（以上内容为金融界基于公开消息，由程序或算法智能生成，不作为投资建议或交易依据。） 本文源自：金融界 资金流向方面，当日主力流入NaN万港元，流出NaN万港元，净流出4651.46万港元。 山东新华制药股份有限公司成立于1943年的胶东抗日根据地,是新中国第一家化学合成制药企业,是全球 重要的解热镇痛药生产和出口基地,国内重要的心脑血管类、抗感染类、神经系统类、甾体激素类药物 等生产企业。拥有化学原料药、医药制剂、医药中间体、电商业务四大业务板块,5个产业园区,14家子公 司。化学原料药年生产能力5万吨,医药中间体50万吨,固体制剂320亿片(粒),注射剂15亿支。拥有阿司匹 林、布洛芬、左旋多巴、乙氧苯柳胺、三苯双脒、马蔺子素、吡哌酸等26个市场占有率第一或独家品 种,年出口额近4亿美元,与罗氏、拜耳、百利高等200多家知名跨国企业建立了长期战略合作关系。企业 总资产83亿元,为全国制药工业百强企业、原料药出口五强企业、制剂出口十强企业。新华制药是H股、 A股上市公司,新华牌商标被国家商务部和山东省列为重点培育和发展的出口品牌。新华制药是国家高新 技术企业、国家火炬计划重点高新技术企业、国家火炬计划生物医药 ...

证券代码：000756 证券简称：新华制药 公告编号：2025-41 山东新华制药股份有限公司 关于获得精氨酸布洛芬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 局核准签发的精氨酸布洛芬（"本品"）《化学原料药上市申请批准通知书》。现将相关情况公 告如下： 一、基本情况 原料药名称：精氨酸布洛芬 申请人：山东新华制药股份有限公司 通知书编号：2025YS00509 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、包装标签及生产工艺照所附执行。 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 CDE 递交精氨酸布洛芬境内生产化学原 料药上市申请注册申报资料并获受理， 2025 年 6 月获得《化学原料药上市申请批准通知 书》，审评结论为批准注册。 精氨酸布洛芬主要用于牙痛、痛经、因创伤引起的疼痛（例如：运动性损伤）、关节和 韧带痛、背痛、头痛、神经痛以及流感 ...

近日，山东新华制药股份有限公司（"新华制药"或"本公司"）之全资子公司山东淄博新达 制药有限公司（"新达制药"）收到国家药品监督管理局核准签发的盐酸伊伐布雷定片（"本品"） 《药品注册证书》，批准本品注册。现将相关情况公告如下： 一、基本情况 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 证券代码：000756 证券简称：新华制药 公告编号：2025-42 山东新华制药股份有限公司 关于获得盐酸伊伐布雷定片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。 ~Ⅳ级慢性心力衰竭患者，与标准治疗包括 β-受体阻滞剂联合用药，或者用于禁忌或不能耐受 β- 受体阻滞剂治疗时。 本品已录入《国家基本药物目录》，属于《国家基本医疗保险、工伤保险和生育保险药品目 录(2024年)》乙类品种。根据有关统计数据，2024年中国城市公立医疗机构盐酸伊伐布雷定片销 售额约 ...

山东新华制药股份有限公司 关于获得《药品补充申请批准通知书》等相关情况的公告 证券代码：000756 证券简称：新华制药 公告编号：2025-40 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马来酸阿伐曲泊帕片（以下简称"本品"）《药品补充申请批准通知 书》，批准本品上市许可持有人转让补充申请。现将相关情况公告如下： 一、基本情况 药品名称：马来酸阿伐曲泊帕片 剂型：片剂 规格：20mg（按 C₂₉H₃₄Cl₂N₆O₃S₂计） 药品分类：处方药 申请人：山东新华制药股份有限公司 申请事项：上市许可持有人变更申请 受理号：CYHB2501163 原药品批准文号：国药准字H20249585 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，本品此次申请事 项符合药品注册的有关要求，同意按照《药品上市后变更管理办法（试行）》相关规定，批 准本品上市许可持有人变更。 二、其他相关信息 新华制药与上海迪赛诺医药集团股份有限公司（以下简称"上海迪赛诺"）于2 ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the registration certificate of Ivabradine Hydrochloride Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The full subsidiary Shandong Zibo Xinda Pharmaceutical Co., Ltd. has been granted the drug registration certificate for Ivabradine Hydrochloride Tablets [1] - This medication is indicated for patients with chronic heart failure of NYHA II-IV class, who have sinus rhythm and a heart rate of ≥75 beats per minute, and is to be used in conjunction with standard treatments including beta-blockers or when beta-blockers are contraindicated or not tolerated [1] Group 2: Market Potential - The estimated sales revenue for Ivabradine Hydrochloride Tablets in urban public medical institutions in China is approximately 350 million yuan in 2024 [1]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the market launch of arginine ibuprofen, which is primarily used for alleviating pain symptoms such as toothache and dysmenorrhea [1] Company Summary - The newly approved product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for arginine ibuprofen formulations in Chinese public medical institutions is approximately 114 million yuan in 2024 [1] - The approval of this product is expected to enhance the company's product line and improve its core competitiveness [1] Industry Summary - The approval of arginine ibuprofen aligns with the growing demand for pain relief medications in the healthcare sector [1] - The inclusion of this product in the national insurance catalog may increase its accessibility and market penetration [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-39 山东新华制药股份有限公司 关于获得《药品补充申请批准通知书》等相关情况的公告 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腺苷钴胺胶囊（以下简称"本品"）《药品补充申请批准通知书》， 批准本品上市许可持有人转让补充申请。现将相关情况公告如下： 一、基本情况 药品名称：腺苷钴胺胶囊 剂型：胶囊剂 规格：0.5mg 药品分类：处方药 申请人：山东新华制药股份有限公司 申请事项：上市许可持有人变更申请 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，本品此次申请事 项符合药品注册的有关要求，同意按照《药品上市后变更管理办法（试行）》相关规定，批 准本品上市许可持有人变更。 二、其他相关信息 新华制药与北京柏雅联合药物研究所有限公司（以下简称"北京柏雅"）于2024年9月签 订了生产技术及MAH转让合同，合同约定：北京柏雅将拟取得的腺苷钴胺胶囊上市许可持有 人及所涉及的技术权属（生产 ...

Core Viewpoint - The company XinHua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the supplemental application of Adenosylcobalamin capsules, allowing the transfer of the marketing authorization holder [1] Group 1: Regulatory Approval - The approval notification allows the company to transfer the supplemental application without the need for board or shareholder meeting reviews, in accordance with the Shenzhen Stock Exchange listing rules and the company's articles of association [1] - The transaction does not constitute a related party transaction or a major asset restructuring as defined by the regulations [1] Group 2: Product Indications - Adenosylcobalamin capsules are primarily indicated for the treatment of megaloblastic anemia, nutritional anemia, anemia during pregnancy, multiple neuritis, radiculitis, trigeminal neuralgia, sciatica, and nerve paralysis [1] - The product can also be used as an adjunctive treatment for nutritional disorders and leukopenia caused by radiation and drugs [1]

据了解,"十四五"以来,该公司投入研发经费超17亿元,累计获得药品注册批件90项,仿制药一致性评价24 项,主持或参与制定国家药品标准57项,取得专利113项,获得省部级以上科技奖励8项,新增3个创新平台,各 类创新成果均超以往同期两倍以上。治疗阿尔茨海默症的重大创新药进入Ⅱ期临床,治疗痛风的 LXH2301进入三期临床…… 不仅如此,通过柔性引才、校园招聘、人才合作等方式,新华制药已汇聚起了一支包括10名院士、6名国家 重点人才工程专家、6名外国专家、16名泰山产业领军人才以及500余名硕士、博士等组成的高端创新人 才队伍。同时,该公司与中南大学、中国药科大学、沈阳药科大学等高校共建研发平台。建立科研创新 全生命周期激励机制,设立科技创新"绿色通道",对推进重磅创新药物、重大创新产品、重大创新技术、 重大创新资源等重大创新成果落地实施重奖。通过一系列创新成效,为该公司"十五五"高质量发展注入 强劲动能。 (扈艳华) 原料药的竞争核心,实际上是生物合成法逐步替代传统化学合成工艺的竞争。 近年来,新华制药联合山东省药学科学院、厦门大学等科研院所和高校,通过不断的技术创新和工艺改进, 攻克了一道道技术难题,解决了 ...

Company Overview - Shandong Lukang Pharmaceutical Co., Ltd. was established on February 15, 1993, and is located at 88 Deyuan Road, Jining High-tech Zone, Shandong Province [18] - The company is listed on the Shanghai Stock Exchange with the stock code 600789, and its actual controller is the State-owned Assets Supervision and Administration Commission of the Shandong Provincial Government [18][19] - As of December 31, 2024, the total share capital of the company is 898,669,632 shares, with 100% being unrestricted shares [19] Issuance Plan - The company plans to issue shares to no more than 35 specific investors, including its controlling shareholder, Hualu Group, which intends to subscribe for 23.81% of the shares, amounting to no more than 64,201,417 shares [2][3][6] - The total amount of funds raised from this issuance is not expected to exceed 1.2 billion yuan (120,000 million yuan) [8] - The final issuance price will be determined based on the average trading price of the company's shares over the 20 trading days prior to the pricing benchmark date, with a minimum price set at 80% of this average [4][5] Industry Context - The global chemical pharmaceuticals market has shown stable growth, increasing from USD 924.8 billion in 2016 to USD 1,104.7 billion in 2022 [20] - The Chinese chemical pharmaceuticals market reached a scale of 801.2 billion yuan in 2016, experiencing fluctuations due to global public health events but is expected to recover starting in 2023 [20] - Chronic diseases, particularly cardiovascular diseases and diabetes, are key focus areas for the company, with significant patient populations and high medical costs associated with these conditions [21][20] Market Trends - The market for cardiovascular drugs in China has maintained growth from 2015 to 2019, with fluctuations from 2020 to 2022 due to public health events [21] - The market for type 2 diabetes treatment drugs in China has experienced volatility from 2018 to 2022 but is projected to grow steadily due to the introduction of innovative diabetes medications and increased awareness of comprehensive health management [21] - The antibiotic market in China has grown from 145 billion yuan in 2016 to 208 billion yuan in 2023, despite regulatory restrictions on antibiotic use [22]