Shen Zhen Shang Bao·2025-10-14 07:05Core Insights - Fudan Zhangjiang's subsidiary failed to obtain approval from the National Medical Products Administration (NMPA) for the drug Obecholic Acid Tablets, which is intended for the treatment of primary biliary cholangitis (PBC) [1] - The drug is classified as a Class 3 generic chemical drug and is a Farnesoid X receptor agonist that regulates bile acid metabolism [1] - The NMPA's rejection was primarily due to the lack of sufficient evidence supporting the drug's benefits outweighing risks, as the reference drug has not received regular approval abroad [1] Company Performance - Fudan Zhangjiang reported a revenue of 390 million yuan in the first half of the year, a year-on-year decline of 4.42% [2] - The company's net profit attributable to shareholders was 5.71 million yuan, a significant drop of 91.89% year-on-year [2] - Since 2022, the company's net profit has been on a downward trend, with declines of 35.3% in 2022, 21.3% in 2023, and a projected 63.4% drop in 2024 [2] Investment Context - Despite a 20% increase in stock price this year, Fudan Zhangjiang's current stock price is only about 20% of its historical high point since its listing in July 2020 [2] - The company has invested a total of 125 million yuan (unaudited) in the development of Obecholic Acid, which has been fully accounted for in the respective accounting periods [1]