证券代码：301089 证券简称：拓新药业 公告编号：2026-004 拓新药业集团股份有限公司 2025年度业绩预告 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。 一、本期业绩预计情况 （一）业绩预告期间：2025年1月1日-2025年12月31日。 （二）业绩预告情况：预计净利润为负值。 本次业绩预告是公司财务管理中心初步测算的结果，尚未经审计机构审计。 具体财务数据以公司披露的2025年年度报告为准。公司将严格依照有关法律法规 的规定和要求，及时做好信息披露工作，敬请广大投资者谨慎决策，注意投资风 险。 二、与会计师事务所沟通情况 公司已就业绩预告有关事项与会计师事务所进行了预沟通，双方不存在分歧。 三、业绩变动原因说明 2025年度公司整体经营业绩出现下滑，主要受以下两方面因素影响： 1．市场环境影响：受部分原料药产品终端需求波动及市场价格下行的影响， 公司相关产品的销售收入规模及毛利率水平均出现一定程度下降，直接影响了公 司整体盈利表现。 2.经营发展布局影响：一方面，公司募投项目完成转固后，新增产能尚处于 逐步释放的爬坡阶段，导致单位固定成本较 ...

Core Viewpoint - The announcement by Tuoxin Pharmaceutical indicates that its subsidiary, Xinxiang Pharmaceutical, has successfully passed the GMP compliance inspections for its production facilities related to the active pharmaceutical ingredients (APIs) Olaparib and Cytidine. This compliance is expected to enhance product quality stability and production capacity, thereby supporting future business expansion [1]. Group 1: GMP Compliance - Xinxiang Pharmaceutical received two GMP compliance inspection notices from the Henan Provincial Drug Administration [1]. - The production lines for the APIs Olaparib (an anti-tumor drug) and Cytidine have met the relevant regulatory requirements [1]. - The successful GMP compliance will enable the company to better meet market demand for these pharmaceuticals [1]. Group 2: Market Impact - The API Cytidine is now ready for market sales, while Olaparib will be available after filing with the National Medical Products Administration due to a change of address [1]. - This compliance is expected to significantly boost the company's ability to ensure stable product quality and supply capacity [1].

证券日报网讯 1月20日，拓新药业发布公告称，公司全资子公司新乡制药股份有限公司近日收到河南省 药品监督管理局分别核发的两份《药品GMP符合性检查告知书》（编号：HNGMP26015、编号：豫 GMP202503049）。 （编辑 任世碧） ...

Core Viewpoint - The company has received two GMP compliance inspection notices from the Henan Provincial Drug Administration for its subsidiary, Xinxiang Pharmaceutical, indicating that its production facilities and management systems meet the required standards for drug production quality management [1] Group 1 - The subsidiary Xinxiang Pharmaceutical has successfully passed GMP compliance inspections for its production lines related to the active pharmaceutical ingredients (APIs) Olaparib (an anti-tumor drug) and Cytidine Diphosphate Choline [1]

Core Viewpoint - The company, Tuoxin Pharmaceutical (301089.SZ), announced that its wholly-owned subsidiary, Xinxiang Pharmaceutical Co., Ltd., has received two "Drug GMP Compliance Inspection Notification Letters" from the Henan Provincial Drug Administration, indicating that its production facilities and management systems meet the requirements of drug production quality management standards [1]. Group 1 - The subsidiary, Xinxiang Pharmaceutical, successfully passed the GMP compliance inspection for the production lines related to the active pharmaceutical ingredients (APIs) Olaparib (an anti-tumor drug) and Cytidine Diphosphate Choline [1]. - The approval signifies a critical step for the company in ensuring the quality and compliance of its pharmaceutical production processes [1]. - This development may enhance the company's market position and potential for future growth in the pharmaceutical sector [1].

Core Viewpoint - The company, Tuoxin Pharmaceutical (301089.SZ), has received two GMP compliance inspection notices from the Henan Provincial Drug Administration for its subsidiary, Xinxiang Pharmaceutical Co., Ltd, indicating that its production facilities meet the required quality management standards for drug production [1]. Group 1: GMP Compliance - Xinxiang Pharmaceutical's facilities for the active pharmaceutical ingredients (APIs) Olaparib (an anti-tumor drug) and Cytidine Diphosphate Choline have passed the GMP compliance inspection [1]. - The approval allows the API Cytidine Diphosphate Choline to be marketed immediately, while Olaparib will be available for sale after filing with the National Medical Products Administration due to a change of address [1]. Group 2: Business Impact - The successful GMP compliance will enhance the company's ability to ensure product quality stability and production supply capacity [1]. - This development is expected to better meet market demand for related drugs and significantly promote the company's future business expansion [1].

Core Viewpoint - The company, Tuoxin Pharmaceutical (301089.SZ), announced that its wholly-owned subsidiary, Xinxiang Pharmaceutical Co., Ltd., has received two GMP compliance inspection notices from the Henan Provincial Drug Administration, indicating that its production facilities meet the required quality management standards for drug production [1]. Group 1: GMP Compliance - Xinxiang Pharmaceutical's facilities for the active pharmaceutical ingredients (APIs) Olaparib (an anti-tumor drug) and Cytidine Diphosphate Choline have passed the GMP compliance inspection [1]. - The approval allows the API Cytidine Diphosphate Choline to be marketed immediately, while Olaparib will be available for sale after filing with the National Medical Products Administration due to a change of address [1]. Group 2: Business Implications - The successful GMP compliance will enhance the company's ability to ensure product quality stability and production supply capacity [1]. - This development is expected to better meet market demand for the relevant drugs and significantly promote the company's future business expansion [1].

拓新药业公告，全资子公司新乡制药股份有限公司近日收到河南省药品监督管理局分别核发的两份《药 品GMP符合性检查告知书》。编号为HNGMP26015的告知书显示，新乡制药的生产品种原料药（奥拉 帕利）（抗肿瘤药）的八车间（23号厂房B区及11号厂房E区）通过药品GMP符合性检查。编号为豫 GMP202503049的告知书显示，新乡制药的原料药（胞磷胆碱）的七车间（25号厂房及12号厂房C 区），胞磷胆碱生产线通过药品GMP符合性检查。 ...

证券代码：301089 证券简称：拓新药业 公告编号：2026-003 拓新药业集团股份有限公司 关于子公司收到药品GMP符合性检查告知书的公告 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。 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"）近日收到河南省药品监督管理局分别核发的 两份《药品 GMP 符合性检查告知书》（编号：HNGMP26015、编号：豫 GMP202503049）， 现将具体情况公告如下： 一、新取得的《药品 GMP 符合性检查告知书》具体信息 （一）编号为：HNGMP26015 的告知书 （二）编号为：豫 GMP202503049 的告知书 1.被检查单位名称：新乡制药股份有限公司 2.检查地址：新乡市延津县产业集聚区北区建文路 16 号 3.检查范围及相关车间、生产线：检查范围：原料药（胞磷胆碱）；车间、 生产线：七车间（25 号厂房及 12 号厂房 C 区），胞磷胆碱生产线 4.检查时间：2025 年 10 月 30 日-2025 年 11 月 2 日 1.被检查单位名称：新乡制药 ...

格隆汇1月19日丨拓新药业(301089.SZ)公布，公司控股股东、实际控制人杨西宁先生与股东伊沃斯此前 的一致行动关系，系基于杨西宁先生担任伊沃斯执行董事的职务背景，且其通过直接或间接持股方式对 伊沃斯形成控制关系而产生。除上述情形外，双方未签署过任何书面一致行动协议，亦未就公司股东权 利的行使达成过保持一致行动的相关约定。 因伊沃斯发生股份变动，杨西宁先生不再通过直接或间接方式持有伊沃斯股份，相应不再对伊沃斯构成 控制关系，不再担任伊沃斯执行董事职务，亦不在伊沃斯担任任何职务。目前，伊沃斯已完成相关工商 变更登记手续，并取得了市场监督管理局换发的《营业执照》。伊沃斯股东及新任管理层与公司控股股 东、实际控制人杨西宁不存在关联关系、一致行动关系或可能导致利益倾斜的其他关系。至此，公司控 股股东、实际控制人杨西宁先生与股东伊沃斯不再符合《上市公司收购管理办法》中关于一致行动人关 系的认定情形，双方一致行动关系正式解除。 ...