Core Viewpoint - The company Kain Technology (688687.SH) has voluntarily withdrawn its drug registration application for a hepatitis B treatment, leading to a significant drop in its stock price by 11.78% on January 21, making it the largest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 day [2][3]. Group 1: Drug Development and Regulatory Actions - Kain Technology received a termination notice from the National Medical Products Administration (NMPA) regarding its application for the drug Peginterferon α-2 Injection for a new hepatitis B indication [2]. - The drug Peginterferon α-2 Injection was initially approved in 2018 for treating chronic hepatitis C and was being studied for its efficacy in treating chronic hepatitis B, with clinical trials showing potential for functional cure [3]. - The company plans to supplement clinical case studies as per NMPA's requirements and intends to resubmit the registration application in the future, although no specific timeline has been provided [4]. Group 2: Financial Implications and Market Reaction - The withdrawal of the drug application has led the company to fully provision for asset impairment related to the development costs of the hepatitis B indication, which is expected to reduce the company's profit by 111 million yuan in 2025 [4]. - This decision has raised concerns among investors about the future of the drug's development in the hepatitis B space, although the company clarified that it has not abandoned the project and is acting out of caution [4].

Core Viewpoint - The company, Kaiyin Technology, has voluntarily withdrawn its drug registration application for Pegylated Interferon α-2 Injection for the treatment of chronic hepatitis B, leading to a significant drop in its stock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].

Core Viewpoint - The company has withdrawn its drug registration application for the hepatitis B treatment, leading to a significant drop in its stock price, indicating investor concerns about the future of its drug development pipeline [1][2][3] Group 1: Drug Development and Regulatory Actions - The drug in question, Peginterferon α-2a injection, was the fastest progressing hepatitis B drug in the company's pipeline and had recently reached the application stage for market approval [1] - The company received a termination notice from the National Medical Products Administration, agreeing to the withdrawal of the drug registration application for the hepatitis B indication [1][2] - The company plans to supplement clinical case studies as per regulatory requirements and may resubmit the registration application in the future [2][3] Group 2: Financial Impact and Market Reaction - The withdrawal of the registration application resulted in an 11.78% drop in the company's stock price, making it the largest decline in the A-share market on that day [1] - The company has fully recognized impairment losses related to the development expenses of the Peginterferon α-2a injection project, which will reduce its profit by 111 million yuan in 2025 [3] - This decision has raised concerns among investors about the viability of the drug's development for hepatitis B, although the company maintains that it has not abandoned the project [3] Group 3: Industry Context - Hepatitis B virus infection is a significant global public health issue, with chronic hepatitis B potentially leading to severe complications like cirrhosis and liver cancer if not properly managed [2] - The company has previously achieved a high cure rate for hepatitis C with its all-oral drug series, but faces increasing competition in the hepatitis C market, prompting a shift towards innovative hepatitis B treatments [2]

Core Viewpoint - Kaiyin Technology has withdrawn its drug registration application for Peginterferon α-2 Injection (new hepatitis B indication), which is expected to reduce its profit by approximately 111 million yuan in 2025 [1] Group 1: Company Actions - On January 20, 2026, Kaiyin Technology (688687.SH) announced the withdrawal of its drug registration application for Peginterferon α-2 Injection, which is already approved for treating chronic hepatitis C [1] - The company decided to withdraw the application based on the latest review suggestions from the National Medical Products Administration, indicating a need for further clinical case studies before resubmission [1] Group 2: Financial Impact - The withdrawal of the drug registration application will lead to a full impairment provision for the related development expenses, resulting in a reduction of approximately 111 million yuan in the total profit for the year 2025 [1] - For the first three quarters of 2025, Kaiyin Technology reported a revenue of 927 million yuan and a total profit of 131 million yuan, highlighting the significant impact this withdrawal will have on the company's overall performance for the year [1]

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]