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山东新华制药股份(00719)获得沙库巴曲缬沙坦钠片《药品注册证书》
智通财经网· 2025-08-26 09:35
本品作为血管紧张素II拮抗剂的复方药物,属于《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》乙类品种。根据相关统计数据,2024年中国公立医疗机构沙库巴曲缬沙坦钠片销售额约为人 民币49亿元。 新华制药的沙库巴曲缬沙坦钠片于2025年8月取得药品注册证书,有利于丰富本公司心血管疾病治疗药 物,提升公司综合竞争优势。 智通财经APP讯,山东新华制药股份(00719)发布公告,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沙库巴曲缬沙坦钠片(以下简称"该产品")《药 品注册证书》。 沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭(NYHA Ⅱ-Ⅳ级,LVEF≤40%)成人患者,降低心 血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧 张素Ⅱ受体拮抗剂(ARB),与其他心力衰竭治疗药物合用。沙库巴曲缬沙坦钠片也可用于治疗原发性高 血压。 ...
新华制药:子公司获得克拉霉素干混悬剂《药品注册证书》
Xin Lang Cai Jing· 2025-08-26 09:32
Core Viewpoint - The announcement indicates that the company's subsidiary has received regulatory approval for a new drug, which is expected to enhance its product portfolio and market presence in the pharmaceutical industry [1] Group 1 - The full subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin dry suspension by the National Medical Products Administration [1] - Clarithromycin is indicated for the treatment of infections caused by pathogens sensitive to the drug, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [1]
山东新华制药股份(00719)获得米诺地尔搽剂《药品注册证书》
智通财经网· 2025-08-26 09:30
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Minoxidil lotion, which is expected to enhance the company's product portfolio and overall competitiveness [1] Company Summary - The Minoxidil lotion received its registration certificate, which is a significant milestone for the company [1] - The approval date for the Minoxidil lotion is set for August 2025, indicating a future expansion in product offerings [1] Industry Summary - The approval of new pharmaceutical products like Minoxidil lotion contributes to the diversification of product categories within the pharmaceutical industry [1] - Enhanced product offerings are likely to improve competitive positioning in the market [1]
山东新华制药股份公布中期业绩 归母净利为约2.24亿元 同比减少15.69%
Zhi Tong Cai Jing· 2025-08-26 09:29
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the market despite some growth in specific segments [1] Financial Performance - The company's operating revenue was approximately 4.639 billion yuan, a year-on-year decrease of 1.98% [1] - Net profit attributable to shareholders was about 224 million yuan, down 15.69% year-on-year [1] - Basic earnings per share stood at 0.32 yuan [1] Product Development and Market Position - The company launched 10 new formulation products in the first half of the year [1] - A total of 19 products across 25 specifications were awarded national procurement bids [1] - The formulation processing and export business maintained stable growth, with significant development in self-operated formulation exports [1] Production and Innovation - The company focused on cost reduction and leveraged its production advantages in key raw materials, resulting in increased production of 11 key raw materials such as ibuprofen and aspirin, thereby expanding market share [1] - Sales of specialty raw materials experienced rapid growth [1] - In the first half of the year, the company obtained 21 drug approvals, including 19 new formulation products and 2 raw material drug approvals [1] - The company initiated Phase II clinical work for a Class I innovative drug OAB-14 for Alzheimer's treatment [1] - The company received 18 authorized patents, including 8 invention patents [1] - One project was awarded the Shandong Province 2024 Science and Technology Progress Award, and another was included in the 2025 provincial major science and technology innovation project [1]
山东新华制药股份(00719.HK):上半年净利润为2.24亿元 同比减少15.69%
Ge Long Hui· 2025-08-26 09:29
格隆汇8月26日丨山东新华制药股份(00719.HK)发布公告,集团2025年半年度按《中国企业会计准则》 计算,实现营业收入为人民币46.39亿元,同比减少1.98%;归属于上市公司股东的净利润为人民币2.24 亿元,同比减少15.69%。公司董事会建议不派发2025年半年度股息,不送红股,不以公积金转增股 本。 ...
山东新华制药股份(00719.HK)获得米诺地尔搽剂《药品注册证书》
Ge Long Hui· 2025-08-26 09:29
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Minoxidil topical solution, which is intended for the treatment of male pattern baldness and alopecia areata [1] Company Summary - The company submitted the application for the marketing authorization of Minoxidil topical solution to the Center for Drug Evaluation (CDE) in October 2023, which was accepted [1] - The drug registration certificate was granted in August 2025, with the evaluation conclusion being approval for registration [1] Industry Summary - The estimated sales revenue for Minoxidil in public medical institutions in China is approximately RMB 2.36 billion in 2024 [1]
山东新华制药股份(00719)公布中期业绩 归母净利为约2.24亿元 同比减少15.69%
智通财经网· 2025-08-26 09:28
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the market despite some growth in specific areas [1] Financial Performance - The company's operating revenue was approximately 4.639 billion yuan, a year-on-year decrease of 1.98% [1] - Net profit attributable to shareholders was about 224 million yuan, down 15.69% year-on-year [1] - Basic earnings per share stood at 0.32 yuan [1] Product Development and Market Position - The company launched 10 new formulation products in the first half of the year [1] - A total of 19 products with 25 specifications were awarded national procurement bids by the end of the reporting period [1] - The formulation processing and export business maintained stable growth, with significant development in self-operated formulation exports [1] Raw Material Production and Innovation - The company leveraged its production advantages in key raw materials, achieving increased production of 11 key raw materials including ibuprofen and aspirin, thereby expanding market share [1] - Sales of specialty raw materials experienced rapid growth [1] - The company obtained 21 drug approvals in the first half of the year, including 19 new formulation products and 2 raw material drug approvals [1] - It initiated Phase II clinical trials for a Class 1 innovative drug OAB-14 for Alzheimer's treatment [1] - The company received 18 authorized patents, including 8 invention patents [1] Recognition and Future Projects - One project was awarded the Shandong Province 2024 Science and Technology Progress Second Prize [1] - Another project was included in the 2025 provincial major scientific and technological innovation engineering projects [1]
新华制药:“原料药+制剂”一体化发展
Da Zhong Ri Bao· 2025-08-17 00:50
Core Competitiveness - The company has established a complete industrial chain for ibuprofen, from key intermediates to active pharmaceutical ingredients (APIs) and finished dosage forms, with an API annual production capacity accounting for nearly 40% of global total capacity, making it the largest single production base globally [1][2] - Founded in 1943, the company has evolved into a leader in the field of antipyretic and analgesic drugs, with an annual production capacity of 50,000 tons for chemical APIs, 500,000 tons for intermediates, 32 billion solid dosage forms, and 1.5 billion injection doses [1] Industry Leadership in Ibuprofen - The company has built an integrated strategy of "API + formulation," with a domestic market share of 45.14% in 2022 and export volume accounting for two-thirds of its annual production [2] - The ibuprofen API has received EU COS certification and passed FDA certification, reinforcing its position in the global market [2] Technological Innovation - Continuous breakthroughs in technology have led to the development of new synthetic processes, which won the first prize in the Shandong Provincial Science and Technology Progress Award in 2023, reducing reaction time by 40% and lowering energy consumption by 25% compared to industry averages [4] - The company holds 13 invention patents, establishing technological barriers, including customized crystal form control technology to produce special particle size products based on different dosage form requirements [4] Quality Control Standards - The company implements stringent internal control standards that exceed pharmacopoeia requirements, with impurity limits for ibuprofen set at 0.05% compared to the USP standard of 0.3% [5] - The entire production system complies with GMP standards in China, Europe, and the US, making the company a core supplier for major ibuprofen formulation manufacturers [5] Product Line Expansion - The company is expanding its formulation product line, with plans to launch ibuprofen suspension in 2023, sustained-release capsules in 2024, and other formulations by 2025, covering a full lifecycle dosage form matrix [5] - The company is pursuing dual-track strategies in the domestic market through national procurement and refined retail terminal招商, while also expanding into international markets [5] Research and Development Focus - Since the "14th Five-Year Plan," the company has focused on key areas such as cardiovascular, digestive system, and anti-tumor drugs, increasing R&D investment and achieving significant progress in innovative drugs [8] - The company has obtained 81 drug registration approvals, 27 consistency evaluation approvals for generic drugs, and 40 authorized invention patents [8] New Business Ventures - The company is actively advancing its "Internet + health" strategy, collaborating with JD.com and local health authorities to build a medical information platform and offering a one-stop internet healthcare solution [9] - It has launched high-purity fish oil health products and is entering the functional health beverage market with a new vitamin energy drink [9]
新华制药(000756)8月15日主力资金净流出1941.19万元
Sou Hu Cai Jing· 2025-08-15 11:48
通过天眼查大数据分析,山东新华制药股份有限公司共对外投资了19家企业,参与招投标项目5000次, 知识产权方面有商标信息402条,专利信息524条,此外企业还拥有行政许可855个。 来源:金融界 新华制药最新一期业绩显示,截至2025一季报,公司营业总收入24.30亿元、同比减少1.81%,归属净利 润1.12亿元,同比减少20.99%,扣非净利润1.05亿元,同比减少23.74%,流动比率1.236、速动比率 0.872、资产负债率41.86%。 天眼查商业履历信息显示,山东新华制药股份有限公司,成立于1998年,位于淄博市,是一家以从事医 药制造业为主的企业。企业注册资本689776.535万人民币,实缴资本68240.7635万人民币。公司法定代 表人为贺同庆。 金融界消息 截至2025年8月15日收盘,新华制药(000756)报收于16.44元,上涨1.11%,换手率 2.24%,成交量11.05万手,成交金额1.81亿元。 资金流向方面,今日主力资金净流出1941.19万元,占比成交额10.74%。其中,超大单净流出1021.86万 元、占成交额5.66%,大单净流出919.33万元、占成交额5.0 ...
新华制药(000756)8月14日主力资金净流出4119.96万元
Sou Hu Cai Jing· 2025-08-14 15:20
金融界消息 截至2025年8月14日收盘,新华制药(000756)报收于16.26元,下跌2.22%,换手率 2.72%,成交量13.41万手,成交金额2.20亿元。 资金流向方面,今日主力资金净流出4119.96万元,占比成交额18.7%。其中,超大单净流出2607.20万 元、占成交额11.84%,大单净流出1512.77万元、占成交额6.87%,中单净流出流入747.13万元、占成交 额3.39%,小单净流入3372.84万元、占成交额15.31%。 新华制药最新一期业绩显示,截至2025一季报,公司营业总收入24.30亿元、同比减少1.81%,归属净利 润1.12亿元,同比减少20.99%,扣非净利润1.05亿元,同比减少23.74%,流动比率1.236、速动比率 0.872、资产负债率41.86%。 天眼查商业履历信息显示,山东新华制药股份有限公司,成立于1998年,位于淄博市,是一家以从事医 药制造业为主的企业。企业注册资本689776.535万人民币,实缴资本68240.7635万人民币。公司法定代 表人为贺同庆。 通过天眼查大数据分析,山东新华制药股份有限公司共对外投资了19家企业,参与招投标 ...