近日，拓新药业集团股份有限公司（以下简称"公司"）全资子公司新乡制 药股份有限公司（以下简称"新乡制药"）胞磷胆碱原料药收到国家药品监督管 理局签发的《化学原料药上市申请批准通知书》（受理号：CYHS2360697），并 在国家药品监督管理局药品审评中心官方网站公示,现将相关情况公告如下： 一、 原料药登记信息 通用名称：胞磷胆碱 英文名/拉丁名：Citicoline 证券代码：301089 证券简称：拓新药业 公告编号：2025-032 拓新药业集团股份有限公司 关于全资子公司胞磷胆碱原料药 获得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的内容真实、准确、完整，没有虚假记载、误导 性陈述或者重大遗漏。 胞磷胆碱作为临床常用的神经保护剂与脑代谢激活剂，其核心药理作用在于 改善脑功能、促进神经修复，临床适用范围涵盖脑损伤、脑血管疾病、神经系统 退行性疾病等患者群体。该药品通过提高脑细胞能量代谢效率、稳定细胞膜结构、 1 加速受损神经组织修复等机制发挥作用，在脑卒中、脑外伤等疾病的辅助治疗中 具有重要临床价值。 化学原料药注册标准编号：YBY66352025 申请事项：境内生产化学原料药上市申请 ...

Core Viewpoint - The announcement details the completion of a share reduction plan by a significant shareholder of Tuoxin Pharmaceutical, indicating a decrease in the shareholding percentage of the controlling shareholder and its concerted parties, but clarifying that this will not impact the company's governance structure or control [1]. Group 1: Share Reduction Details - The concerted party, Yiwos Trading Co., Ltd., reduced its holdings by a total of 3,122,086 shares, representing 2.47% of the company's total share capital [1]. - The reduction occurred through two methods: 1,265,400 shares were sold via centralized bidding at an average price of 30.93 yuan per share from March 14 to May 19, and 1,856,686 shares were sold through block trading at an average price of 27.03 yuan per share from April 1 to June 6 [1][2]. - The overall average selling price for the shares reduced was 28.61 yuan per share, resulting in a total reduction amount of approximately 89.32 million yuan [1]. Group 2: Company Background and Financials - Tuoxin Pharmaceutical was listed on the Shenzhen Stock Exchange's Growth Enterprise Market on October 27, 2021, with an initial public offering of 31.5 million shares at a price of 19.11 yuan per share [2]. - The total funds raised from the initial public offering amounted to 602 million yuan, with a net amount of 543 million yuan after deducting issuance costs, exceeding the original plan by 148 million yuan [3]. - The funds raised are intended for projects including the construction of nucleoside series specialty raw materials and pharmaceutical intermediates, the establishment of the Tuoxin Pharmaceutical Research Institute, and to supplement working capital [3].

拓新药业集团股份有限公司 证券代码：301089 证券简称：拓新药业 公告编号：2025-031 关于公司控股股东、实际控制人之一致行动人减持计划实 施时间届满的公告 股东新乡市伊沃斯商贸有限公司保证向本公司提供的信息内容真实、准 确、完整，没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一 致。 拓新药业集团股份有限公司（以下简称"公司"）于2025年2月20日披露公 司控股股东、实际控制人杨西宁之一致行动人新乡市伊沃斯商贸有限公司（以 下简称"伊沃斯"）《关于公司股东减持计划预披露的公告》（公告编号： 2025-010）。 公司近日收到伊沃斯出具的《关于股份减持计划实施时间届满暨减持结果 的告知函》，截至2025年6月13日，伊沃斯通过集中竞价、大宗交易累计减持 3,122,086股，占公司总股本的2.47%。本次权益变动后，公司控股股东、实际 控制人杨西宁及其一致行动人伊沃斯合计持有公司股份占公司总股本的比例由 29.84%减少至27.37%，本次减持期间结束，现将有关情况公告如下： 一、股东减持情况 1、减持股份来源：公司首次公开发行前已发行的股份。 ...

证券代码：301089 证券简称：拓新药业 公告编号：2025-030 拓新药业集团股份有限公司 关于子公司药品生产许可证变更的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性 陈述或者重大遗漏。 拓新药业集团股份有限公司（以下简称"公司"）子公司新乡制药股份有限 公司（以下简称"新乡制药"）近日取得了河南省药品监督管理局颁发的《药品 生产许可证》。本次涉及变更的事项为：同意该企业增加生产范围：原料药：替 加氟（抗肿瘤药）、尿嘧啶（仅限注册申报使用）。生产车间和生产线：八车间 （23 号厂房 B 区+11 号厂房 E 区）、原料药（替加氟）生产线；十二车间（24 号厂房 B 区+11 号厂房 C 区）、原料药（尿嘧啶）生产线。本次变更涉及增加生 产范围，变更后的《药品生产许可证》具体内容如下： 一、《药品生产许可证》的基本信息 编号：豫 20150044 生产地址和生产范围： 新乡市高新区静泉西路398号：原料药（奥拉帕利），无菌原料药（单磷酸 阿糖腺苷）*** 新乡市延津县产业集聚区北区建文路 16 号：原料药（胞磷胆碱钠、环磷腺 苷、胞磷胆碱、利巴韦林、肌苷、阿昔洛韦、 ...

Core Viewpoint - The announcement details a significant share reduction by a major shareholder of Tuoxin Pharmaceutical, indicating a shift in ownership structure and potential implications for investor confidence [1][2]. Shareholding Changes - The controlling shareholder, Yang Xining, and his concerted action party, Yiwos Trading Co., Ltd., reduced their stake by 1,019,100 shares, representing 0.81% of the total share capital [1][2]. - Post-reduction, the combined shareholding of Yang Xining and Yiwos decreased from 28.80% to 27.99% [1]. Financial Performance - Tuoxin Pharmaceutical reported a revenue of 422 million yuan for the previous year, a decline of 49.53% year-on-year [2]. - The net profit attributable to shareholders was -19.88 million yuan, compared to a profit of 243 million yuan in the previous year [2]. - The net profit after deducting non-recurring gains and losses was -27.26 million yuan, down from 23.2 million yuan year-on-year [2]. - The net cash flow from operating activities was 103 million yuan, an increase of 280.91% year-on-year [2]. Recent Quarterly Results - In the first quarter of 2025, Tuoxin Pharmaceutical achieved a revenue of 96.99 million yuan, a decrease of 10.46% compared to the same period last year [3]. - The net profit attributable to shareholders was -3.56 million yuan, compared to a profit of 0.21 million yuan in the same quarter last year [3]. - The net cash flow from operating activities was 28.01 million yuan, a decline of 153.72% year-on-year [3]. Dividend Distribution - The board approved a profit distribution plan, proposing no cash dividends or stock bonuses for shareholders [3]. Initial Public Offering (IPO) Details - Tuoxin Pharmaceutical was listed on the Shenzhen Stock Exchange's Growth Enterprise Market on October 27, 2021, with an initial public offering of 31.5 million shares at a price of 19.11 yuan per share [3]. - The total funds raised amounted to 602 million yuan, with a net amount of 543 million yuan after deducting issuance costs [3][4]. - The funds were intended for projects related to nucleoside series specialty raw materials, pharmaceutical intermediates, and working capital [3].

Group 1 - The domestic "Viagra" (Sildenafil Citrate) is facing severe market stagnation, with companies like Baiyunshan and Kelun Pharmaceutical experiencing declining sales and increasing inventory [1][3][4] - A total of 91 different Sildenafil-based drugs have been approved in China, leading to intense price competition, with products like Qilu's "Qianwei" priced as low as 2.08 yuan per tablet [1][6][9] - A survey from Peking University and Fudan University indicates that only 50% of the post-95 generation engage in sexual activity weekly, contributing to the decline in demand for erectile dysfunction medications [1][13] Group 2 - The market for domestic "Viagra" is undergoing unprecedented challenges due to intensified competition, changing consumer perceptions, and societal trends [3][14] - Baiyunshan reported a significant drop in sales of its "Jin Ge" product, with daily sales decreasing by 36,000 tablets compared to the previous year, leading to a nearly 50% increase in inventory [4][5] - Other companies, such as Kelun Pharmaceutical and Tainkang, have also reported substantial declines in revenue and net profit, with Kelun's revenue dropping by 29.42% year-on-year in Q1 2025 [5][6][14] Group 3 - The surge in competing products has led to a "white-hot" market competition, with Baiyunshan attributing its inventory issues to the increasing number of competitors [6][9] - The aggressive pricing strategies of competitors, such as Qilu's "Qianwei," have significantly impacted the market share of established products like "Jin Ge" and even the original brand Viagra [9][11] - Changing health perceptions among consumers, with a shift towards non-drug methods for improving health, is further reshaping the market landscape [13][14]

证券代码：301089 证券简称：拓新药业 公告编号：2025-029 | | 至2025年5月30日，公司控股股东、实际控制人杨西宁及其一致行 动人伊沃斯合计持有公司股份占公司总股本的比例由28.80%减少 | | --- | --- | | | 至27.99%。 | | 本次变动是否存在违反《证券法》 | | | 《上市公司收购管理办法》等法律、 | 是□ 否☑ | | 行政法规、部门规章、规范性文件 | 如是，请说明违规的具体情况、整改计划和处理措施。 | | 和本所业务规则等规定的情况 | | | 5.被限制表决权的股份情况 | | | 按照《证券法》第六十三条的规定， | 是□ 否☑ | | 是否存在不得行使表决权的股份 | 如是，请说明对应股份数量占现有上市公司股本的比例。 | | 6.备查文件 | | | 1. 股东伊沃斯出具相关股份变动告知函 | | 注：合计数据尾差为四舍五入所致 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一 致。 拓新药业集团股份有限公司（以下简称"公司"）于2025年2月20日披露公 司控股股东、实际控制人杨西宁之一致行动人新乡市伊沃斯商贸有限公司（以下 ...

| | 本报告期 | 上年同期 | 本报告期比上年同期增减 | | --- | --- | --- | --- | | | | | (%) | | 营业收入(元) | 96, 994, 677. 03 | 108, 322, 506. 68 | -10. 46% | | 归属于上市公司股东的净利 润(元) | -3,564,740.69 | 2.068, 381. 83 | -272. 34% | | 归属于上市公司股东的扣除 非经常性损益的净利润 | -5.952.687.74 | -641. 436. 44 | -828. 02% | | (元) | | | | | 经营活动产生的现金流量净 额(元) | -28,010,536.70 | 52, 145, 490, 57 | -153. 72% | 拓新药业于2021年10月27日在深交所创业板上市，公开发行数量为3150万股，发行价格为19.11元/股， 保荐机构、主承销商为中天国富证券有限公司，保荐代表人为常江、彭德强。 拓新药业首次公开发行募集资金总额为6.02亿元，扣除发行费用后，实际募集资金净额为5.43亿元。拓 新药业最终募集资金净额比原计划 ...

Core Viewpoint - The A-share pharmaceutical sector is experiencing significant fluctuations, with notable declines in several companies' stock prices, indicating a broader market adjustment in this industry [1] Company Summary - Haichen Pharmaceutical has seen its stock price drop by over 10% [1] - Key competitors such as Keyuan Pharmaceutical and Tuoxin Pharmaceutical have also faced declines, with drops exceeding 8% [1] - Other companies in the sector, including Duori Pharmaceutical, Ruizhi Pharmaceutical, and Nuotai Biological, are also experiencing downward trends in their stock prices [1]

Investment Rating - The report maintains a positive outlook on the innovative drug sector within the healthcare industry [1]. Core Insights - The pharmaceutical sector outperformed the CSI 300 index slightly, with the Shenwan Pharmaceutical and Biological Index rising by 1.27% from May 12 to May 16, 2025, and by 2.48% year-to-date, ranking 11th among 31 Shenwan primary industry indices [1][12]. - The current valuation of the pharmaceutical sector stands at 26.80 times (TTM overall method, excluding negative values), with a premium of 141.06% compared to the CSI 300 index [15]. - The innovative drug segment is experiencing a pullback due to U.S. President Trump's announcement regarding drug price reductions, but the report suggests that the actual implementation of such policies will be challenging and will not significantly impact Chinese innovative drug companies' international expansion [3][20]. Summary by Sections 1. Market Review - The pharmaceutical sector's performance from May 12 to May 16, 2025, showed a 1.27% increase, outperforming the CSI 300 index by 0.15 percentage points [10]. - Year-to-date, the sector has increased by 2.48%, surpassing the CSI 300 index by 3.64 percentage points [12]. 2. Key Events - On May 12, 2025, President Trump announced plans to sign an executive order aimed at reducing prescription drug prices in the U.S., potentially lowering prices by 30% to 80% [19]. 3. Industry Perspective - The innovative drug sector is expected to continue as a key investment theme for 2025, with a focus on international expansion and emerging markets, particularly in companies like Kexing Pharmaceutical [4][21]. - The report highlights that the ongoing collection and procurement policies in various pharmaceutical fields are accelerating, with potential growth in segments like insulin and orthopedics [4][21].