Group 1 - The core viewpoint of the article is that Hongyuan Green Energy is forecasting a significant improvement in its financial performance for the year 2025, expecting a net profit attributable to shareholders of the parent company between 180 million and 250 million yuan, indicating a turnaround from a loss to profit compared to the previous year [2] Group 2 - The company anticipates achieving profitability in 2025, which marks a notable recovery from its previous financial performance [2] - The projected net profit range reflects a positive outlook for the company's operations and financial health moving forward [2] - The announcement is based on statutory disclosure data from the previous year, highlighting the company's commitment to transparency in its financial reporting [2]

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC, Iza-bren, which is the only one to enter Phase III clinical trials globally [1][2] Group 1: Drug Development and Clinical Trials - Iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma, 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, and Iza-bren has been included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1] Group 2: Regulatory Status and Breakthrough Designations - Iza-bren is the first EGFR×HER3 dual antibody ADC to have its drug application accepted globally and is currently undergoing over 40 clinical trials for various tumor types in China and the United States [2] - As of now, Iza-bren has seven indications included in the breakthrough therapy designation list by the NMPA, two indications in the priority review list, and one indication recognized by the U.S. Food and Drug Administration (FDA) as a breakthrough therapy [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 acceptance of the New Drug Application (NDA) for the innovative drug iza-bren (BL-B01D1) by the National Medical Products Administration (NMPA) marks a significant milestone for the company and indicates a shift in China's role in the global pharmaceutical landscape from a follower to a key innovator and competitor in the dual-target antibody-drug conjugate (ADC) space [1][3][10] Group 1: Drug Development and Regulatory Milestones - The drug iza-bren has received NDA acceptance for two indications within two months, showcasing its rapid progress towards commercialization [1] - The drug targets recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed prior PD-1/PD-L1 therapy, addressing a significant unmet clinical need [3][4] - The drug has achieved positive results in pivotal Phase III clinical trials, being the first ADC to demonstrate positive outcomes in both progression-free survival (PFS) and overall survival (OS) in the esophageal cancer domain [4][5] Group 2: Clinical Evidence and Market Potential - The drug's clinical evidence is robust, with a Phase III study demonstrating significant anti-tumor activity and safety, further validated by its recognition in top-tier journals [4] - The drug's acceptance into priority review by the CDE is expected to expedite its market entry, allowing Chinese patients to benefit from this innovative treatment approximately three years ahead of the global market [3][4] - The company has established a broad clinical trial network, with over 40 ongoing trials in various cancers, indicating a strong potential for broad-spectrum anti-cancer applications [7] Group 3: Strategic Collaborations and Future Growth - The collaboration with Bristol-Myers Squibb (BMS) for up to $8.4 billion underscores the global recognition and potential of iza-bren, marking a significant milestone for Chinese innovation in the pharmaceutical industry [8] - The company is positioned to fill clinical gaps in multiple cancer types, with a clear commercialization strategy that includes both second-line and first-line treatment options [9] - The company has developed a multi-platform innovation engine, which includes ADC, GNC, and ARC technologies, ensuring a continuous pipeline of groundbreaking drugs beyond iza-bren [9][10]

Core Viewpoint - The acceptance of the new drug application (NDA) for the innovative dual-target antibody-drug conjugate (ADC) drug, iza-bren (BL-B01D1), by the National Medical Products Administration (NMPA) marks a significant milestone for the company and represents a shift in China's role in global pharmaceutical innovation [1][4][12]. Group 1: Drug Development and Regulatory Milestones - The drug iza-bren has received NDA acceptance for two indications within two months, first for nasopharyngeal cancer and now for esophageal squamous cell carcinoma [1]. - The drug has been included in the priority review process by the Center for Drug Evaluation (CDE), which will expedite its market entry [5]. - Iza-bren is the first ADC to achieve positive results in both progression-free survival (PFS) and overall survival (OS) in a Phase III trial for esophageal cancer, highlighting its potential as a groundbreaking treatment [5][6]. Group 2: Clinical Need and Market Opportunity - Esophageal cancer is a major health issue in China, with approximately 224,000 new cases annually, accounting for 43.8% of global cases [4]. - Current treatment options for advanced esophageal squamous cell carcinoma are limited, particularly after the failure of first-line therapies, creating a significant unmet clinical need [4]. - Iza-bren aims to address this gap by providing a new treatment option for patients who have failed prior PD-1/PD-L1 therapy [4]. Group 3: Strategic Value and Competitive Advantage - The dual-target mechanism of iza-bren, which targets both EGFR and HER3, enhances its efficacy and reduces off-target toxicity, establishing a scientific basis for its broad anti-tumor potential [8]. - The company has over 40 ongoing clinical trials in the U.S. and China, covering various cancers, which demonstrates its extensive clinical development strategy [8]. - A significant partnership with Bristol-Myers Squibb (BMS) worth up to $8.4 billion underscores the global recognition and potential of iza-bren [9]. Group 4: Future Growth and Innovation - The commercialization strategy for iza-bren includes filling clinical gaps in esophageal and nasopharyngeal cancers, as well as exploring its use in combination with existing therapies for broader indications [10]. - The company has developed a robust innovation engine with multiple platforms, ensuring a continuous pipeline of new drugs beyond iza-bren [10]. - The success of iza-bren represents a broader trend of Chinese pharmaceutical companies moving from imitation to original innovation, marking a new era in China's pharmaceutical industry [12].

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]

证券代码：688506 证券简称：百利天恒 公告编号：2026-007 四川百利天恒药业股份有限公司 自愿披露关于 iza-bren（EGFR×HER3 双抗 ADC）用于治疗 复发性或转移性食管鳞癌的药品上市申请获得受理的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 近日，四川百利天恒药业股份有限公司（以下简称"公司"）收到国家药品 监督管理局药品审评中心（CDE）核准签发的《受理通知书》，公司自主研发的 全球首创（First-in-class）、新概念（New concept）且唯一进入 III 期临床阶段的 EGFR×HER3 双抗 ADC（iza-bren）的药品上市申请（NDA）已获得正式受理。 此前，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。本次 NDA 受理是基于该 III 期临床试 验的期中分析结果，iza-bren 用于治疗复发性 ...

Core Viewpoint - The company Baili Tianheng (688506) has received a formal acceptance notice from the National Medical Products Administration (NMPA) for its drug application of the EGFR×HER3 dual antibody ADC (iza-bren), indicating progress towards market approval [1] Group 1: Drug Development and Approval - The drug application (NDA) for iza-bren has been officially accepted based on the interim analysis results from a Phase III clinical trial for esophageal squamous cell carcinoma [1] - The independent data monitoring committee (iDMC) determined that the trial met its primary endpoints of progression-free survival (PFS) and overall survival (OS) during the pre-specified interim analysis [1] - Iza-bren has been included in the priority review list by the NMPA 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]