悦康药业(688658.SH)：子公司YKYY032注射液获国家药品监督管理局和FDA临床试验批准

Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) has received approval from the National Medical Products Administration (NMPA) for its subsidiary's clinical trial of YKYY032 injection for the treatment of lipoprotein(a) hyperlipidemia, as well as a "Study May Proceed" letter from the FDA for the same purpose [1][1]. Group 1 - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have obtained the NMPA's approval for the clinical trial of YKYY032 injection [1]. - The FDA has granted a "Study May Proceed" letter for YKYY032 injection, indicating that clinical trials can commence in the United States [1]. - YKYY032 injection is a chemically synthesized double-stranded siRNA drug that targets the LPA gene to block the production of lipoprotein(a) [Lp(a)] through RNA interference mechanisms [1]. Group 2 - Preclinical studies have demonstrated significant pharmacological activity of YKYY032, effectively reducing LPAmRNA and Lp(a) protein levels in various animal models [1]. - In non-human primate models, YKYY032 has shown a reduction in LDL-C and ApoB levels, indicating a good and lasting lipid-lowering effect [1]. - Toxicity studies from repeated dosing have confirmed the drug's good safety and tolerability profile [1].