mp.weixin.qq.com·· 5 hours agoPickScore64
Baili-Bio's Yizekang HR-Positive HER2-Negative Breast Cancer Application Accepted by CDE
In brief
On October 22, the CDE accepted Baili-Bio's marketing application for Yizekang, its first commercialized innovative drug, in HR-positive, HER2-negative breast cancer, its fourth indication filing. Yizekang is lunkangyilongtu antibody (BL-B01D1/iza-bren), intended for unresectable or metastatic patients previously treated with endocrine therapy and at least one line of chemotherapy for advanced disease. The application is based on interim analysis of a Phase III trial, described in the source as the first bispecific ADC Phase III study to hit its primary endpoint in this setting.
Why it matters
Filing rests on Phase III interim analysis with clearly defined prior endocrine therapy and chemotherapy lines.
Source: mp.weixin.qq.com · mp.weixin.qq.com