上海君实生物医药科技股份有限公司 自愿披露关于JS212临床试验申请获得FDA批准的公告

Group 1 - The company has received FDA approval for its dual-specificity antibody-drug conjugate JS212, aimed at treating advanced solid tumors [1] - JS212 targets both EGFR and HER3, which are highly expressed in various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression in multiple animal models [1] Group 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 has also been approved by the National Medical Products Administration, with plans to initiate related clinical research soon [2]