CDE Accepts Baili-Bio's Yizekang Filing for HR-Positive, HER2-Negative Breast Cancer
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China's Center for Drug Evaluation has accepted Baili-Bio's marketing application for Yizekang, the company's first commercialized innovative drug, as a fourth indication filing. Yizekang is the lunkangyilongtu antibody (BL-B01D1/iza-bren), a bispecific antibody-drug conjugate, intended for patients with unresectable or metastatic HR-positive, HER2-negative breast cancer previously treated with endocrine therapy and at least one line of chemotherapy for advanced disease. The application rests on interim analysis of a Phase III trial, described as the first bispecific ADC Phase III study to hit its primary endpoint in this setting. What remains open is the regulatory review outcome and, with it, whether the indication reaches the market.
Written by a model from the reports · updated 2 hours ago
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- mp.weixin.qq.comPickBaili-Bio's Yizekang HR-Positive HER2-Negative Breast Cancer Application Accepted by CDE
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.
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