CSPC PHARMA's new drug application for Envelquatuzumab injection has been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that the new drug application for the Enfortumab Vedotin Injection developed by the group has been accepted by the National Medical Products Administration of the People's Republic of China. The product is classified as a Class 1 new drug for therapeutic biologics, indicated for unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs. Enfortumab Vedotin Injection is a HER2-targeted antibody-drug conjugate (ADC) that binds to the HER2 receptor on HER2-positive tumor cells, induces internalization, and then hydrolyzes in lysosomes to release MMAE, thereby inhibiting microtubule protein polymerization in the tumor cells' division cycle, ultimately inducing tumor cell death and exerting anti-tumor effects. The new drug application is mainly based on a pivotal Phase III clinical trial involving patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane therapy. Results show that compared to T-DM1, this product significantly prolongs progression-free survival (PFS) in the second-line and later treatment of HER2-positive advanced breast cancer, with both statistically and clinically significant results. Other secondary endpoints and subgroup analysis results also demonstrate that this product has better anti-tumor efficacy compared to T-DM1. Additionally, the product has shown good safety and tolerability. Based on its advantages in efficacy and safety, this product has good clinical value and is expected to bring benefits to more patients.