在预设的期中分析中，顶线结果显示，与医生选择的化疗方案相比，iza-bren在无进展生存期(PFS)及总 生存期(OS)均获得具有统计学意义和临床意义的显著改善，研究成功达到双重主要终点。 这项研究是iza-bren达到主要终点的第3项III期临床研究。在三阴性乳腺癌中，iza-bren是全球首个在III 期研究中报告PFS和OS双阳性结果的双抗ADC药物。 iza-bren (BL-B01D1)是全球首创(First-in-class)、新概念(New concept)且率先进入唯一进入III期临床试验 阶段的EGFR×HER3双抗ADC。截至2026年1月，百利天恒与战略合作伙伴BMS正在就iza-bren开展40余 项针对多种肿瘤类型的临床试验： 美国华盛顿州雷德蒙德&新泽西州普林斯顿——SystImmune, Inc.(简称"SystImmune")与Bristol Myers Squibb(简称"BMS")共同宣布：SystImmune母公司四川百利天恒药业股份有限公司(简称"百利天恒")公布 了一项III期临床研究(BL-B01D1-307)的预设期中分析取得积极顶线结果。该项研究评估iza- b ...

Core Viewpoint - The company announced significant progress in the Phase III clinical trial of iza-bren for locally advanced or metastatic triple-negative breast cancer, with the independent data monitoring committee recommending early regulatory submission based on interim analysis results [1] Group 1: Clinical Trial Progress - The topline data indicates that iza-bren significantly extends progression-free survival (PFS) and overall survival (OS), achieving both primary endpoints [1] - This marks the third Phase III clinical trial where the dual antibody ADC has reached its primary endpoints [1] Group 2: Regulatory Status - As of now, iza-bren has seven indications included in the breakthrough therapy list by the National Medical Products Administration (NMPA) and one indication by the U.S. Food and Drug Administration (FDA) [2] - Two indications for iza-bren, targeting locally advanced or metastatic nasopharyngeal carcinoma and recurrent or metastatic esophageal squamous cell carcinoma, have had their New Drug Applications (NDA) accepted by the NMPA and are in the priority review process [2] Group 3: Development and Market Considerations - The company emphasizes that drug registration requires completion of relevant clinical trials and approval from the NMPA before market launch, highlighting the lengthy and complex nature of the drug development process [2] - The company will actively promote the aforementioned research projects and comply with information disclosure obligations regarding project progress [2]

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its innovative EGFR×HER3 dual antibody ADC (iza-bren), marking a significant milestone in the treatment of recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy [1] Group 1 - The drug is the world's first-in-class and is currently the only one in Phase III clinical trials [1] - The acceptance of the NDA was granted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration [1] - The drug is specifically designed for patients who have previously undergone treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1]

Core Viewpoint - The company has received formal acceptance for the New Drug Application (NDA) of its self-developed, globally innovative EGFR×HER3 dual antibody ADC, which is the only one to enter Phase III clinical trials [1] Group 1 - The drug, named iza-bren, has achieved dual primary endpoints of progression-free survival and overall survival in a Phase III clinical trial for esophageal squamous cell carcinoma, as determined by an independent data monitoring committee during a pre-set interim analysis [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial [1] - Iza-bren has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]

Core Viewpoint - The company, Baili Tianheng (688506.SH), has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China, marking a significant milestone in the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren is the first EGFR×HER3 dual antibody ADC to have its NDA accepted globally [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) in China [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] Group 2 - As of now, iza-bren has seven indications included in the CDE's list of breakthrough therapy designations [1] - Two indications have been included in the CDE's priority review list [1] - One indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]

Core Viewpoint - The company has received formal acceptance for the New Drug Application (NDA) of its first-in-class, new concept, and only EGFR×HER3 dual antibody ADC (iza-bren), which is currently in Phase III clinical trials for esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial, as determined by an independent data monitoring committee (iDMC) [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial (study protocol number: BL-B01D1-305) [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]

Core Viewpoint - Bailitianheng (688506.SH) announced that its self-developed, first-in-class, new concept, and the only EGFR×HER3 dual-target ADC (injectable iza-bren) has been included in the priority review list by the National Medical Products Administration's Center for Drug Evaluation (CDE) [1] Group 1 - The drug iza-bren is the first EGFR×HER3 dual-target ADC globally to be included in the priority review list [1]

Core Viewpoint - Baili Tianheng (688506) announced that its self-developed, first-in-class EGFR×HER3 dual antibody ADC (injectable iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1 - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1] - As of now, iza-bren has been recognized as a breakthrough therapy for recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] - The interim analysis for the Phase III clinical trial of iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) [1] Group 2 - Iza-bren has two indications that have been included in the priority review list by the NMPA [1]

Core Viewpoint - Bailitianheng (688506.SH) has announced that its self-developed, first-in-class, and new concept EGFR×HER3 dual antibody ADC (injectable iza-bren) has been included in the priority review list by the National Medical Products Administration's Center for Drug Evaluation (CDE) [1] Group 1 - The drug iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1]

Core Viewpoint - Baili Tianheng (688506.SH) announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC (injectable iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1] - The proposed indication for iza-bren is for patients with recurrent or metastatic esophageal squamous cell carcinoma who have failed previous treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1] Group 2: Clinical Progress - As of now, iza-bren has been included in the breakthrough therapy list by the CDE for treating recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody therapy [1] - The interim analysis of the Phase III clinical trial for treating esophageal squamous cell carcinoma has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) [1] - Iza-bren has two indications that have been included in the priority review list by the CDE [1]