Tibet Rhodiola Pharmaceutical's Subsidiary Secures FDA Clinical Trial Approval for ART002g1 Injection

Stock News10-16

Tibet Rhodiola Pharmaceutical Holding Co. (600211.SH) has announced that its controlling subsidiary's affiliate, ACCUREDIT THERAPEUTICS US LIMITED, recently received notification from the U.S. Food and Drug Administration (FDA) approving clinical trials for ART002g1 injection.

The indications for ART002g1 injection include adult heterozygous familial hypercholesterolemia (HeFH) and adult hypercholesterolemia in patients with high or very high-risk atherosclerotic cardiovascular disease (ASCVD).

ART002g1 injection is an in vivo gene editing therapeutic targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). ART002g1 further optimizes components such as mRNA and gRNA based on ART002.

Regarding the PCSK9 target, products with mechanisms such as monoclonal antibodies and siRNA (small interfering RNA) have already been approved for marketing, while no products in the in vivo gene editing field have yet received marketing approval.

As of the date of this announcement, the cumulative research and development investment for this drug amounts to RMB 66.0316 million (unaudited).

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