东北制药(000597.SZ)：DCTY0801注射液临床试验获批

Core Viewpoint - Northeast Pharmaceutical (000597.SZ) announced that its subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received approval from the National Medical Products Administration for a clinical trial of DCTY0801 injection, targeting EGFRvIII positive recurrent or progressive high-grade glioma [1][2] Group 1: Company Developments - The DCTY0801 injection is a CAR-T cell product targeting the EGFRvIII mutation, which is present only in tumor cells and not in normal tissues [2] - Approximately 30% of glioblastoma patients have the EGFRvIII mutation, indicating a significant patient population for this treatment [2] - The development of CAR-T therapy targeting EGFRvIII is expected to provide a solution for the treatment of glioblastoma, where current immunotherapy options are limited [2] Group 2: Regulatory and Market Implications - DCTY0801 injection received orphan drug designation from the FDA in May 2023, which allows for expedited review, a seven-year exclusivity period post-approval, and tax incentives in the U.S. [2] - The orphan drug status is highly valuable for the drug's market launch and global promotion [2]