Zhi Tong Cai Jing·2025-12-15 01:52Core Viewpoint - Junshi Biosciences (01877) shares rose over 4%, currently up 4.33% at HKD 25, with a trading volume of HKD 34.83 million [1] Group 1: FDA Approval - On December 14, Junshi Biosciences announced that it received notification from the U.S. Food and Drug Administration (FDA) that its EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors has been approved for clinical trials [1] - The clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) in January 2025 and received approval in March 2025 [1] Group 2: Clinical Trials - As of the date of the announcement, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China, aimed at evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212 in patients with advanced solid tumors [1] - 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 [1]