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悦康药业:子公司YKYY013注射液获国家药监局临床试验批准

Core Viewpoint - Yuyuan Pharmaceutical's subsidiary Yuyuan Kechuang and Hangzhou Tianlong have received approval from the National Medical Products Administration for the clinical trial of YKYY013 injection for the treatment of chronic hepatitis B virus infection, marking a significant step in the drug's development [1] Group 1 - The YKYY013 injection is a self-developed chemical-synthesized double-stranded siRNA drug [1] - Preclinical studies have shown significant HBV virus suppression activity and good safety profile for YKYY013 [1] - The drug has also received clinical trial approval from the U.S. FDA recently [1] Group 2 - The initiation of Phase I clinical trials is set to begin following the approval [1] - The company acknowledges that drug development involves long cycles, multiple stages, and high risks, which contribute to uncertainties [1] - There is no significant impact on the company's recent performance due to the drug's development status [1]