Tibet Pharmaceutical: Controlling subsidiary's ART002g1 injection receives U.S. FDA clinical trial approval

Tibet Pharmaceuticals announced that ACCUREDIT THERAPEUTICS US LIMITED, a subsidiary of its controlling subsidiary, received notice from the U.S. FDA approving the proposed clinical study of ART002g1 injection in the United States. The drug is an in vivo gene editing therapy targeting PCSK9, indicated for adult heterozygous familial hypercholesterolemia and adult hypercholesterolemia in patients at high/very high risk of atherosclerotic cardiovascular disease. As of the announcement date, cumulative R&D investment in the drug reached RMB 66.0316 million. The product is currently in the early research stage, and there is uncertainty regarding whether it will ultimately be approved for marketing and when such approval may be granted.