The application for the listing of the Class 1 new drug Imlunestrant tablets by LLY. US in China for the treatment of breast cancer has been accepted.

Today (April 8th), the latest announcement on the official website of the China National Medical Product Administration Drug Evaluation Center (CDE) reveals that Eli Lilly and Company has had its application for the market approval of a type 1 new drug imlunestrant tablets accepted. Public information shows that this is an oral selective estrogen receptor degrader (SERD) being developed by Eli Lilly. The product has shown positive results in phase 3 clinical studies for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer patients. In recent years, protein degradation therapy targeting ER has become an important treatment modality for breast cancer. Selective estrogen receptor degraders (SERD) bind to ER, inducing structural changes that allow E3 ubiquitin ligase to better identify ER and tag it with a "garbage" label, ultimately leading to ER degradation in the cell's proteasome. Imlunestrant is a small molecule SERD drug that can cross the blood-brain barrier. Its design goal is to continuously inhibit ER activity throughout the entire dosing period, regardless of the ESR1 mutation status. ESR1 mutation is a major form of endocrine therapy resistance in breast cancer patients, with a high incidence of 20%-50% in advanced breast cancer patients, especially those who have received aromatase inhibitor therapy.