Changchun High-Tech Industry Group's (SHE:000661) unit, Changchun Jinsai Pharmaceutical, received implied approval from the US Food and Drug Administration for the clinical trial of the menopausal vasomotor syndrome drug, GS1-144, according to a Shenzhen Stock Exchange disclosure on Tuesday.
The biopharmaceutical company is allowed to begin clinical trials for the drug after the application for the phase II clinical trials reached the regulator's implicit approval period, the filing said.
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