Lilly's Class 1 New Drug Imlunestrant Tablet Receives NMPA Acceptance for Marketing Application in China for Breast Cancer Treatment

According to the SmartCom APP,Today (April 8), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that the marketing application for Imlunestrant Tablets, a Class 1 new drug submitted by Eli Lilly and Company (LLY.US), has been accepted.Public information shows that this is an oral selective estrogen receptor degrader (SERD) under development by Eli Lilly and Company. The phase 3 clinical study of this product for the treatment of patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer has previously achieved positive results.

Screenshot source: CDE official website

In recent years, protein degradation therapies targeting ER have begun to emerge as an important treatment modality for breast cancer. Selective estrogen receptor degraders (SERDs) bind to ER and induce structural changes in ER, enabling the E3 ubiquitin ligase in cells to better recognize ER and tag it as "trash," ultimately leading to the degradation of ER in the cell's proteasome.

Imlunestrant is a small-molecule SERD drug capable of crossing the blood-brain barrier. Its design goal is to continuously inhibit the activity of the ER target throughout the dosing period, regardless of the ESR1 mutation status. ESR1 mutations are the main variant form of endocrine therapy resistance in breast cancer patients, with an incidence rate as high as 20% to 50% in patients with advanced breast cancer, especially those who have previously received aromatase inhibitor treatment.