HanYu Pharmaceutical: Tirzepatide Injection Receives U.S. FDA Acceptance for 2 ANDAs as First Generic Approvals for Diabetes Blood Sugar Control and Weight Loss

Hybio Pharmaceutical announced that its Abbreviated New Drug Application (ANDA) for tirzepatide injection, submitted to the U.S. Food and Drug Administration (FDA), has received a filing review notice. Tirzepatide is a dual GLP-1R/GIPR agonist developed by Eli Lilly, occupying an important position in the global weight loss and blood glucose-lowering drug market, with no generic products yet available worldwide. Tirzepatide's global sales in 2025 totaled approximately $36.51B, ranking first in global sales for 2025.
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