XINHUA PHARM(000756)
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新华制药:获得沙库巴曲缬沙坦钠化学原料药上市申请批准
news flash· 2025-06-11 08:38
Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of Sacubitril/Valsartan Sodium, which is indicated for adult patients with heart failure with reduced ejection fraction, aimed at reducing the risk of cardiovascular death and hospitalization due to heart failure [1] Company Summary - The approved drug, Sacubitril/Valsartan Sodium tablets, is specifically for adult patients suffering from chronic heart failure with reduced ejection fraction [1] - The anticipated sales revenue for Sacubitril/Valsartan Sodium tablets in Chinese public medical institutions is approximately RMB 4.9 billion in 2024 [1]
今日184只个股突破半年线
Zheng Quan Shi Bao Wang· 2025-06-09 04:29
Market Overview - The Shanghai Composite Index closed at 3393.26 points, above the six-month moving average, with a change of 0.23% [1] - The total trading volume of A-shares reached 838.618 billion yuan [1] Stocks Breaking Six-Month Moving Average - A total of 184 A-shares have surpassed the six-month moving average today [1] - Notable stocks with significant deviation rates include: - Qitian Technology: 11.69% deviation, closing price 14.38 yuan, with a daily increase of 20.03% and turnover rate of 15.50% [1] - Haochen Medical: 8.62% deviation, closing price 3.12 yuan, with a daily increase of 9.86% and turnover rate of 6.44% [1] - Jinyinhai: 7.58% deviation, closing price 21.00 yuan, with a daily increase of 9.66% and turnover rate of 6.43% [1] Additional Stocks with Deviation Rates - Other stocks with notable performance include: - Guangyun Technology: 7.45% deviation, closing price 14.13 yuan, with a daily increase of 9.20% and turnover rate of 4.78% [1] - Yaowang Technology: 5.93% deviation, closing price 7.12 yuan, with a daily increase of 7.88% and turnover rate of 13.64% [1] - Nuotai Biotech: 5.91% deviation, closing price 55.37 yuan, with a daily increase of 10.36% and turnover rate of 5.58% [1] Summary of Other Stocks - Additional stocks with lower deviation rates that have just crossed the six-month moving average include: - Guangdong Hongtu: just above the six-month line [1] - Xinhe Shares: just above the six-month line [1] - Songjing Shares: just above the six-month line [1]
林武在淄博调研督导经济运行时强调 更好统筹高质量发展和高水平安全 推动经济社会平稳健康发展
Da Zhong Ri Bao· 2025-06-06 01:03
Group 1 - The core viewpoint emphasizes the need for high-quality development and safety in economic operations, focusing on investment expansion, foreign trade stabilization, and consumption promotion [1][2] - The provincial leadership is actively engaging with companies to understand their operational challenges and encourage confidence in development, transformation, and upgrading [1] - There is a strong emphasis on enhancing research and development investments and accelerating project construction to promote high-end, intelligent, and green industrial development [1][2] Group 2 - Continuous optimization of enterprise services and implementation of policies to support businesses in becoming larger, stronger, and better is highlighted [2] - A proactive approach to economic operation analysis is necessary, focusing on addressing difficulties in investment, foreign trade, consumption, and project construction [2] - The commitment to green, low-carbon, and high-quality development is reinforced, with a focus on improving environmental protection measures and capabilities [2]
新华制药(000756) - 关于取得注射用硫酸艾沙康唑药品注册证书的公告


2025-06-05 09:45
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 ...
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》 ...
国有资本投资运营公司系列研究之一:山东省级投资运营公司观察
Yuan Dong Zi Xin· 2025-05-23 12:14
1. Report Industry Investment Rating - No relevant content provided. 2. Core Viewpoints of the Report - The report analyzes Shandong provincial state - owned capital investment and operation companies from four dimensions: establishment background and process, positioning and consolidated business directions, assets and profitability, and outstanding bonds and bond valuations [2]. - Shandong provincial state - owned capital investment and operation companies' construction process can be divided into three stages: transferring state - owned capital to the provincial social security fund (2014 - 2017), introducing Shandong Guohui and transferring 20% of social security funds to it (2018 - 2020), and restructuring the social security fund council into Caixin Company and reorganizing the provincial investment and operation platforms (2020 - present) [2][8][9]. - These companies can be classified into five types according to their functions and business directions: state - owned capital operation companies, diversified industrial investment companies, focused industrial investment companies, financial investment companies, and policy - oriented investment companies [3][15]. - The asset scale of 12 provincial state - owned capital investment and operation companies in Shandong is significantly differentiated, and the asset structure varies greatly due to different functional positioning and business segments. Their profitability is good but has been under pressure in recent years [4][31][43]. - The outstanding bonds are mainly public bonds, and the scale is also significantly differentiated. Shandong Development, Shandong Guotou, Shandong Land, Shandong Steel Group, and Shandong High - speed have relatively low weighted ChinaBond valuation yields [5][52]. 3. Summary According to the Directory 3.1 Emergence: Establishment of Shandong Provincial Investment and Operation Companies - In 2013, the Third Plenary Session of the 18th Central Committee proposed to reform the state - owned capital authorization and operation system. Shandong Province launched a new round of state - owned enterprise reform [6]. - In 2014, Shandong issued the "26 Articles on Shandong State - owned Enterprise Reform", and in 2015, it passed the "1 + 5" documents, which jointly formed the top - level design for the construction of Shandong's state - owned investment and operation platforms [7]. - The construction process of Shandong provincial state - owned capital investment and operation companies has three stages: transferring state - owned capital to the social security fund, introducing Shandong Guohui, and restructuring and integrating platforms [2][8][9]. 3.2 Anchoring Direction: Company Positioning and Consolidated Business Directions - Companies are divided into five types: state - owned capital operation companies (e.g., Shandong Guotou), diversified industrial investment companies (e.g., Hualu Group, Lushang Group, Shandong Guohui), focused industrial investment companies (e.g., Shandong Energy, Shandong Gold, Shandong High - speed, Shandong Steel Group), financial investment companies (e.g., Luxin Group), and policy - oriented investment companies (e.g., Shandong Land, Shandong Development, Shandong Finance) [3][15]. - Each type of company has its own core business and development strategy. For example, Shandong Guotou focuses on IT business, Hualu Group on high - end chemical industry, and Luxin Group on financial services [19][20][23]. 3.3 Financial Perspective: Company Assets and Profitability 3.3.1 Asset Dimension - Asset scale is significantly differentiated, divided into four echelons. Shandong High - speed and Shandong Energy have over - trillion - yuan asset scales, while Shandong Development has the smallest scale [31]. - Asset composition varies. There are four types based on the consolidated statements: assets mainly formed by industrial subsidiaries' businesses, financial assets and long - term equity investments in financial subsidiaries, assets mainly formed by equity investments, and assets mainly formed by government - function infrastructure and its investment and financing services [32][34][35]. 3.3.2 Profitability Dimension - The overall profitability of 12 companies is good but has been under pressure in recent years. Since 2022, the overall revenue growth has slowed down, and the net profit has declined [43]. - In terms of revenue structure, 7 companies have more retained operating profits, 4 companies' profits mainly come from investment income, and Shandong Steel's investment income is an important source of profit due to industry downturn [44]. 3.4 Bond Market: Outstanding Bonds and Bond Valuation Overview - Outstanding bonds are mainly public bonds, and the scale is significantly differentiated. Shandong High - speed has the highest outstanding bond scale, while Shandong Development and Hualu Group have the smallest [52]. - Shandong Development, Shandong Guotou, Shandong Land, Shandong Steel Group, and Shandong High - speed have relatively low weighted ChinaBond valuation yields, less than 2% [52].
新华制药(000756) - 关于取得布洛芬混悬滴剂药品注册证书的公告


2025-05-22 09:01
证券代码:000756 证券简称:新华制药 公告编号:2025-33 山东新华制药股份有限公司 关于取得布洛芬混悬滴剂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。 近日,山东新华制药股份有限公司(以下简称"新华制药"或"本公司")收到国家药品监督管理 局核准签发的布洛芬混悬滴剂(15ml:0.6g,30ml:1.2g)(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:布洛芬混悬滴剂 剂型:口服混悬剂 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) 受理号:CYHS2303314、CYHS2303315 药品批准文号:国药准字 H20254094、国药准字H20254095 通知书编号:2025S01279、2025S01280 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。同意本品按(甲类)非处方药管理。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 ...
新华制药(000756) - 关于二十碳五烯酸乙酯获得化学原料药上市申请批准通知书的公告


2025-05-19 08:45
证券代码:000756 证券简称:新华制药 公告编号:2025-32 山东新华制药股份有限公司 关于二十碳五烯酸乙酯获得化学原料药上市申请批准通知书的公告 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。 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《化学原料药上市申请批准通知书》。现将相关情况公告如 下: 通知书编号:2025YS00375 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。质量标准、标签及生产工艺照所附执行。 二、 其他相关信息 一、基本情况 药品名称:二十碳五烯酸乙酯 剂型:原料药 注册分类:化学药品 申请人:山东新华制药股份有限公司 申请事项:境内生产化学原料药上市申请 受理号:CYHS2360419 登记号:Y20230000457 2023 年 6 月,新华制药向国家药品监督管理局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《化学原料药上市申请批准通知 书》,审评结论为 ...
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
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]
财经早报:巨额资金撤离美国金融市场 突然大反攻人民币1个月狂飙2500点!
Xin Lang Zheng Quan· 2025-05-19 00:15
Group 1: Mergers and Acquisitions - The new regulations for major asset restructuring of listed companies have been officially launched, indicating the full implementation of the "six measures for mergers and acquisitions" [2] - The revised management measures support cross-industry mergers that align with business logic, establish a phased payment mechanism for restructuring shares, and encourage private equity funds to participate in mergers and acquisitions [2] - The introduction of a simplified review process for eligible listed companies significantly shortens the review timeline and improves disclosure requirements [2] Group 2: Currency and Trade - The Chinese yuan has shown signs of appreciation, with the central bank setting the mid-price below 7.2 for the first time since early April, following positive developments in Sino-US trade talks [4] - The dollar index experienced a significant drop of 10%, while Asian currencies appreciated by 5% to 10%, indicating a potential shift towards "de-dollarization" [4][5] - The U.S. Treasury Secretary indicated that countries not engaging in sincere negotiations will receive tariff notifications, with tariffs reverting to levels seen on April 2 [3] Group 3: Financial Markets - In April, foreign investors made a record net inflow of 8.21 trillion yen (approximately 406.6 billion RMB) into Japanese stocks and long-term bonds, marking the largest monthly net inflow since 1996 [6] - The rapid growth of bond ETFs has been noted, with the total market size surpassing 260 billion RMB, reflecting a shift towards more stable investment tools amid increased market volatility [10][11] Group 4: Corporate Developments - The CEO of Novo Nordisk has been dismissed, impacting the company's stock price, which fell by 2.69% following the announcement [17] - The company reported a total revenue of 78.087 billion Danish kroner (approximately 11.216 billion USD) for Q1 2025, an 18% year-on-year increase, with a significant portion of revenue coming from the blockbuster drug semaglutide [17] Group 5: Market Dynamics - The A-share market showed resilience with the Shanghai Composite Index rising by 0.76% and the ChiNext Index increasing by 1.38% during the week [13] - In the Hong Kong market, major indices experienced declines, with the Hang Seng Index dropping by 0.46% amid disappointing quarterly earnings from large tech and financial stocks [14]