Leads Biolabs-B (09887.HK): LBL-024 Granted Fast Track Designation by the U.S. FDA for First-Line Treatment of Advanced Biliary Tract Cancer

Zhito Finance APP News, Leads Biolabs-B (09887.HK) announced that the Company's core product Lixin (opartusumib, a PD-L1/4-1BB bispecific antibody) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the first-line treatment of advanced biliary tract cancer (BTC). This is the second FDA Fast Track designation granted to Lixin following its designation for extrapulmonary neuroendocrine carcinoma (EP-NEC). Based on the promising data demonstrated by Lixin in first-line BTC clinical studies, this Fast Track designation took only 9 days from submission to approval. The FDA also recommended that the Company promptly engage in communication regarding the registration plan for Lixin in combination with chemotherapy for BTC. This designation is expected to accelerate the development, registration, and commercialization process of Lixin for the treatment of BTC in the United States.