Core Viewpoint - The company Junshi Biosciences (01877.HK) has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA notification indicates a significant milestone for the company in advancing its oncology pipeline [1] - The approval allows the company to proceed with clinical trials, which could lead to potential market opportunities if successful [1]

Core 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]

Core Viewpoint - Junshi Biosciences (01877.HK) has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA notification indicates a significant milestone for Junshi Biosciences in advancing its oncology pipeline [1] - The approval allows the company to initiate clinical trials, which could lead to potential market opportunities in the oncology sector [1] - JS212 represents a novel therapeutic approach targeting specific cancer pathways, highlighting the company's commitment to innovation in cancer treatment [1]

Core Viewpoint - Junshi Biosciences (stock code: 688180) announced that its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA) [1] Group 1 - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The primary indication for JS212 is the treatment of advanced malignant solid tumors [1]

Core Viewpoint - Junshi Biosciences (688180) announced on December 14 that it has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA approval allows Junshi Biosciences to proceed with clinical trials for JS212, which is designed to treat advanced malignant solid tumors [1] - JS212 is a recombinant humanized bispecific antibody targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The drug aims to address the treatment needs for patients with advanced solid tumors, indicating a potential advancement in cancer therapy [1]