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 ...

新华制药（000756）公告，全资子公司山东淄博新达制药有限公司收到国家药品监督管理局核准签发的 盐酸伊伐布雷定片《药品注册证书》。该药品适用于窦性心律且心率≥75次/分钟、伴有心脏收缩功能障 碍的NYHAⅡ~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。2024年中国城市公立医疗机构盐酸伊伐布雷定片销售额约3.5亿元。 ...

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]

Group 1: Regulatory and Industry News - The Financial Regulatory Bureau has issued a notice to the industry stating that the dividend levels of participating insurance must not engage in "involutionary" competition [3] - In the photovoltaic sector, a "production reduction order" is expected to be upgraded in the third quarter, with a 10% decrease in operating rates and low-price sales subject to audit [3] - A video conference was held by three departments to strengthen the safety management of new energy vehicles, emphasizing not to engage in "involutionary" competition and not to sacrifice product performance or quality for short-term cost reduction [3] Group 2: Company-Specific News - The Shenzhen Stock Exchange has included Heng Rui Pharmaceutical in the list of eligible securities for Hong Kong Stock Connect [3] - Sanhua Intelligent Control has set the offering price for its H-shares at HKD 22.53 per share [3] - Feifan Lingyue has acquired a total of 18.09 million shares of Li Ning [3] - Jin Jing New Energy has officially launched a global lithium battery recycling network platform in collaboration with Yiwei Lithium Energy [3] - Nanjing Panda Electronics is selling its ENC equity to optimize its asset structure [3] - HYPEBEAST reported an annual loss of HKD 21.031 million, transitioning from profit to loss year-on-year [3] - NIO is speculated to be seeking strategic investors for its chip business, although this remains unconfirmed [3] - OK Blockchain Chain expects its annual loss attributable to shareholders to be no more than HKD 20 million, narrowing year-on-year [3] - Huadian International Power has received approval from the China Securities Regulatory Commission for the registration of its infrastructure REIT [3] - Xunhe Group anticipates an annual net loss of approximately HKD 4 million to HKD 7 million, transitioning from profit to loss year-on-year [3] - Shandong Xinhua Pharmaceutical has completed the Phase II clinical trial for OAB-14, a treatment for mild to moderate Alzheimer's disease, with the first patient enrolled in China [3]

证券代码：000756 证券简称：新华制药 公告编号： 2025-38 山东新华制药股份有限公司 关于 OAB-14 干混悬剂完成Ⅱ期临床中国首例患者入组的公告 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。 二、药物的研究情况 诚如巨潮资讯网 2024 年 8 月 23 日公告编号为 2024-38 的本公司《关于 OAB-14 干混悬 剂临床试验的进展公告》，在目前试验条件下，OAB-14 干混悬剂在健康成年受试者中安全 性和耐受性良好，多次给药后人体内无明显蓄积。 OAB-14 干混悬剂Ⅱ期药物临床试验由首都医科大学宣武医院联合全国多中心共同参与， 于 2025 年 6 月 19 日完成 OAB-14Ⅱ期临床中国首例患者入组。 三、药物的其他情况 OAB-14 是新华制药与沈阳药科大学合作研制的具有自主知识产权的新化学结构创新药， 属于 1 类创新药，适应症拟定为轻至中度阿尔茨海默病（AD）。 2019 年本公司开始合作进行非临床研究，研究结果表明 OAB-14 能显著改善 APP/PS1 双 转基因 AD 模型小鼠学习记忆和社交活动等多种行为障碍。OA ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has announced the completion of patient enrollment for the first case in the Phase II clinical trial of OAB-14, a dry suspension for the treatment of mild to moderate Alzheimer's disease in China [1] Group 1: Company Information - OAB-14 is a novel chemical structure innovation drug developed by Xinhua Pharmaceutical in collaboration with Shenyang Pharmaceutical University, possessing independent intellectual property rights [1] - The Phase II clinical trial for OAB-14 is being conducted in collaboration with Xuanwu Hospital of Capital Medical University and multiple centers across the country [1] - The first patient enrollment in the clinical trial was completed on June 19, 2025 [1] Group 2: Industry Context - OAB-14 is classified as a Class 1 innovative drug, indicating its potential significance in the pharmaceutical industry for treating Alzheimer's disease [1]

Core Viewpoint - Shandong Lukang Pharmaceutical Co., Ltd. is preparing to issue A-shares to specific investors in 2024, with legal opinions provided by Beijing Tongshang Law Firm regarding potential competition with Xinhua Pharmaceutical and the implications for the company [1][2]. Group 1: Company Overview - Shandong Lukang Pharmaceutical primarily engages in the research, production, and sale of pharmaceutical products, including antibiotics, antidiabetic drugs, cardiovascular drugs, and more, with over 500 product specifications [3][4]. - Xinhua Pharmaceutical, also established in 1993, focuses on the development and sale of chemical raw materials and formulations, with a product range that includes analgesics and cardiovascular drugs [4][5]. Group 2: Competition Analysis - There is some overlap in the product offerings of Shandong Lukang Pharmaceutical and Xinhua Pharmaceutical; however, the main products, technologies, and customer bases are significantly different, indicating no substantial adverse impact from competition [6][7]. - The revenue and gross profit from overlapping products between the two companies are relatively low, with Xinhua's overlapping products accounting for 3.08% to 5.69% of Lukang's main business revenue during the reporting period [11][12]. Group 3: Commitment to Avoid Competition - The controlling shareholder, Hualu Group, has issued a commitment to avoid any competition that could adversely affect Shandong Lukang Pharmaceutical, ensuring that both companies operate independently [14][15]. - Hualu Group has established internal management systems to ensure compliance with the commitment to avoid competition, and there have been no violations reported [18][19]. Group 4: Fundraising and Project Impact - The fundraising projects, including the construction of a high-end formulation intelligent manufacturing workshop and new drug research, are aimed at expanding existing business operations and will not introduce new competition [13][14]. - The proposed projects are aligned with the company's current business scope and are expected to enhance production capacity without creating significant competitive overlap with Xinhua Pharmaceutical [13][14].

一间于 中华 人民 共 和国成 立的 中外 合 资股份 有限 公司 公 司 章 程 经公司于2025年6月13日召开的2024年周年股东大会 山东新华制药股份有限公司 1 第一条 本公司系依照《中华人民共和国公司法》（简称《公司法》）和 其他有关法律、行政法规成立的股份有限公司。 本公司 1993 年 9 月经山东省经济体制改革委员会以鲁体改生字 （1993）第 66 号文批准确认以定向募集方式设立，1996 年 8 月 经国家经济体制改革委员会以体改生字（1996）116 号文确认为 到香港发行股票并上市的股份有限公司。公司于 1998 年 11 月 20 日在淄博市工商行政管理局重新注册登记，取得公司营业执照。 公司统一社会信用代码：91370300164103727C 公司的发起人为：山东新华制药厂 第二条 根据《公司法》和《中国共产党章程》规定，公司设立中国共产 党的组织，建立党的工作机构，配备足够数量的党务工作人员， 保障党组织的工作经费。党组织在公司中发挥领导核心和政治核 心作用。 第三条 公司注册名称 中文全称为：山东新华制药股份有限公司 英文全称为：Shandong Xinhua Pharma ...