Shang Hai Zheng Quan Bao·2025-12-14 20:29Group 1 - The company, Shanghai Junshi Biosciences Co., Ltd., has received FDA approval for the clinical trial application of JS212, a bispecific antibody-drug conjugate targeting EGFR and HER3 for the treatment of advanced solid tumors [1] - JS212 is designed to target tumors with high expression of EGFR and HER3, such as lung cancer, colorectal cancer, and head and neck tumors, and aims to overcome drug resistance mechanisms associated with various anticancer therapies [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression effects in multiple animal models, along with acceptable safety profiles [1] Group 2 - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) of China, and it 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 clinical trial application for a multi-cohort combination therapy involving JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]