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]

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 ...

山东新华制药股份有限公司： 本所受贵公司的委托，指派律师出席了贵公司 2024 年度周年股东大会（以 下称本次股东大会）。现根据《中华人民共和国公司法》（以下称《公司法》）、 《中华人民共和国证券法》（以下称《证券法》）、《上市公司股东会规则》（以 下称《股东会规则》）、《深圳证券交易所上市公司股东会网络投票实施细则》 （以下称《网络投票细则》）等有关法律、行政法规、规范性文件及贵公司章程 之规定，出具本法律意见书。 为出具本法律意见书，本所律师列席了本次股东大会并审查了贵公司提供的 本次股东大会有关文件的原件或影印件，包括（但不限于）本次股东大会各项议 程及相关决议等文件，同时听取了贵公司就有关事实的陈述和说明。贵公司已保 证和承诺，贵公司提供的文件和所作的陈述和说明是完整的、真实的和有效的， 有关原件及其上面的签字和印章是真实的，且一切足以影响本法律意见书的事实 和文件均已向本所披露，而无任何隐瞒、疏漏之处。 在本法律意见书中，本所律师仅根据本法律意见书出具日以前发生的事实及 基于本所律师对该事实的了解及对有关法律的理解发表法律意见。在本法律意见 书中，本所仅就本次股东大会涉及的法律问题发表意见。 本法律 ...

证券代码：000756 证券简称：新华制药 公告编号：2025-37 山东新华制药股份有限公司 2024年周年股东大会决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没有虚假记载、误导性陈述或 重大遗漏。 特别提示： 1、公司2024年周年股东大会（"周年股东大会"）没有否决议案的情形。 2、周年股东大会不涉及变更前次股东大会决议的情形。 一、会议召开的情况 1、召开时间： （1）现场会议召开时间：2025年6月13日下午二时 （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2025年6月13日上午9:15至下午15:00期间的任意时间。 2、现场会议召开地点：山东省淄博市高新区鲁泰大道1号本公司会议室 3、召开方式：现场投票和网络投票相结合的方式 4、召集人：本公司董事会 5、主持人：本公司董事长贺同庆先生 6、周年股东大会的召开符合《中华人民共和国公司法》、《深圳证券交易所上市公司股东大会网 络投票实施细则》和本公司 ...

Group 1 - Libet has received approval from the China Securities Regulatory Commission for the issuance of convertible bonds, valid for 12 months [1] - Dinglong plans to acquire an additional 8% stake in its subsidiary, increasing its ownership from 91.35% to 99.35% for a total price of 240 million yuan [1] - Longyuan Donggu has been designated as a supplier for a major automotive project, with an expected total sales amount of 450 to 500 million yuan over five years [14] Group 2 - Luoniushan reported a sales revenue of 100 million yuan in May, a year-on-year decrease of 11.45% [2] - Baoming Technology has secured a loan commitment of up to 7 million yuan for stock repurchase [2] - Xinhua Pharmaceutical has received approval for the listing of a new chemical raw material used in treating chronic heart failure and hypertension [3] Group 3 - China Minmetals announced a new contract amount of 396 billion yuan for the first five months of the year, a decrease of 22.2% year-on-year [7] - Zhongbei Communication's application for a specific stock issuance has been accepted by the Shanghai Stock Exchange [8] - Rongfa Nuclear Power plans to issue bonds not exceeding 1 billion yuan to repay debts and supplement working capital [9] Group 4 - Phoenix Optical plans to invest 8.5 million USD to establish a wholly-owned subsidiary in Vietnam for manufacturing optical products [11] - Xiamen Airport reported a passenger throughput of 2.4752 million in May, a year-on-year increase of 8.34% [12] - Weilan Biological has received a new veterinary drug registration certificate for a product aimed at treating canine allergies and inflammation [13] Group 5 - Shouxiangu has completed the registration of a health food product that claims to enhance immunity [13] - Xingye Yinxin's subsidiary has passed a resource reserve verification report, confirming significant mineral reserves [16] - Shaanxi Construction has won two major projects with a total contract value exceeding 2.8 billion yuan [18] Group 6 - Huari received a cash dividend of 50 million yuan from its subsidiary [20] - Zhongchu's deputy general manager has resigned due to governance arrangements [21] - Kexin Pharmaceutical's core product has received breakthrough therapy designation from the National Medical Products Administration [39]

证券代码：000756 证券简称：新华制药 公告编号：2025-36 山东新华制药股份有限公司 关于获得沙库巴曲缬沙坦钠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 局核准签发的沙库巴曲缬沙坦钠（"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：沙库巴曲缬沙坦钠 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 10 月，新华制药向国家药品监督管理局递交沙库巴曲缬沙坦钠境内生产化学原 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。 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 ...