Yuekang Pharmaceutical (688658.SH): The subsidiary YKYY032 injection was approved for clinical trials by the National Drug Administration and FDA

Zhitong Finance App News, Yuekang Pharmaceutical (688658.SH) issued an announcement. The company's subsidiaries, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. were recently approved and issued by the National Drug Administration (“NMPA”) for the “Drug Clinical Trial Approval Notice” for YKYY032 injection for the treatment of hyperlipoprotein (a) emia. Yuekang Kechuang recently obtained a letter from the US Food and Drug Administration (“FDA” for short) regarding approval of YKYY032 injection for clinical trials in the treatment of hyperlipoprotein (a) anemia (StudyMayProceedLetter, IND number: 178774).

YKYY032 injection is a chemically synthesized double-stranded siRNA drug conjugated to N-acetylgalactosamine (GalNAc) ligands. It specifically silences mRNA transcribed by the LPA gene through an RNA interference mechanism, blocks lipoprotein (a) [Lp (a)] production at the source, and is intended for the treatment of hyperlipoprotein (a). Preclinical studies have shown significant pharmacological activity in vitro and in vivo. It can effectively reduce LpAMRNA and LP (a) protein levels in various animal models. It is also accompanied by a decrease in LDL-c and ApoB levels in non-human primates, showing good and long-lasting lipid-lowering effects, and repeated administration toxicity studies have confirmed that it has good safety and tolerability.