主动撤回药物上市申请,这家公司成今日上午A股跌幅最大企业

Core Viewpoint - The company Kain Technology (688687.SH) has voluntarily withdrawn its drug registration application for a hepatitis B treatment, leading to a significant drop in its stock price by 11.78% on January 21, making it the largest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].

主动撤回药物上市申请,这家公司成今日上午A股跌幅最大企业 - Reportify