Lilly's Tirzepatide Granted IND Approval in China for New Indication in Moderate-to-Severe Obstructive Sleep Apnea

On April 28, Eli Lilly's GLP-1R/GIPR dual agonist Tirzepatide received clinical approval for a new indication in China, for use as a single-intervention drug therapy in adult patients with moderate to severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥30kg/m².

Source: CDE Official Website

Hypoglycemic drugs led by GLP-1 analogs have gradually surpassed insulin, becoming the dominant players in the hypoglycemic drug market. Dual or triple agonists targeting GLP-1R, GIPR, GCGR, and other receptors have already demonstrated outstanding efficacy surpassing previous-generation drugs in clinical settings, prompting pharmaceutical companies to compete in strategic development.

For dual-target antidiabetic drugs, Eli Lilly's Tirzepatide is the one with the most advanced development progress. Last October, it had already used a priority review voucher to submit a New Drug Application (BLA) to the FDA. In terms of indication development, Eli Lilly is not limited to diabetes but is expanding the indications of Tirzepatide to various metabolic diseases, from type 2 diabetes to obesity, kidney disease (CKD), and obstructive sleep apnea (OSA). The diabetes field is led by a series of SURPASS studies, while obesity and related metabolic diseases are led by a series of clinical SURMOUNT studies.

Tirzepatide Clinical Research Program

In China, Eli Lilly submitted the IND application for the Tirzepatide project for the first time in April 2019, initiated clinical trials in August of the same year, and is currently advancing five Phase III clinical trials targeting type 2 diabetes, heart failure, and obesity.

Tirzepatide Phase III Clinical Indications in China

Data source: Insight Database (http://db.dxy.cn/v5/home/)

Eli Lilly indicated in its R&D Day last December that diabetes and obesity are underlying factors for various metabolic diseases. Eli Lilly has already established a rich pipeline targeting diabetes, and in the upcoming development, it is linking multiple diseases associated with obesity, aiming at cardiovascular diseases, sleep apnea syndrome, kidney diseases, and more fields. This also represents a forward shift in treatment.

Eli Lilly's Diabetes and Obesity Drug Development Strategy

According to the Insight database, Eli Lilly's drug development in the metabolic field is concentrated on the GLP1R and insulin targets, with indications mainly focused on diabetes. However, the GCGR target and obesity indications rank third in frequency of appearance, already reflecting a trend towards the concentrated layout of next-generation drugs.

Overview of New Drug Targets and Indications in Eli Lilly's Metabolic Field

Screenshot source: Insight Database Global New Drugs (http://db.dxy.cn/v5/home/)

Eli Lilly is simultaneously developing new drugs with various mechanisms to consolidate and enhance the company's position in the metabolic field. Currently, this field is dominated by GLP-1 class drugs, and in the next 2-4 years, dual-target agonists will be the focus of development; after 4 years, next-generation drugs such as triple-target agonists and small molecule drugs will emerge.

Future Drug Development Plans in the Field of Obesity