2026.01.21 乙肝病毒感染是全球重大的公共卫生问题，急性乙肝未经彻底治愈会发展为慢性乙肝，后者一旦没有得 到及时控制，这种疾病可能进展为肝硬化甚至肝癌，现有治疗药物还无法彻底实现慢性乙肝治愈。近年 来，一些正在开发的乙肝药物，已在试图朝着功能性治愈的方向努力。 对于这次撤回培集成干扰素α-2注射液乙肝适应证注册申请，凯因科技表示，根据国家药监局最新审评 建议，经审慎研究，公司决定主动撤回本次药品注册申请，并将根据国家药监局的有关要求，进一步补 充临床病例研究，根据情况再次提交注册申请。 本文字数：1306，阅读时长大约2分钟 作者 |第一财经 林志吟 凯因科技（688687.SH）的乙肝药物已在申请上市阶段了，公司却主动撤回药品注册申请，这导致公司 股价在1月21日上午暴跌11.78%，成今日上午A股市场股价跌幅最大的企业。 前一晚，凯因科技发布消息称，公司收到国家药监局核准签发的《药品注册申请终止通知书》，同意公 司撤回培集成干扰素α-2注射液（新增乙肝适应证）的药品注册申请。 培集成干扰素α-2注射液是凯因科技自主研发的新型长效干扰素，已于2018年获批用于治疗成人慢性丙 型肝炎。 2024年9月 ...

Core Viewpoint - The company, Kaiyin Technology, has voluntarily withdrawn its drug registration application for Pegylated Interferon α-2 Injection for the treatment of chronic hepatitis B, leading to a significant drop in its stock price by 11.78% on January 21, making it the largest decline in the A-share market that morning [3][6]. Group 1: Drug Development and Market Impact - Pegylated Interferon α-2 Injection is a novel long-acting interferon developed by the company, initially approved in 2018 for chronic hepatitis C treatment [3]. - The new application aimed to expand its use to chronic hepatitis B, with clinical research showing potential for functional cure, including over 20% of patients achieving HBsAg clearance [4][5]. - The withdrawal was based on the latest review suggestions from the National Medical Products Administration, and the company plans to supplement clinical case studies before resubmitting the application [5][6]. Group 2: Financial Implications - The company has fully recognized impairment losses related to the development expenses of the withdrawn application, reducing its profit by 111 million yuan for the fiscal year 2025 [6]. - This decision raised concerns among investors about the future of the drug's development in hepatitis B, although the company clarified that it has not abandoned the project and is acting cautiously [6].

这款药物是公司研发进展最快的一款乙肝药。 凯因科技是国内首家成功开发出丙肝高治愈率泛基因型全口服系列药物的企业，可覆盖中国丙型肝炎所 有主要基因型，实现了97%的高治愈率，打破了进口垄断。但随着市场上市的丙肝泛基因型治疗药物越 来越多，公司在丙肝领域面临的竞争越来越激烈。公司也转向聚焦以创新药为核心的乙肝功能性治愈药 物组合研发。在公司的乙肝药物研发管线中，培集成干扰素α-2注射液是研发进展最快的一款药物。 凯因科技这次不单单是撤回了注册申请，还对培集成干扰素α-2注射液（新增乙肝适应证）项目涉及的 相关开发支出全额计提资产减值准备，相应减少公司2025年度利润总额1.11亿元，这种做法让一些投资 者也无法理解，难道是意味着该药在乙肝上的研发彻底没有希望了？ 换言之，该药展现出乙肝功能性治愈的潜力。 凯因科技（688687.SH）的乙肝药物已在申请上市阶段了，公司却主动撤回药品注册申请，这导致公司 股价在1月21日上午暴跌11.78%，成今日上午A股市场股价跌幅最大的企业。 乙肝病毒感染是全球重大的公共卫生问题，急性乙肝未经彻底治愈会发展为慢性乙肝，后者一旦没有得 到及时控制，这种疾病可能进展为肝硬化甚至肝癌 ...

凯因科技对培集成干扰素α-2注射液（新增乙肝适应证）项目涉及的相关开发支出全额计提资产减值准 备，相应减少2025年度利润总额约1.11亿元。 2025年前三季度，凯因科技营业收入为9.27亿元，利润总额为1.31亿元。此次撤回药品注册申请预计将 对凯因科技2025年全年业绩产生较大影响。中经记者 晏国文 卢志坤 北京报道 【凯因科技撤回一药品注册申请 2025年利润减少1.11亿元】2026年1月20日，科创板上市公司凯因科技 （688687.SH）披露，撤回培集成干扰素α-2注射液（新增乙肝适应证）的药品注册申请。 培集成干扰素α-2注射液是一款已上市药品，适用于治疗成人慢性丙型肝炎（HCV），于2018年获得药 品注册批件和新药证书。 2024年9月，凯因科技对该药品新增申报适应证。此次撤回申请的是新增申报适应证。 凯因科技方面表示，根据国家药监局最新审评建议，经审慎研究，公司决定主动撤回本次药品注册申 请，并将根据国家药监局的有关要求，进一步补充临床病例研究，根据情况再次提交注册申请。 ...

培集成干扰素α-2注射液是一款已上市药品，适用于治疗成人慢性丙型肝炎（HCV），于2018年获得药 品注册批件和新药证书。 2024年9月，凯因科技对该药品新增申报适应证。此次撤回申请的是新增申报适应证。 凯因科技方面表示，根据国家药监局最新审评建议，经审慎研究，公司决定主动撤回本次药品注册申 请，并将根据国家药监局的有关要求，进一步补充临床病例研究，根据情况再次提交注册申请。 2026年1月20日，科创板上市公司凯因科技（688687.SH）披露，撤回培集成干扰素α-2注射液（新增乙 肝适应证）的药品注册申请。 凯因科技对培集成干扰素α-2注射液（新增乙肝适应证）项目涉及的相关开发支出全额计提资产减值准 备，相应减少2025年度利润总额约1.11亿元。 2025年前三季度，凯因科技营业收入为9.27亿元，利润总额为1.31亿元。此次撤回药品注册申请预计将 对凯因科技2025年全年业绩产生较大影响。 （文章来源：中国经营报） ...

Core Viewpoint - The company, Kaiyin Technology, has received approval from the National Medical Products Administration to withdraw its drug registration application for Pegylated Interferon α-2 Injection (new hepatitis B indication) [1] Group 1: Company Actions - The company has decided to withdraw the drug registration application based on a principle of prudence [1] - As a result of this decision, the company will fully recognize an asset impairment provision related to the development expenses of the Pegylated Interferon α-2 Injection project [1] Group 2: Financial Impact - The recognition of the asset impairment provision will lead to a reduction in the company's total profit for the year 2025 by 111 million yuan [1]

北京凯因科技股份有限公司 关于自愿披露撤回药品注册申请的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 北京凯因科技股份有限公司（以下简称"公司"）于近日收到国家药品监督 管理局（以下简称"国家药监局"）核准签发的《药品注册申请终止通知书》， 同意公司撤回培集成干扰素α-2注射液（新增乙肝适应症）的药品注册申请，现 将相关情况公告如下： 证券代码：688687 证券简称：凯因科技 公告编号：2026-001 审批意见：根据《药品注册管理办法》第八十九条及申请人提交的撤回申请， 同意本品注册申请的撤回，终止注册程序。 二、 药品介绍及研发情况 一、 药品基本情况 商品名：派益生® 通用名：培集成干扰素α-2注射液 规格：0.15mg/1.0ml/支 受理号：CXSS2400105 申请人：北京凯因科技股份有限公司 申请事项：境内生产药品注册上市许可 拟定新增适应症（或功能主治）：派益生®联合富马酸丙酚替诺福韦片（TAF） 用于治疗成人慢性乙型肝炎（HBV）优势人群。 培集成干扰素α-2注射液为公司自主研发的新型长效干扰 ...

Core Viewpoint - The company, Kaiyin Technology, has voluntarily withdrawn its drug registration application for Pegylated Interferon α-2 Injection (new hepatitis B indication) as approved by the National Medical Products Administration, and plans to resubmit after further clinical case studies [1] Group 1: Company Actions - The company received a termination notice for its drug registration application from the National Medical Products Administration [1] - The company will fully recognize asset impairment related to the project, reducing the total profit for 2025 by 111.3011 million yuan [1] - The withdrawal of the application will not affect existing product sales but will impact the operating performance for 2025 [1] Group 2: Industry Context - The company emphasizes the uncertainty associated with new drug development, urging investors to be aware of investment risks [1]

Core Viewpoint - The company, Kaiyin Technology (688687.SH), has received approval from the National Medical Products Administration to withdraw its drug registration application for the interferon α-2 injection with a new indication for hepatitis B [1] Group 1 - The company has decided to withdraw the drug registration application for the interferon α-2 injection, which was intended for a new indication related to hepatitis B [1] - The new indication proposed was for the use of Paiyisheng® in combination with Tenofovir Alafenamide (TAF) for the treatment of adult chronic hepatitis B (HBV) patients [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration to withdraw its drug registration application for Pegylated Interferon α-2 Injection (new hepatitis B indication) [1] Group 1 - The company has decided to withdraw the drug registration application based on a principle of prudence [1] - As a result of this decision, the company will fully recognize an asset impairment provision related to the project, which will reduce the company's total profit for the year 2025 by 111 million yuan [1]