复旦张江一新药上市被拒

Core Viewpoint - Fudan Zhangjiang's subsidiary failed to obtain approval from the National Medical Products Administration for its drug Obecholic Acid Tablets, which is intended for the treatment of Primary Biliary Cholangitis (PBC) [1] Company Summary - The drug Obecholic Acid Tablets is classified as a Class 3 chemical generic drug and acts as a Farnesoid X receptor agonist to regulate bile acid metabolism for PBC treatment [1] - Fudan Zhangjiang completed the human bioequivalence study for the drug in July 2020 and submitted the application for market approval in October last year, which was accepted [1] - The company invested a total of 125 million yuan (approximately 17.5 million USD) in the drug development, which has been fully accounted for in the respective financial periods [1] Financial Performance - In the first half of the year, the company reported revenue of 390 million yuan (approximately 54.5 million USD), a year-on-year decrease of 4.42% [1] - The net profit attributable to the parent company was 5.71 million yuan (approximately 800,000 USD), representing a significant year-on-year decline of 91.89% [1]