Core Viewpoint - The news highlights that EnGene Biotech-B (09606) has seen a stock price increase following the announcement that its partner Avenzo Therapeutics has received Fast Track designation from the FDA for its dual-specific antibody drug conjugate AVZO-1418/DB-1418, aimed at treating non-small cell lung cancer (NSCLC) patients with specific mutations [1][2]. Group 1: Company Developments - EnGene Biotech-B's stock rose nearly 3% in early trading, currently at 301 HKD with a trading volume of 18.1 million HKD [1]. - Avenzo Therapeutics, a clinical-stage biotechnology company, announced the FDA's Fast Track designation for AVZO-1418/DB-1418, which is a significant milestone for the drug's development [1][2]. Group 2: Product and Clinical Trials - The Fast Track designation is specifically for the treatment of patients with unresectable locally advanced or metastatic NSCLC who have specific EGFR mutations and have progressed after TKI treatment [2]. - AVZO-1418/DB-1418 is currently undergoing an open-label Phase 1/2 clinical trial to evaluate its safety, tolerability, and preliminary clinical activity as a monotherapy and in combination therapy for patients with advanced solid tumors [2].
港股异动 | 映恩生物-B(09606)早盘涨近3% DB-1418获FDA授予快速通道资格