登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：000403 证券简称：派林生物 公告编号：2026-002 药物名称：人凝血因子IX 剂型：注射剂 规格：500IU/瓶，复溶后10ml 申请事项：境内生产药品注册上市许可 申请人：广东双林生物制药有限公司 派斯双林生物制药股份有限公司 关于全资子公司获得药品注册上市许可受理通知书的公告 本公司及董事会全体成员保证信息披露的内容的真实、准确和完整，没有虚假记载、误导性陈述或者重 大遗漏。 近日，派斯双林生物制药股份有限公司（以下简称"公司"）之全资子公司广东双林生物制药有限公司 （以下简称"广东双林"）收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通 知书》（受理号：XCSS2600002），现将有关情况公告如下： 一、药品基本情况 五、风险提示 公司已获得人凝血因子IX药品注册上市许可《受理通知书》，具体审批完成时间尚不确定，公司将按 照国家有关规定，积极推进上述研发项目，将根据后续进展情况及时履行信息披露义务，敬请广大投资 者注意投资风险。 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定予以受理。 ...

北京商报讯(记者王寅浩宋雨盈)2月4日，派林生物（000403）发布公告称，公司全资子公司广东双林生 物制药有限公司收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知 书》。根据公告，人凝血因子IX适应症为：对于治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因 其它原因引起的人凝血因子Ⅸ含量低下的患者，可显著提升其血液中人凝血因子Ⅸ的水平，从而达到预 防和治疗出血的目的。 ...

派林生物（000403）(000403.SZ)公告，公司全资子公司广东双林生物制药有限公司(称"广东双林")收到 国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知书》。 ...

智通财经APP讯，派林生物(000403.SZ)公告，公司全资子公司广东双林生物制药有限公司(称"广东双 林")收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知书》。 ...

格隆汇2月4日丨派林生物(000403.SZ)公布，全资子公司广东双林生物制药有限公司（简称"广东双林"） 收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知书》。人凝血因子IX 适应症：对于治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因其它原因引起的人凝血因子Ⅸ含量低 下的患者，可显著提升其血液中人凝血因子Ⅸ的水平，从而达到预防和治疗出血的目的。乙型血友病属 罕见病，长期临床用药紧缺，现有治疗用药活性回收率待提升。公司长期以患者为中心，将致力于研发 高回收率的血源性药品。 ...

派林生物公告，近日，全资子公司广东双林生物制药有限公司收到国家药品监督管理局核准签发的人凝 血因子IX药品注册上市许可《受理通知书》（受理号：XCSS2600002）。人凝血因子IX适应症：对于 治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因其它原因引起的人凝血因子Ⅸ含量低下的患者，可 显著提升其血液中人凝血因子Ⅸ的水平，从而达到预防和治疗出血的目的。 ...

Core Viewpoint - The company has decided to terminate the development of prothrombin complex concentrate and shift focus to the more advantageous development of human coagulation factor IX, due to market demand, competitive landscape, and cost-effectiveness considerations [1][2]. Market Demand and Competitive Landscape - The domestic market for prothrombin complex concentrate has seen stable issuance volumes with limited new market space, while the market for human factor IX has fewer competitors and significant growth potential [1]. - Human factor IX is considered a better option for treating hemophilia B due to its lower risk of thrombotic side effects compared to prothrombin complex concentrate [1][2]. Product Comparison Analysis - Prothrombin complex concentrate contains various vitamin K-dependent factors and may pose risks of thrombosis with repeated high-dose use, while human factor IX is purer and has a higher specific activity, making it a safer treatment option [1][2]. Cost-Effectiveness Analysis - The clinical trial approval for prothrombin complex concentrate was obtained in 2008, but the regulatory requirements for production site changes and the need for extensive research have made it less economically viable compared to human factor IX, which has a higher sales price and greater market growth potential [2][4]. Project Background and Investment Plan - The genomic DNA length of human factor IX is approximately 34,000 bp, and the project is expected to complete development and obtain production approval by the end of 2030 [2][4]. - The estimated investment for the development of human factor IX is 60 million yuan, with funding sourced from both raised capital and the company's own funds [4]. Project Benefits and Feasibility - The human factor IX product is aimed at treating patients with factor IX deficiency (hemophilia B), and the limited number of competitors in this market suggests significant future growth opportunities [5]. - The project aligns with market trends and the company's operational needs, enhancing resource allocation and economic benefits, thereby improving profitability and market competitiveness [5][7]. Implementation Timeline - The implementation timeline for the new product development is expected to be completed by the end of 2030, with the associated production line construction already finished [6][4]. Impact of Changes on the Company - The termination of the prothrombin complex concentrate project will reduce the current year's net profit but is expected to enhance the company's future product development and sales capabilities [7]. - The board and supervisory committee have approved the change in fundraising purposes, emphasizing the alignment with the company's operational needs and long-term interests [8][10].

Core Viewpoint - The company has announced changes regarding its financial reporting and the use of raised funds, including the appointment of new auditors and the reallocation of surplus funds to enhance operational efficiency [6][34][46]. Financial Reporting - The board and management have confirmed the accuracy and completeness of the quarterly report, which has not been audited [2][3]. - The company has not made any retrospective adjustments or restatements to previous accounting data [3]. Auditor Changes - The company has appointed new signing auditors from KPMG Huazhen due to internal adjustments, with the new auditors being Wang Pu and Li Bingman [6][7]. Shareholder Meeting - The company will hold its third extraordinary general meeting on November 13, 2025, to discuss various proposals, including the reallocation of surplus funds [12][13][14]. Fund Utilization - The company plans to permanently supplement its working capital with surplus funds from completed projects, totaling approximately 27.62 million yuan [34][39]. - The surplus funds are primarily due to lower-than-expected transaction costs and effective cash management [37][38]. Project Changes - The company has revised the use of raised funds for new product development, shifting focus from the development of prothrombin complex to factor IX, while maintaining the overall budget for the project at 340.5 million yuan [46][47].