素的影 响,公司将严格按照相关法律法规及时履行信息披露义务,敬请广大 - 1 - 盐酸地尔硫䓬片适用于心绞痛和轻、中度高血压的治疗。 二、通知书主要内容 产品名称:盐酸地尔硫䓬片 受理号:CYHB2450*** 结论:根据《中华人民共和国药品管理法》的有关规定,经审查, 本品不符合仿制药质量和疗效一致性评价有关要求,不予批准。 公司于2024年11月向国家药品监督管理局递交该产品的一致性 评价申请并予以受理 ...
龙虎榜复盘 | 两岸概念再迎高潮,“马字辈”、冰雪产业逆势走强
Xuan Gu Bao· 2025-11-04 10:30
Group 1: Institutional Trading Insights - A total of 36 stocks were listed on the institutional trading leaderboard, with 19 stocks experiencing net buying and 17 stocks facing net selling [1] - The top three stocks with the highest net buying by institutions were: Haixia Innovation (224 million), Asia-Pacific Pharmaceutical (88.31 million), and Shenzhou Information (63.68 million) [1] Group 2: Company Profiles - Haixia Innovation, a local company in Fujian, specializes in intelligent solutions for building and public safety management, focusing on smart construction and public safety management [2] - The company is backed by four institutions with a net buying amount of 224 million [2] - Xiamen State-owned Assets Supervision and Administration Commission holds a controlling stake in Xiamen Construction Machinery, which primarily manufactures loaders, excavators, and shield machines [4] Group 3: Industry Developments - The 27th Harbin Ice and Snow World is currently under preparation, with the park area expanding to 1.2 million square meters and a total ice and snow usage of 400,000 cubic meters, marking a record high [5]
亚太药业换手率38.87%,龙虎榜上机构买入3.46亿元,卖出2.57亿元
Group 1 - The core point of the article highlights that Asia-Pacific Pharmaceutical's stock rose by 3.90% with a turnover rate of 38.87% and a trading volume of 2.592 billion yuan, indicating strong market interest [2] - Institutional investors net bought 88.31 million yuan worth of shares, with a total buying amount of 346 million yuan and selling amount of 257 million yuan from the top five buying and selling seats [2] - The stock has appeared on the daily trading list 15 times in the past six months, with an average price increase of 2.36% the day after being listed and an average increase of 4.11% over the following five days [2] Group 2 - The main capital flow indicates a net outflow of 104 million yuan today, with large orders contributing to a net outflow of 16.04 million yuan and a net outflow of 87.87 million yuan from larger funds [2] - Over the past five days, the stock has seen a net inflow of 320 million yuan in principal funds, suggesting a positive trend in investor sentiment [2] - Detailed trading data shows that institutional special seats were active in both buying and selling, with significant amounts traded among the top five buying and selling seats [2]
亚太药业成交额创上市以来新高
Group 1 - The core point of the article highlights that Asia-Pacific Pharmaceutical achieved a record trading volume of 2.46 billion yuan, marking the highest since its listing [1] - The latest stock price increased by 3.33%, with a turnover rate of 36.91% [1] - The previous trading day's total transaction volume for the stock was 1.44 billion yuan [1] Group 2 - Asia-Pacific Pharmaceutical Co., Ltd. was established on December 31, 2001, with a registered capital of 745.67 million yuan [1]