华东医药创新药又获进展 肿瘤管线临床申请获FDA批准

Core Insights - Company East China Pharmaceutical has received FDA approval for its clinical trial application of HDM2012, a novel antibody-drug conjugate targeting MUC-17 for advanced solid tumors [1][2] - HDM2012 is a first-in-class biologic with global intellectual property rights, demonstrating good drug-like properties, safety, and efficacy in preclinical studies [1][2] - The ADC market is projected to grow significantly, with global sales expected to reach $64.7 billion by 2030, reflecting a compound annual growth rate of 30% [2] Company Developments - The clinical trial application for HDM2012 was submitted to the FDA in May 2025 and received approval shortly thereafter, with a similar application accepted in China in June 2025 [2] - East China Pharmaceutical has previously launched other ADC products, including the first-in-class drug Somatuzumab Injection, which received conditional approval in November 2024 [3] - The approval of HDM2012's clinical trial is a significant advancement in the company's R&D process, enhancing its competitiveness in the oncology treatment sector [3]