Baili Tianheng (02615.HK) said its in-house bispecific ADC iza-bren (BL-B01D1)
has had a marketing application for triple-negative breast cancer accepted by
the National Medical Products Administration’s Center for Drug Evaluation. The
filing covers treatment of unresectable locally advanced or metastatic TNBC in
patients who progressed on prior taxane therapy. This is the drug’s third MAA
acceptance by the CDE, after submissions for nasopharyngeal carcinoma and
esophageal squamous cell carcinoma.