Tilpotide is the world’s first and currently the only GIP/GLP-1 receptor agonist.

This approval is mainly based on the global key phase III registration trial named SURPASS 1-5 and the Asia Pacific key phase III registration trial named SURPASS AP Combo (83.4% of participants are Chinese patients).

SURPADS-AP-Combo is a 40 week multi country, multicenter, randomized, open label (with both researchers and subjects informed of actual administration) phase III clinical trial that compares the efficacy and safety of three different doses (5 mg, 10 mg, and 15 mg) of tilboptin and dose titrated insulin glargine treatment in patients with approved indications.

The trial included 917 participants from China, South Korea, India, and Australia, who were randomly assigned in a 1:1:1:1 ratio to receive different doses of tilpotide or titrated doses of insulin glargine treatment. The primary endpoint is to evaluate the non inferiority of the reduction of glycated hemoglobin by 10mg and/or 15mg of tiltrotide from baseline to 40 weeks to insulin glargine, while the key secondary endpoints include the non inferiority of the reduction of glycated hemoglobin by 5mg of tiltrotide from baseline to 40 weeks to insulin glargine.