Youcare Pharmaceutical (SH:688658) Ge Long Hui A P P·2025-09-22 09:27Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval for clinical trials to treat chronic hepatitis B virus infection [1] Group 1: Product Development - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine (GalNAc) ligand [1] - The drug works through RNA interference to effectively silence the HBV genome's messenger RNA, inhibiting the production of hepatitis B pathogen proteins and HBV replication [1] - The ultimate goal of YKYY013 is to achieve functional cure for hepatitis B by creating conditions for host immune reconstitution [1] Group 2: Regulatory Approval - The FDA has issued a Study May Proceed Letter (IND number: 177486) allowing the company to initiate clinical trials for YKYY013 [1] - This regulatory milestone is significant for the company's pipeline and potential market entry in the hepatitis B treatment sector [1]