Chinese Drug Regulator Denies Marketing of Shyndec Pharmaceutical's UTI Treatment Drug

MT Newswires Live

Jan 03, 2025

The Chinese drug administration denied the application of Shanghai Shyndec Pharmaceutical's (SHA:600420) unit, Sinopharm Zhijun (Shenzhen) Pharmaceutical, to market fosfomycin tromethamine granules, according to a Shanghai Stock Exchange disclosure on Friday.

The application did not meet relevant requirements for drug registration, the pharmaceutical company said.

The drug was developed to treat infections caused by sensitive Escherichia coli, Enterococcus faecalis, Klebsiella pneumoniae, Citrobacter, Enterobacter, and Proteus mirabilis, such as acute simple urinary tract infection.

The company, which spent 11.5 million yuan into the drug's research and development, said it will re-initiate the research, application and registration work for the drug.

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