康泰医学公告称收FDA警告信

Core Viewpoint - 康泰医学 has received a warning letter from the FDA, which may impact its operations in the U.S. market, a significant revenue source for the company [2][3]. Group 1: Company Performance - As of October 13, 康泰医学's stock closed at 15.99 CNY per share, down 2.50%, with a trading volume of 55,300 shares and a total market capitalization of 6.425 billion CNY [1]. - In the first half of 2025, 康泰医学 achieved a revenue of 218 million CNY, representing a year-on-year growth of 2.72%, and a net profit of 16.94 million CNY, which is a significant increase of 107.39% year-on-year [3]. Group 2: Regulatory Issues - The warning letter from the FDA was issued based on an inspection conducted from June 9 to June 12, 2025, highlighting non-compliance with the medical device quality system regulations [2]. - 康泰医学 plans to respond to the FDA within the specified timeframe, detailing corrective actions and timelines to address the issues raised [2]. Group 3: Market Impact - The U.S. market is crucial for 康泰医学, contributing 11.44 million CNY in sales revenue in 2024, accounting for 23.84% of total revenue, and 4.19 million CNY in the first half of 2025, making up 19.26% of total revenue [3].