苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG005与含铂化疗联用获得药物临床试验批准通知书的公告

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005 in combination with platinum-based chemotherapy for advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma [2] Group 1: Drug Information - Injectable ZG005 is a recombinant humanized dual-specificity antibody targeting PD-1 and TIGIT, classified as a Class 1 innovative tumor immunotherapy biological product, with potential applications for various solid tumors [3] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [3] - The drug works by blocking both PD-1 and TIGIT pathways, enhancing T cell and NK cell activation and proliferation, thereby improving the immune system's ability to kill tumor cells [3] Group 2: Clinical Trial Approval Impact - The approval of the clinical trial for ZG005 in combination with platinum-based chemotherapy is not expected to have a significant impact on the company's recent performance [2] - The drug development process is lengthy and complex, involving high costs and multiple approval stages, which are subject to various uncertainties [2]