凯因科技: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

Core Viewpoint - The company, Kaiyin Technology, has voluntarily withdrawn its drug registration application for Pegylated Interferon α-2 Injection (new hepatitis B indication) as approved by the National Medical Products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]

Kawin Technology-凯因科技: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 - Reportify