The new drug marketing application for the envirastuzumab injection developed by CSPC Group (01093) has been accepted by the State Drug Administration

According to Zhitong Finance App News, Shiyao Group (01093) announced that the new drug marketing application for the envitrazumab injection developed by the group has been accepted by the China Drug Administration. This product is declared as a biological product class 1 new drug for therapeutic use. Its indication is unresectable or metastatic HER2 positive adult breast cancer that has been treated with one or more anti-HER2 drugs in the past.

Envirastuzumab injection is an antibody-conjugated drug (ADC) targeting HER2. The product can bind to HER2 receptors on HER2 positive tumor cells and induce internalization, then hydrolyze in lysosomes to release MMAE, thereby inhibiting tubulin polymerization during the tumor cell division cycle, and ultimately induces tumor cell death and exerts an anti-tumor effect.

The marketing application for this product is mainly based on a key phase III clinical trial. The enrolled patients are HER2-positive unresectable or metastatic breast cancer patients who have received at least previous treatment with trastuzumab and paclitaxel. The results showed that compared with T-DM1, this product can significantly prolong progression-free survival (PFS) for second-line treatment of HER2-positive advanced breast cancer and has significant statistical and clinical significance. Other secondary endpoints and subgroup analysis results showed that the product had better anti-tumor efficacy than T-DM1. At the same time, the product is safe and well tolerated.

Based on its advantages in efficacy and safety, the product has good clinical application value to benefit more patients.