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]

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 ...

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]

Core Viewpoint - The article discusses the current state and future trends of the active pharmaceutical ingredients (API) industry in China, highlighting the competitive landscape, market dynamics, and the impact of regulatory changes on production and supply chains [4][5][6]. Industry Chain Overview - The API industry chain includes upstream basic chemicals and agriculture, midstream API production through various methods, and downstream chemical formulation production [4][5]. - The production segment of APIs requires high technical standards and is influenced by fluctuations in raw material prices and changes in downstream market demand [5]. Supply Chain Characteristics - China's API supply chain is characterized by high regional concentration and strong scale, with major production bases in East China and parts of the Midwest [7]. - The country holds a global price influence in bulk raw materials, supporting the large-scale development of the API industry, although it faces structural issues such as environmental regulations and reliance on imports for high-end intermediates [7]. Competitive Landscape - As of 2023, there are 1,661 API manufacturers in China, with significant concentrations in Jiangsu and Zhejiang provinces [9]. - Major competitors in the domestic API market include companies like New Chemical, Tianyu Co., and Prolo Pharmaceutical, which hold substantial market shares [13][14]. Market Segmentation - The API market is segmented into bulk APIs, specialty generic APIs, and patented APIs, with each segment exhibiting different growth rates and competitive dynamics [21][22]. - The bulk API market is mature with stable demand, while specialty APIs are characterized by higher technical barriers and profit margins [21]. Market Trends - The bulk API market is projected to reach approximately 300 billion RMB in 2024, with over 60% of production destined for export [23]. - The patented API market is expected to grow rapidly, with a projected market size of 30 billion RMB by 2024, driven by increasing demand from international pharmaceutical companies [24]. Production and Export Dynamics - China's API production has been increasing, with a record output of 401,000 tons in December 2023, reflecting strong downstream demand [27]. - The export value of APIs reached 42.98 billion USD in 2024, with a year-on-year growth of 5.1%, indicating a recovery from previous declines [37][39]. Future Outlook - The API industry is transitioning from a volume-driven model to a value-driven approach, focusing on high-quality and diversified development [17]. - The competitive landscape is intensifying, with price wars becoming common as companies vie for market share, leading to a 12% decrease in average export prices in 2024 [56].

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]

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 ...