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Core Viewpoint - The company, Kaiyin Technology, has voluntarily withdrawn its drug registration application for Pegylated Interferon α-2 Injection for the treatment of chronic hepatitis B, leading to a significant drop in its stock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Financial Implications - The company has fully recognized impairment losses related to the development expenses of the withdrawn application, reducing its profit by 111 million yuan for the fiscal year 2025 [6].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].