Core Viewpoint - Invenra Biologics-B (09606) experienced a significant stock increase of over 8%, currently trading at 329.6 HKD with a transaction volume of 658 million HKD, following the announcement of FDA's Fast Track designation for DB-1418 targeting inoperable locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: FDA and Regulatory Approvals - On November 11, Invenra Biologics announced that DB-1418 received Fast Track designation from the FDA for treating inoperable locally advanced or metastatic NSCLC patients [1] - On November 12, the China National Medical Products Administration (NMPA) publicly announced the clinical approval of Invenra's new drug DB-1418 for the treatment of advanced/metastatic malignant solid tumors [1] Group 2: Collaboration and Financial Aspects - Earlier in January, Invenra Biologics entered into a global development collaboration with Avenzo Therapeutics for the bispecific ADC product AVZO-1418/DB-1418, which targets EGFR/HER3 [1] - According to the agreement, Invenra will receive an upfront payment of 50 million USD and is eligible for up to 1.15 billion USD in milestone payments related to development, registration, and commercialization [1] - Additionally, Invenra is entitled to a share of sales revenue from Avenzo within its region [1]
映恩生物-B再涨超8% DB-1418获FDA授予快速通道资格 同时在中国获批临床