Core Viewpoint - The company, Baili Tianheng, has announced the completion of the first patient enrollment in a Phase III clinical trial for its first-in-class EGFR×HER3 dual-targeted antibody-drug conjugate (ADC), iza-bren, aimed at platinum-resistant recurrent epithelial ovarian cancer patients [1] Group 1 - The Phase III clinical trial for iza-bren is the only one of its kind that has entered this stage globally [1] - Currently, iza-bren is involved in over 40 clinical trials targeting various tumor types in both China and the United States [1] - In addition to the newly enrolled trial, iza-bren is also in the patient enrollment phase for nine domestic Phase III registration clinical trials, including those for non-small cell lung cancer, small cell lung cancer, breast cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and urothelial carcinoma [1]

Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry [1][12]. Core Insights - The report highlights the promising efficacy of iza-bren in treating NSCLC and SCLC, showcasing significant results in various clinical trials [2][5]. - Iza-bren is a dual-targeted antibody-drug conjugate (ADC) that combines EGFR and HER3, demonstrating a unique mechanism to overcome drug resistance [2][4]. - The report emphasizes the ongoing clinical trials in both China and the United States, with approximately 30 trials and 10 Phase III studies currently in progress [2][3]. Summary by Sections Drug Evaluation - Iza-bren shows remarkable efficacy in NSCLC patients with an overall response rate (ORR) of 52.0% and a disease control rate (DCR) of 86.7% in a Phase I trial [3]. - In patients with EGFR wild-type NSCLC, the ORR is 50.0% and the DCR is 80.8% [3]. - For EGFR-mutated NSCLC patients, the ORR reaches 63.2% with a DCR of 89.5% [3]. Efficacy in SCLC - In extensive-stage SCLC patients, iza-bren demonstrates an ORR of 55.2% and a median overall survival (mOS) of 12.0 months [5]. - Among patients who previously received only one line of PD-(L)1 inhibitor therapy, the ORR is 80.0% with an mOS of 15.0 months [5]. Safety Profile - The safety profile of iza-bren is manageable, with a treatment-related adverse event (TRAE) discontinuation rate of 2.4% [6][9]. - The most common hematological TRAEs include anemia (84.5%) and leukopenia (74.1%) [6].