Eli Lilly Soars 2.86% on China NDA Acceptance for Imlunestrant

On April 8, 2025, Eli Lilly's stock rose by 2.86% in pre-market trading, reflecting positive market sentiment towards the company's recent developments.

Eli Lilly has made significant strides in its drug development pipeline, particularly with its oral selective estrogen receptor degrader (SERD) imlunestrant. The company recently announced that its New Drug Application (NDA) for imlunestrant has been accepted by the China National Medical Products Administration (NMPA). This drug is designed to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, a population that has shown promising results in clinical trials.

Imlunestrant has demonstrated its efficacy in the EMBER-3 trial, a phase 3 study involving 874 patients. The results showed that imlunestrant significantly improved progression-free survival (PFS) compared to standard endocrine therapy (SOC ET) in patients with ESR1 mutations, reducing the risk of disease progression or death by 38%. Additionally, when combined with the CDK4/6 inhibitor abemaciclib, imlunestrant further enhanced PFS across all patient subgroups, regardless of ESR1 or PI3K pathway mutations, and previous CDK4/6 inhibitor treatment.

The acceptance of the NDA for imlunestrant in China marks a significant milestone for Eli Lilly, as it expands the potential market for this innovative treatment. The drug's ability to cross the blood-brain barrier and its sustained inhibition of ER activity, even in the presence of ESR1 mutations, positions it as a promising option for patients who have developed resistance to existing endocrine therapies.