Eli Lilly(LLY.US)'s new drug has been approved for key Phase 3 clinical trials in China

Recently, Eli Lilly (LLY.US) announced that its novel long-acting amylin receptor agonist, eloralintide, has been approved by the China National Medical Products Administration Drug Evaluation Center (CDE), and that it is simultaneously launching three global pivotal Phase 3 clinical studies in China, to support the product’s registration in China for multiple indications in the future, including weight management, in order to meet the clinical needs of patients with obesity or overweight and their related comorbidities, and to provide more effective and well-tolerated treatment options.

Eloralintide is a potent, selective, long-acting amylin receptor (AMYR) agonist that binds with high affinity to the human amylin type 1 receptor (AMY1R), while maintaining selectivity for the human calcitonin receptor (hCTR). While maintaining weight-loss efficacy, it also improves gastrointestinal reactions, thereby achieving a balance between efficacy and tolerability. The selectivity of eloralintide for the amylin receptor can reduce potential risks associated with calcitonin receptor activity. With a relatively long plasma half-life (about 14 days), the product is suitable for once-weekly subcutaneous (SC) administration.

Eloralintide is being developed for the following indications: as an adjunct therapy to diet control and exercise, for long-term weight management in adults with obesity or overweight alone (with at least 1 weight-related comorbidity); and for combination therapy, for long-term weight management in adult patients who have not achieved treatment targets after using stable-dose glucagon-like peptide (GLP-1) class drugs.