Core Insights - China National Pharmaceutical Group's self-developed drug TQB2102 has been included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA) for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed previous treatments with oxaliplatin, irinotecan, and fluorouracil [1][2] - TQB2102 is a dual-targeting antibody-drug conjugate (ADC) that targets HER2 protein ECD2 and ECD4 non-overlapping epitopes, showing significant efficacy in colorectal cancer treatment [1] - Preliminary data from the Phase I clinical trial presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicates an objective response rate (ORR) of 34.8% in patients with HER2 high expression (HER2 IHC 3+) [1] Industry Context - There is currently a lack of specific targeted treatment options for advanced colorectal cancer with HER2 overexpression, with existing second-line treatments showing low efficacy [2] - The objective response rate (ORR) for third-line treatment options is only 1.0%-2.0%, with progression-free survival (PFS) ranging from 1.9 to 3.7 months and overall survival (OS) between 6.4 to 7.4 months, highlighting the urgent need for effective treatment solutions [2] - The inclusion of TQB2102 in the BTD program is expected to accelerate its market entry, potentially transforming the treatment landscape for HER2 IHC 3+ colorectal cancer [2]