东北制药：DCTY0801注射液获临床试验批准

Core Viewpoint - Northeast Pharmaceutical (000597) announced that Beijing Dingcheng Peptide Source Biotechnology Co., Ltd. received the approval from the National Medical Products Administration for the clinical trial of DCTY0801 injection for EGFRvIII positive recurrent or progressive high-grade glioma [1] Summary by Relevant Sections - Product Development - DCTY0801 injection is a CAR-T cell product targeting the EGFRvIII mutation antigen, which received orphan drug designation from the FDA in May 2023 [1] - Clinical Trial Approval - The approval of the clinical trial is a significant milestone in the product's development, enhancing the company's core competitiveness in the oncology treatment field [1] - Financial Impact - There is no significant short-term impact on the company's performance, but drug development is characterized by high investment, high risk, and long cycles, leading to uncertainties in clinical trial progress and results [1]