苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG006与依托泊苷及顺铂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 ZG006 in combination with etoposide and cisplatin for advanced neuroendocrine cancer [2][5] Group 1: Drug Information - ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform [3] - ZG006 has received clinical trial permits from both the FDA in the United States and the NMPA in China, and has been designated as a breakthrough therapy by the NMPA and an orphan drug by the FDA [3] - ZG006 targets two different DLL3 epitopes and CD3, acting as a T-cell engager that connects T-cells to tumor cells, showing significant tumor suppression in preclinical studies [3] Group 2: Clinical Trial Approval - The clinical trial approval for ZG006 in combination with etoposide and cisplatin is specifically for advanced neuroendocrine cancer [2] - The approval is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5] Group 3: Recent Developments - The company presented clinical research data and updates on ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual meeting [4]