Iza-bren是全球首创(First-in-class)、新概念(Newconcept)且唯一进入III期临床阶段的EGFR×HER3双抗 ADC，iza-bren正在中国和美国进行40余项针对多种肿瘤类型的临床试验。截至目前，iza-bren已有7项 适应症被国家药品监督管理局药品审评中心纳入突破性治疗品种名单，1项适应症被美国食品药品监督 管理局纳入突破性治疗品种名单。 智通财经APP讯，百利天恒(688506.SH)发布公告，公司自主研发的全球首创(First-in-class)、新概念 (Newconcept)且唯一进入III期临床阶段的EGFR×HER3双抗ADC(iza-bren)在食管鳞癌的III期临床试验(研 究方案编号：BL-B01D1-305)中，经独立数据监查委员会(iDMC)判断，在预设的期中分析中达到无进展 生存期(PFS)和总生存期(OS)双主要终点，适应症为：既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的 复发性或转移性食管鳞癌。这是全球首个ADC药物在食管癌治疗中取得PFS/OS双阳性结果的III期临床 研究。 ...

Core Viewpoint - The company, Bai Li Tian Heng, announced that its self-developed drug, iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration for treating advanced or metastatic urothelial carcinoma patients who have failed previous platinum-based chemotherapy and PD-1/PD-L1 inhibitors [1] Group 1: Drug Development - Iza-bren is a first-in-class, new concept, and the only drug currently in Phase III clinical trials for its indication [1] - The drug has received breakthrough therapy designation for one indication from the U.S. Food and Drug Administration [1] Group 2: Regulatory Milestones - As of now, iza-bren has seven indications included in the breakthrough therapy list by the drug review center [1]

Core Viewpoint - The company has announced that its self-developed drug, iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant milestone in the treatment of advanced or metastatic urothelial carcinoma [1] Group 1 - The drug iza-bren is a first-in-class and new concept EGFR×HER3 dual antibody ADC [1] - It is specifically designed for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed previous platinum-based chemotherapy and PD-1/PD-L1 inhibitors [1] - The drug has successfully entered the Phase III clinical trial stage [1]

Core Viewpoint - The company Baillie Gifford has announced that its self-developed drug, Iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration of China, marking a significant milestone in its clinical development for advanced urothelial carcinoma patients who have failed previous treatments [1] Group 1 - Iza-bren is the world's first-in-class and new concept EGFR×HER3 dual antibody ADC that has reached the Phase III clinical stage [1] - The drug is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] - To date, Iza-bren has had 7 indications included in the breakthrough therapy list by the drug review center, and 1 indication has received breakthrough therapy designation from the U.S. Food and Drug Administration [1]

Core Insights - Iza-bren has demonstrated unprecedented clinical results in treating advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC), with 94% of patients experiencing tumor shrinkage and a median progression-free survival (PFS) of 12.5 months, significantly outperforming existing therapies [1][7] - The drug is a first-in-class dual-target antibody-drug conjugate (ADC) developed by the Chinese company BaiLi Tianheng, which has garnered significant attention and investment from global pharmaceutical giants [5][11] - Iza-bren is currently undergoing over 40 clinical trials across various cancer types in both China and the U.S., with several indications recognized as breakthrough therapies by regulatory authorities [5][8] Company Insights - BaiLi Tianheng has positioned itself as a rising star in the biopharmaceutical industry, with Iza-bren being a cornerstone of its innovative pipeline [9][16] - The company has successfully negotiated a partnership with Bristol-Myers Squibb (BMS) for the co-development of Iza-bren, securing an investment of $8.4 billion, reflecting confidence in the drug's potential [5][11] - BaiLi Tianheng aims to establish itself among the top global pharmaceutical companies, with aspirations to achieve annual sales of $20 billion for Iza-bren, which would place it among the top 20 pharmaceutical companies worldwide [13][14] Industry Insights - ADCs represent the forefront of cancer treatment, and Iza-bren is highlighted as a leading candidate in this category, potentially transforming the treatment landscape for various cancers [5][12] - The global pharmaceutical market is witnessing a shift towards innovative therapies, with ADCs like Iza-bren expected to play a crucial role in addressing unmet clinical needs [8][12] - The success of Iza-bren could pave the way for increased recognition and competitiveness of Chinese biopharmaceutical companies in the global market, challenging the dominance of established multinational corporations [14][16]

Core Insights - The company, Baile Tianheng, announced that its self-developed drug, iza-bren, has been included in the priority review list by the National Medical Products Administration (NMPA) [1] - Iza-bren is the world's first and only EGFR×HER3 dual-targeted antibody-drug conjugate (ADC) to enter Phase III clinical trials [1] - The intended indication for iza-bren is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including at least one platinum-based regimen, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] Company Summary - Baile Tianheng is recognized for its innovative approach in developing the first-in-class dual-targeted ADC, which highlights its commitment to advancing cancer treatment [1] - The inclusion of iza-bren in the priority review list signifies a potential acceleration in the drug's approval process, which could lead to significant market opportunities [1] Industry Context - The development of dual-targeted therapies like iza-bren reflects a growing trend in the oncology field towards more personalized and effective treatment options for complex cancers [1] - The prioritization by regulatory authorities indicates a positive outlook for novel therapies in addressing unmet medical needs in oncology [1]

Core Viewpoint - The company, BaiLi TianHeng, announced that its self-developed EGFR×HER3 dual antibody ADC (iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) of China, marking it as the first of its kind to enter Phase III clinical trials and receive priority review status [1] Group 1 - The drug, iza-bren, is the first EGFR×HER3 dual antibody ADC globally to be included in the priority review list [1] - Iza-bren has been recognized as a breakthrough therapy for recurrent or metastatic nasopharyngeal carcinoma that has failed at least two lines of chemotherapy and prior PD-1/PD-L1 monoclonal antibody treatment [1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met its primary endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1]

Core Viewpoint - The company announced that its self-developed, first-in-class EGFR×HER3 dual antibody ADC (Iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) in China, marking a significant milestone in its clinical development [1] Group 1 - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1] - The drug is currently undergoing over 40 clinical trials in China and the United States for various types of tumors [1]

Core Viewpoint - The company, Baillie Gifford, has announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC, Iza-bren, has been included in the priority review list by the National Medical Products Administration (NMPA) of China, marking it as the first EGFR×HER3 dual antibody ADC to receive such recognition globally [1][1][1] Group 1 - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials, and it is currently undergoing over 40 clinical trials for various types of tumors in both China and the United States [1][1][1] - The NMPA has included Iza-bren in the list of breakthrough therapy products for the treatment of recurrent or metastatic nasopharyngeal carcinoma, which has previously failed at least two lines of chemotherapy [1][1][1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met the primary research endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1][1][1]

Core Viewpoint - The company announced that its drug Iza-bren has received Breakthrough Therapy Designation from the FDA for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC) after failure of prior EGFR-TKI and platinum-based chemotherapy [1][2]. Group 1: FDA Breakthrough Therapy Designation - Iza-bren, a dual-target antibody-drug conjugate (ADC) targeting EGFR and HER3, has been granted Breakthrough Therapy Designation by the FDA, indicating its potential to significantly outperform existing standard therapies [1][2]. - This designation is based on clinical trial data from studies BL-B01D1-101, BL-B01D1-203 in China, and BL-B01D1-LUNG-101 in the US/Europe, demonstrating promising efficacy and manageable safety in patients with EGFR mutations who progressed after third-generation EGFR-TKIs and platinum chemotherapy [2]. Group 2: Clinical Development and Market Position - Iza-bren is the first-in-class and only ADC targeting EGFR and HER3 that has entered Phase III clinical trials, with over 40 ongoing clinical trials for various tumor types in China and the US [2]. - The drug has five additional indications included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) in China, highlighting its broad potential in oncology [2].