The new drug application for Envituzumab Injection, developed by CSPC PHARMA (01093), has been accepted for review by China's National Medical Products Administration.

The application is submitted as a Category 1 new biological therapeutic product. Its indicated use is for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies.

Envituzumab Injection is a HER2-targeted antibody-drug conjugate. The drug works by binding to HER2 receptors on tumor cells, which triggers its internalization. Once inside the cell, it is broken down in lysosomes, releasing the cytotoxic agent MMAE. This agent inhibits tubulin polymerization during the cell division cycle, ultimately leading to tumor cell death.

Trial Data and Results

The submission is primarily supported by data from a pivotal Phase III clinical trial. The trial enrolled patients with HER2-positive unresectable or metastatic breast cancer who had received at least prior trastuzumab and taxane-based therapy.

The results demonstrated that, compared to T-DM1, Envituzumab Injection significantly extended progression-free survival when used as a second-line or later treatment for advanced HER2-positive breast cancer. This improvement was both statistically significant and clinically meaningful.

Analyses of other secondary endpoints and patient subgroups consistently indicated that Envituzumab Injection possesses superior anti-tumor efficacy over T-DM1. The product also demonstrated a favorable safety and tolerability profile.

Clinical Value

Given its advantages in both efficacy and safety, Envituzumab Injection holds strong potential for clinical application, with the aim of providing a beneficial new treatment option for a greater number of patients.