苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG006用于治疗神经内分泌癌获得FDA孤儿药资格认定的公告

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. announced that its injectable ZG006 has received Orphan-drug Designation from the FDA for the treatment of neuroendocrine cancer, which may provide certain policy support for its subsequent development and commercialization in the U.S. [2][5] Group 1: Drug Information - ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody platform, and it has received clinical trial approval from both the FDA and China's NMPA [3]. - ZG006 is the first-in-class molecule targeting DLL3, with potential to become a best-in-class drug, as it connects tumor cells and T cells to enhance tumor cell killing [3]. Group 2: Regulatory and Development Implications - The Orphan-drug Designation allows ZG006 to benefit from various policy supports, including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity [5]. - The company must still engage with the FDA regarding subsequent clinical trials and registration plans, with the success of these efforts remaining uncertain [2][6]. Group 3: Clinical Research Updates - The company presented clinical research data for ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual meeting, indicating ongoing progress in its clinical development [4].