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

This approval is primarily based on the global pivotal Phase III registration trial SURPASS 1–5 and the Asia-Pacific pivotal Phase III registration trial SURPASS-AP-Combo (83.4% of participants were Chinese patients).

SURPASS-AP-Combo is a 40-week, multinational, multicenter, randomized, open-label (investigator and participant information was available) Phase III clinical trial comparing the efficacy and safety of thiopeptide at three different doses (5 mg, 10 mg, and 15 mg) versus dose-titered insulin glargine in patients with the aforementioned approved indication.

This trial enrolled 917 participants from China, South Korea, India, and Australia, who were randomized in a 1:1:1:1 ratio to receive either a different dose of thiopeptide or a dose-titered insulin glargine. The primary endpoint was to assess the non-inferiority of telpoide 10 mg and/or 15 mg in reducing HbA1c from baseline to 40 weeks compared to insulin glargine. Key secondary endpoints included the non-inferiority of telpoide 5 mg in reducing HbA1c from baseline to 40 weeks compared to insulin glargine.