智通财经网·2025-12-14 11:01Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (JS212) for the treatment of advanced solid tumors [1] Group 1: Product Overview - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily aimed at treating advanced malignant solid tumors [1] - EGFR and HER3 are highly expressed on the surface of various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - JS212 is expected to have a broader efficacy against tumors and to overcome resistance issues compared to single-target ADC drugs, as it can exert tumor-suppressing effects through binding to either EGFR or HER3 [1] Group 2: Clinical Trials and Approvals - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) and received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A multi-cohort combination therapy clinical trial application for JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]