HRS-7535: Obesity, diabetes drug meets main goal in late-stage trials

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Kailera Therapeutics said on Tuesday that HRS-735, its oral obesity and ​diabetes drug, met the main goal of two late-stage ‌trials conducted by its partner Jiangsu Hengrui Pharmaceutical in China.

US drugmakers have been increasingly looking to China to secure the rights to promising drug candidates ​at a lower cost and access important early data that ​could pave the way for global trials.

In the obesity ⁠trial, the drug, HRS-7535, achieved a mean weight loss of ​up to 10.9% at week 44 and a mean weight loss ​of up to 11.1% at week 50.

The drug was also found to be non-inferior to AstraZeneca’s dapagliflozin across dose levels in the diabetes trial in terms of ​reducing HbA1c levels, a key marker of long-term blood sugar ​levels.

Over 2,000 participants have received the drug in clinical trials in China. Kailera said no ‌liver ⁠safety signals were observed in both trials.

Eli Lilly and Novo Nordisk currently dominate the obesity drug race, but the field is quickly crowding as new and established players rush to capture a market ​poised to hit $150 ​billion over the ⁠next decade.

Kailera Therapeutics was launched in October 2024 with $400 million in early-stage funding and four obesity ​drug candidates licensed from Hengrui.

In February, Kailera said the ​oral ⁠version of its lead drug, ribupatide, helped patients lose up to 12.1% body weight at 26 weeks in a mid-stage study in China.

Kailera is ⁠also ​advancing HRS-7535 in a global mid-stage clinical trial ​in overweight or obese adults. The trial started in April, with data expected next year.

About HRS-7535 (KAI-7535)

HRS-7535 (being developed by Kailera as KAI-7535) is a small molecule GLP-1 receptor agonist, which was designed to improve upon the clinical profile of existing oral treatments. It was developed by Hengrui Pharma and licensed to Kailera outside of Greater China in 2024. Over 2,000 patients to date have been dosed with HRS-7535 in clinical trials in China. Kailera is conducting a global Phase 2 trial of KAI-7535 for the treatment of obesity, with data expected in 2027.