药品注册申请撤回
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凯因科技2025年度归母净利润2963.12万元 同比下降79.19%
Zhi Tong Cai Jing· 2026-02-27 16:22
Core Viewpoint - The company reported a total operating revenue of 1.321 billion yuan for the fiscal year 2025, reflecting a year-on-year growth of 7.35%. However, the net profit attributable to the parent company was 29.6312 million yuan, showing a significant decline of 79.19% compared to the previous year due to substantial asset impairment provisions [1]. Financial Performance - Total operating revenue reached 1.321 billion yuan, marking a 7.35% increase year-on-year [1]. - Net profit attributable to the parent company was 29.6312 million yuan, which represents a 79.19% decrease year-on-year [1]. Reasons for Performance Changes - The primary reason for the performance decline was the company's decision to make a large asset impairment provision. This was influenced by the latest review recommendations from the National Medical Products Administration [1]. - The company voluntarily withdrew the drug registration application for the interferon α-2 injection (new hepatitis B indication), leading to a full impairment provision for the remaining development expenses of this project [1].
凯因科技(688687.SH)业绩快报:2025年归母净利润2963.12万元 同比下降79.19%
Ge Long Hui A P P· 2026-02-27 15:51
Core Viewpoint - Kaiyin Technology (688687.SH) reported a significant decline in net profit for the year 2025, primarily due to substantial asset impairment provisions related to the withdrawal of a drug registration application [1] Financial Performance - The company achieved total operating revenue of 1.321 billion yuan, representing a year-on-year increase of 7.35% [1] - The net profit attributable to the parent company was 29.6312 million yuan, reflecting a year-on-year decrease of 79.19% [1] - The net profit attributable to the parent company after deducting non-recurring gains and losses was 22.7647 million yuan, down 83.38% year-on-year [1] Reasons for Performance Changes - The primary reason for the performance decline was the company's decision to fully provision for asset impairment related to the withdrawal of the drug registration application for Pegylated Interferon α-2 Injection (new hepatitis B indication) based on the latest review recommendations from the National Medical Products Administration [1]
凯因科技撤回乙肝适应症药品申请,2025年利润减少1.11亿元
Zhong Guo Jing Ying Bao· 2026-01-21 02:41
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。 ...