Core Viewpoint - The stock of InnoCare Pharma (09606) rose nearly 3% in early trading, currently up 2.23% at 301 HKD, with a trading volume of 18.1 million HKD, following the announcement that its partner Avenzo Therapeutics received FDA fast track designation for its EGFR/HER3 bispecific antibody drug conjugate AVZO-1418/DB-1418 [1][2]. Group 1 - Avenzo Therapeutics, a clinical-stage biotechnology company focused on next-generation cancer therapies, has been granted fast track designation by the FDA for AVZO-1418/DB-1418, aimed at treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) [1][2]. - The fast track designation is specifically for patients with EGFR mutations (exon 19 deletions or L858R mutations) who have experienced disease progression after treatment with EGFR tyrosine kinase inhibitors (TKIs) [2]. - Currently, AVZO-1418/DB-1418 is 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].
映恩生物-B早盘涨近3% DB-1418获FDA授予快速通道资格