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 局核准签发的注射用硫酸艾沙康唑（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 证券代码：000756 证券简称：新华制药 公告编号：2025-34 山东新华制药股份有限公司 关于取得注射用硫酸艾沙康唑药品注册证书的公告 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。 上述产品的获批进一步丰富了公司产品线，为临床用药提供更多选择。 药品名称：注射用硫酸艾沙康唑 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）递交注射用硫酸艾 沙康唑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》，审评结论为批准 1 剂型：注射剂 规格：0.2g（按C22H17F2N5OS计） 药品分类：处方药 ...

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》 ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the market launch of Eicosapentaenoic Acid Ethyl Ester as a chemical raw material drug [1] Group 1 - The application for the domestic production of Eicosapentaenoic Acid Ethyl Ester was submitted in June 2023 and was accepted [1] - The approval notification was granted in May 2025, with a review conclusion of registration approval [1]

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% ...

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>> ...

Group 1: Company Strategy and Focus Areas - The company aims to focus on the aging population by developing key drug bases, including analgesics, hormone raw materials, and cardiovascular/metabolic drugs, while accelerating the progress of major innovative drugs like OAB-14 for Alzheimer's treatment [2] - The company has set a goal to build a century-old enterprise with three world-class production bases, emphasizing the safety chain in the Chinese pharmaceutical market [3] Group 2: Financial Performance and Market Position - In 2024, the company's sales to the Americas accounted for 10.88% of total revenue, with sales to the U.S. specifically making up about 4% [2] - The company has approximately 300-400 drug production approvals, with an estimated one-third being outsourced, leading to concerns about the market viability of many products due to low average sales [3][4] Group 3: Production Capacity and Efficiency - The actual production capacity utilization rate is only 30%, suggesting that even with significant sales growth, the current production lines may become obsolete [2] - The company is focusing on enhancing research and development efficiency and smart production transformation to build sustainable operational resilience [4] Group 4: Investor Relations and Market Confidence - The company plans to strengthen investor confidence through various means, including inviting institutional investors for site visits and holding analyst meetings [4] - The company has implemented a market value management plan and is committed to increasing cash dividends, which have exceeded the stipulated proportion in the company’s articles of association [4] Group 5: Challenges and Future Outlook - The company faces challenges with a significant drop in stock price, which has fallen to the 10-year average, and is perceived as weak compared to peers in the pharmaceutical sector [4] - The company is committed to improving its market image and value through strategic initiatives, including enhancing R&D investments and optimizing product structure [9]

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 | | | | --- | -- ...

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]

Financial Performance - The company's operating revenue for Q1 2025 was ¥2,429,825,335.81, a decrease of 1.81% compared to ¥2,474,697,457.66 in the same period last year[5] - Net profit attributable to shareholders was ¥112,095,257.24, down 20.99% from ¥141,879,437.62 year-on-year[5] - Basic and diluted earnings per share were both ¥0.15, representing a decline of 28.57% from ¥0.21 in the same period last year[5] - Total comprehensive income for the current period was 104,998,682.16, down from 146,079,426.17 in the previous period, a decrease of about 28.2%[20] - Net profit for the current period was 115,643,803.12, down from 145,264,098.40 in the previous period, representing a decrease of approximately 20.4%[19] Cash Flow and Operating Activities - The net cash flow from operating activities decreased by 77.87%, amounting to ¥8,425,190.10 compared to ¥38,063,364.43 in the previous year[5] - Cash flow from operating activities generated a net amount of 8,425,190.10, significantly lower than 38,063,364.43 in the previous period[21] - The decline in net cash flow from operating activities was attributed to an increase in the proportion of bank acceptance bill collections and a decrease in inventory changes compared to the previous year[8] Assets and Liabilities - Total assets at the end of the reporting period were ¥9,269,855,861.11, an increase of 2.77% from ¥9,019,601,567.53 at the end of the previous year[5] - The total current assets increased to ¥3,999,396,150.59 from ¥3,726,840,162.91, reflecting a growth of about 7.3%[16] - Accounts receivable rose significantly to ¥1,200,307,190.06, up from ¥868,204,001.79, indicating an increase of approximately 38.2%[16] - The total liabilities increased to ¥3,879,907,761.23 from ¥3,802,101,150.19, marking a rise of about 2.0%[17] - The non-current liabilities decreased to ¥645,097,935.77 from ¥1,006,487,037.80, a reduction of approximately 35.9%[17] Shareholder Equity - Shareholders' equity attributable to the parent company increased by 3.28% to ¥5,155,519,978.65 from ¥4,991,588,524.78[5] - The total equity attributable to shareholders increased to ¥5,155,519,978.65 from ¥4,991,588,524.78, indicating a growth of approximately 3.3%[17] Expenses - Research and development expenses for the current period were 109,788,595.18, compared to 141,905,763.44 in the previous period, showing a reduction of approximately 22.6%[19] - The company reported a decrease in sales expenses from 291,064,033.27 in the previous period to 99,952,491.15 in the current period, a reduction of about 65.6%[19] - The company's total operating costs decreased from 2,328,929,009.30 to 2,299,988,387.70, a reduction of approximately 1.2%[19] Other Income and Changes - The company reported non-operating income of ¥7,067,182.83, primarily from government subsidies and asset disposal gains[7] - The company approved changes to accounting policies that are not expected to have a significant impact on the financial statements[13] - The company experienced an investment loss of 760,243.82 in the current period, compared to a gain of 1,188,728.16 in the previous period[19]