Core Insights - The EGFR x HER3 dual antibody ADC iza-bren (BL-B01D1) developed by Bai Li Tianheng has received multiple significant approvals and recognitions in September 2023, indicating its potential as a breakthrough treatment in oncology [1][2][3] Group 1: Regulatory Approvals - On September 5, 2023, iza-bren was officially included in the priority review list by the National Medical Products Administration (NMPA) for treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed at least two lines of chemotherapy [1] - On September 10, 2023, iza-bren was listed as a breakthrough therapy for treating platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [2] - On September 17, 2023, iza-bren was proposed for inclusion as a breakthrough therapy for locally advanced or metastatic urothelial carcinoma patients who have failed prior platinum-based chemotherapy and PD-1/PD-L1 inhibitors, marking its seventh breakthrough therapy designation in China [2] Group 2: Clinical Research Achievements - Two studies of iza-bren were selected for the official news release program of the 2025 World Lung Cancer Conference (WCLC), showcasing the highest-rated research outcomes [1] - The Phase II study of iza-bren combined with Osimertinib for treating advanced or metastatic EGFR-mutant non-small cell lung cancer reported an overall response rate (ORR) of 100%, marking it as the first treatment regimen globally to achieve such a result [1] - In October 2023, iza-bren's first registered Phase III clinical trial results will be presented at the European Society for Medical Oncology (ESMO) annual meeting, with the results included in the prestigious Late-breaking Abstract (LBA) session [3] Group 3: Collaborative Efforts - Tai Mei Medical Technology has provided various digital clinical research solutions for the series of studies related to iza-bren, supporting the advancement of Chinese innovative drugs on the global stage [3] - The independent efficacy evaluation of the Phase II study of iza-bren was efficiently conducted using AI and digital systems, demonstrating the capabilities of Tai Mei Medical Technology in supporting clinical research [3]