Lilly Submits First Clinical Application in China for Oral SERD Imlunestrant, Exploring Combination with Abemaciclib in ER+/HER2- Breast Cancer

On March 25, the CDE website showed that Eli Lilly and Company's oral Selective Estrogen Receptor Degrader (SERD) Imlunestrant was submitted for clinical trial in China for the first time.

Source: CDE Official Website

Imlunestrant, with the R&D code LY-3484356, was first initiated in clinical trials outside of China in November 2019, according to the Insight database.

On July 22, 2021, Eli Lilly registered a Phase III clinical trial, EMBER-3 study, on ClinicalTrials.gov for Imlunestrant in combination with Abemaciclib for the treatment of ER+/HER- advanced breast cancer. This trial includes 33 centers in mainland China, although patient recruitment has not yet started in China. Today, Eli Lilly submitted the clinical trial application for this drug in China for the first time.

Imlunestrant Global Development Progress

Source: Insight Database Global New Drug Module (http://db.dxy.cn/v5/home/)

Eli Lilly has the CDK4/6 inhibitor abemaciclib for the treatment of breast cancer. Abemaciclib is one of the "three giants" of global CDK4/6 inhibitors. Although it is not the variety with the highest market share in the same target, its growth has been accelerating in recent years. In 2021, the global revenue reached 1.35 billion US dollars, a year-on-year increase of 48%.

Clinically, abemaciclib can still be effective for patients who have developed resistance to palbociclib, and it has taken the lead in adjuvant therapy for early breast cancer, becoming the only CDK4/6 inhibitor currently approved for this indication.

Note: The original text has been abridged.