百利天恒BL-B01D1上市申请获受理 系适用于食管癌治疗ADC药物
Zhong Zheng Wang·2026-01-20 08:00

Group 1 - The National Medical Products Administration (NMPA) accepted the market application for the first-class new drug BL-B01D1, which is indicated for recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] - BL-B01D1 (Iza-bren) is a globally innovative dual-antibody ADC that blocks signals from EGFR and HER3 to tumor cells, inhibiting their proliferation and survival [1] - The drug's mechanism includes antibody-mediated endocytosis, which releases therapeutic payloads that induce genotoxic stress, ultimately leading to tumor cell death [1] Group 2 - In December 2023, the company entered into an exclusive licensing and collaboration agreement with Bristol-Myers Squibb (BMS) for the global development and commercialization of Iza-bren [2] - BMS will pay the company an upfront fee of $800 million, along with two milestone payments of $250 million each; additional payments could reach up to $7.1 billion based on development, registration, and sales milestones [2] - The total potential deal value could reach $8.4 billion, setting a record for the highest total price for a single drug licensing agreement in the ADC field [2] - Currently, there are only 10 biopharmaceutical new drugs approved for esophageal cancer treatment globally, with no ADCs approved yet; if approved, BL-B01D1 will be the first ADC for esophageal cancer treatment [2]

BIOKIN PHARMACEUTICAL-百利天恒BL-B01D1上市申请获受理 系适用于食管癌治疗ADC药物 - Reportify