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新华制药(000756) - 关于取得二十碳五烯酸乙酯软胶囊药品注册证书的公告
2025-06-05 09:45
山东新华制药股份有限公司 关于取得二十碳五烯酸乙酯软胶囊药品注册证书的公告 证券代码:000756 证券简称:新华制药 公告编号:2025-35 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。 近日,山东新华制药股份有限公司("新华制药"或"本公司")收到国家药品监督管理 局核准签发的二十碳五烯酸乙酯软胶囊(以下简称"本品")《药品注册证书》,现将相关情 况公告如下: 一、基本情况 药品名称:二十碳五烯酸乙酯软胶囊 剂型:胶囊剂 规格:1.0g;0.5g 药品分类:处方药 注册分类:化学药品4类 申请人:山东新华制药股份有限公司 申请事项:药品注册(境内生产) 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注 册的有关要求,批准注册,发给药品注册证书。质量标准、说明书、标签及生产工艺照所附 执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。 二、 其他相关信息 2023年11月,新华制药向国家药品监督管理局药品审评中心(CDE)递交二十碳五烯酸 乙酯软胶囊上市许可注册申报资料并获受理,2025年6月获得《药品注册证书》 ...
新华制药:二十碳五烯酸乙酯获上市申请批准
news flash· 2025-05-19 08:39
新华制药(000756)公告,近日收到国家药品监督管理局核准签发的二十碳五烯酸乙酯《化学原料药上 市申请批准通知书》。2023年6月,新华制药递交二十碳五烯酸乙酯境内生产化学原料药上市申请注册 申报资料并获受理,2025年5月获得批准通知书,审评结论为批准注册。 ...
智通港股早知道 | 恒生科技指数调入比亚迪股份(01211) 宁德时代(03750)H股发售定价每股263港元
Zhi Tong Cai Jing· 2025-05-18 23:41
Group 1 - Ningde Times has set the H-share offering price at HKD 263.00 per share, with an additional issuance of 17,684,100 shares, representing approximately 15.0% of the total shares available for subscription [1] - The additional shares will be allocated based on an initial ratio of 7.5% for the Hong Kong public offering and 92.5% for the international offering [1] - The H-shares are expected to commence trading on the Hong Kong Stock Exchange on May 20, 2025, at 9:00 AM [1] Group 2 - Moody's has downgraded the U.S. credit rating from AAA to AA1, impacting market sentiment [2] - Major U.S. stock indices showed positive performance, with the Dow Jones up 331.99 points (0.78%) and the S&P 500 up 41.45 points (0.70%) [2] - The Nasdaq China Golden Dragon Index rose by 4.56% over the week, indicating a positive trend for Chinese concept stocks [2] Group 3 - The Hang Seng Index Company announced the quarterly review results, increasing the number of constituent stocks from 83 to 85, with BYD included in the Hang Seng Tech Index [3] Group 4 - The Central Committee of the Communist Party and the State Council have mandated that government procurement of vehicles should prioritize domestic and new energy vehicles [4] Group 5 - The revised regulations prohibit high-end dishes and alcohol in official work meals, emphasizing cost control in government receptions [5] Group 6 - The Financial Secretary of Hong Kong stated that global funds are increasingly flowing towards leading innovative technology companies and future industries [6] Group 7 - The China Securities Regulatory Commission encourages private equity funds to participate in mergers and acquisitions of listed companies, with adjustments to lock-up periods for investments [7][8] Group 8 - WuXi AppTec's subsidiary, Hanbang Technology, was listed on the Shanghai Stock Exchange on May 16, 2025 [9] Group 9 - Weichai Power expects significant growth in sales of its M-series large-bore engines and data center products, driven by strong industry demand [10] Group 10 - Shandong Xinhua Pharmaceutical is the largest producer of ibuprofen raw materials in China, with an annual production capacity exceeding 8,000 tons, accounting for 40% of global capacity [11] - The company holds a 62.66% market share in China and exports 60% of its total production, primarily to high-end markets in Europe and the U.S. [11]
港股收评:网易绩后大涨13% 创新药板块反弹 新华制药涨近9%
news flash· 2025-05-16 08:17
金十数据5月16日讯,港股全天窄幅震荡,恒指收跌0.46%,报23345.05点。恒生科技指数收跌0.31%, 报5281.34点。截至今日收盘,恒指大市成交额1907.22亿港元。盘面上,线上零售商板块领跌,蚂蚁金 服概念股走低,创新药反弹,黄金股回暖,汽车股局部走强。个股方面,网易(09999.HK)涨13%,第四 范式(06682.HK)涨11.6%,山东新华制药股份(00719.HK)涨近9%,京东健康(06618.HK)、中国生物制药 (01177.HK)涨3.85%,比亚迪股份(01211.HK)、石药集团(01093.HK)涨超3%,阿里巴巴(09988.HK)跌 4.27%,美团(03690.HK)跌近3%。绿茶集团(06831.HK)尾盘直线下挫,上市首日收跌12.52%,成交额超 6亿港元。 港股收评:网易绩后大涨13% 创新药板块反弹 新华制药涨近9% ...
异动盘点0516|网易高开超10%,正大企业国际早盘涨超32%,部门药品股早盘走高;比特币概念股走低
贝塔投资智库· 2025-05-16 04:15
Group 1: Company Performance - NetEase-S (09999) saw a significant increase of 10.89% in stock price after reporting Q1 2025 net revenue of RMB 28.8285 billion, a year-on-year increase of 7.4%, and gross profit of RMB 18.5 billion, up 8.6% [1] - H&H International Holdings (01112) rose over 8% as the market speculated on the ergotamine concept, with its Swisse brand showing strong performance in high-growth segments [2] - China Gold International (02099) experienced a stock price increase of over 5% after reporting a 351% rise in Q1 revenue to USD 273 million [2] Group 2: Clinical and Pharmaceutical Developments - Shandong Xinhua Pharmaceutical (00719) surged over 14% as COVID-19 infections showed an upward trend, with the company preparing for Phase II clinical trials of OAB-14 [1] - Innovent Biologics (01801) rose nearly 3% after announcing the completion of the first patient dosing in the Phase III clinical study of Ma Shidu peptide for obesity [1] - Kangxi Biologics (06185) increased over 3% after receiving approval from the Indonesian drug regulatory authority for its inhaled tuberculosis vaccine clinical trial [1] Group 3: Market Trends and Reactions - The Nasdaq Golden Dragon China Index fell over 2%, with notable declines in popular Chinese stocks such as Tiger Brokers (TIGR.US) down over 8% and Beike (BEKE.US) down over 5% [3] - UnitedHealth Group (UNH.US) experienced a significant drop of over 15% following reports of a U.S. Department of Justice investigation into potential insurance fraud [3] - Bitcoin-related stocks declined, with CleanSpark (CLSK.US) down nearly 6% and Coinbase (COIN.US) down over 7%, as Bitcoin itself fell over 1.5% [3]
港股药品股拉升,新华制药涨16%,三生制药涨5.6%,石药集团、信达生物涨超2%!近一个月来,全国多地均出现新冠流行趋势
Ge Long Hui· 2025-05-16 03:19
格隆汇5月16日|港股药品股拉升明显,其中,山东新华制药一度大涨近16%表现抢眼,天大药业、德 琪医药涨超6%,三生制药、远大医药涨5.6%,石药集团、信达生物涨超2%。 【免责声明】本文仅代表作者本人观点,与和讯网无关。和讯网站对文中陈述、观点判断保持中立,不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考,并请自行承担全部责任。邮箱: news_center@staff.hexun.com | 代码 | 名称 | 最新价 | 涨跌幅 ▽ | | --- | --- | --- | --- | | 00719 | 山东新华制药股 | 6.260 | 9.82% | | 00932 | 顺腾国际控股 | 0.025 | 8.70% | | 00455 | 天大药业 | 0.152 | 6.29% | | 06996 | 德琪医药-B | 3.440 | 6.17% | | 01530 | 三生制药 | 12.100 | 5.77% | | 00512 | 远大医药 | 8.650 | 5.62% | | 00950 | 李氏大药厂 | 1.400 | 4.48% | | 0689 ...
港股概念追踪|新冠感染现抬头趋势 抗病毒感染药物企业受关注(附概念股)
Zhi Tong Cai Jing· 2025-05-16 03:15
Group 1 - The monitoring report from the Chinese CDC indicates an upward trend in the COVID-19 positive rate in April, with southern provinces showing higher rates than northern ones [1] - In Hong Kong, the COVID-19 positive rate increased from 1.71% to 8.21% over four weeks, indicating a rising trend in the region [1] - Taiwan reported a significant increase in emergency visits related to COVID-19, with a 66% rise in cases and additional severe cases and deaths [1] Group 2 - The Chinese CDC reported an increase in the COVID-19 positive rate among flu-like cases in emergency departments, rising from 7.5% to 16.2% [2] - Among hospitalized severe acute respiratory infection cases, the COVID-19 positive rate increased from 3.3% to 6.3% during the monitoring period [2] - The new coronavirus has surpassed rhinovirus as the leading cause of emergency visits for flu-like cases in the specified three-week period [2] Group 3 - Relevant pharmaceutical companies in the Hong Kong stock market include Shandong Xinhua Pharmaceutical (00719), Jinhongzi (06896), Sanofi (01530), and Dongyangguang Changjiang Pharmaceutical (01558) [3]
港股制药板块拉升,山东新华制药股份涨超10%
news flash· 2025-05-16 01:57
港股制药板块拉升,山东新华制药(000756)股份涨超10%,凯莱英(002821)涨超4%,信达生物、 翰森制药、远大医药跟涨。 无需港股通,A股账户就能T+0买港股>> ...
新华制药: 关于召开2024年度周年股东大会的通知
Zheng Quan Zhi Xing· 2025-05-14 09:20
证券代码:000756 证券简称:新华制药 公告编号:2025-31 山东新华制药股份有限公司 关于召开 2024 年度周年股东大会的通知 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述 或重大遗漏。 一、召开会议的基本情况 公司于 2025 年 4 月 28 日召开第十一届董事会第七次会议,批准公司召开 2024 年度周年股东大 会("周年股东大会")以审议公司第十一届董事会第六次会议及第十一届监事会第六次会议审议 通过的有关议案。据此,公司现发出关于召开 2024 年度周年股东大会的通知。 (1)现场会议召开时间:2025 年 6 月 13 日下午 2 时 (2)网络投票时间:通过深圳证券交易所交易系统进行网络投票的具体时间为 2025 年 6 月 13 日上午 9:15-9:25,9:30-11:30,下午 13:00-15:00;通过深圳证券交易所互联网投票系统进行网络 投票的时间为自 2025 年 6 月 13 日上午 9:15 至下午 15:00 期间的任意时间。 二、会议审议事项 | 提案编 | 提案名称 | | | | 备注 | | | | --- | -- ...
新华制药:多个产品获批,在研产品100多个
Core Viewpoint - The company has made significant progress in product approvals and innovation, enhancing its market position and revenue potential in the pharmaceutical industry. Group 1: Product Approvals and Sales - In 2025, the company received multiple product approvals, including Mecobalamin tablets and enteric-coated Aspirin tablets, which will enrich its product line in the nervous system category [1] - The sales revenue for Mecobalamin tablets in Chinese public medical institutions was approximately 1.431 billion yuan in 2023, while the sales for enteric-coated Aspirin tablets reached about 3.3 billion yuan [1] Group 2: Research and Development - The company is focusing on R&D in various therapeutic areas, including cardiovascular, analgesics, digestive system, anti-metabolic, nervous system, and narcotic drugs, with over 100 drugs in the development pipeline [2][3] - It has established multiple large R&D platforms and is advancing several first-class innovative drugs, such as OAB-14 for Alzheimer's treatment [2] - The company emphasizes collaboration with academic institutions and has partnerships with over 50 domestic and international research organizations [3] Group 3: Financial Performance - In Q1 2025, the company reported a revenue of 2.43 billion yuan and a net profit of 112 million yuan [4] - For the year 2024, the total revenue was 8.466 billion yuan, reflecting a year-on-year growth of 4.51%, while the net profit was 470 million yuan, slightly declining due to price reductions aimed at market capture [4] - The company plans a high dividend distribution, proposing a payout of 2.5 yuan per 10 shares (including tax) for 2024 [4]