Policy Developments - The National Medical Products Administration (NMPA) has expanded the scope of export certificates for pharmaceuticals, allowing companies to apply for export certificates for drugs produced under GMP, regardless of whether they are approved for sale in China [2] - The validity period for the "Drug Export Sales Certificate" has been extended from 2 years to 3 years, aligning it with the "Export Certificate for EU Raw Materials" [2] - The maximum processing time for export certificates has been set at 20 working days, excluding the time required for technical reviews and on-site inspections [2] Drug and Device Approvals - Heng Rui Medicine has received clinical trial approval notices for multiple drugs, including SHR-9839 and SHR-A2009, and will soon commence clinical trials [4] - Renfu Medicine's application for the marketing authorization of Dexmethylphenidate Capsules has been accepted, targeting ADHD treatment, marking a significant step as no similar products are currently available in China [5] - Baile Tianheng's innovative EGFR×HER3 dual-target ADC drug, iza-bren, has had its marketing application accepted, being the first of its kind to enter Phase III clinical trials [6] Capital Markets - Eli Lilly has become the first healthcare company to reach a market capitalization of $1 trillion, with its stock price increasing by 38% this year, driven by investor optimism regarding its weight-loss drug [8] - Changshan Pharmaceutical's controlling shareholder plans to transfer 5% of its shares to Element Fund at a price of 46.25 yuan per share, totaling 2.1275 billion yuan [9][10] Industry Events - A medical representative was sentenced to eight months in prison for fraudulently altering gene test reports to defraud health insurance, highlighting the increasing scrutiny and regulatory measures in the pharmaceutical industry [12] - Heng Rui Medicine has signed a partnership agreement with the Hong Kong Greater China Cancer Foundation to provide innovative therapies for breast cancer patients in Hong Kong [13] - Baicheng Medicine has entered into an exclusive licensing agreement with Zhongshen Innovation for the innovative drug BIOS-0629 in the Greater China region, with milestone payments of 300 million yuan [14] Public Opinion Alerts - Li Xin, former member of the Party Committee and assistant general manager of China Pharmaceutical Health Industry Co., is under investigation for serious violations of discipline and law [16]

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。 登录新浪财经APP 搜索【信披】查看更多考评等级 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。 本次受理是基于BL-B01D1-303研究的期中分析结果。此前，公司已与国家药品监督管理局药品审评中 心（CDE）顺利完成新药上市申请前会议（Pre-NDA）沟通交流，iza-bren用于治疗局部晚期或转移性 鼻咽癌已被CDE纳入优先审评品种名单。现将相关情况公告如下： 一、药品的基本情况 药品名称：注射用BL-B01D1/iza-bren 根据我国药品注册相关的法律法规要求，药品在获得上市申请受理后，尚需通过国家药品监督管理局相 关审评程序并获批准后方可上市、销售。 由于医药产品具有高科技、高风险、高附加值的特点，药品 ...

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its self-developed EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China [1] Group 1: Product Development - Iza-bren is the world's first-in-class and new concept EGFR×HER3 dual antibody ADC, and it is the only one that has entered Phase III clinical trials globally [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various types of tumors [1] Group 2: Regulatory Milestones - As of now, Iza-bren has seven indications included in the CDE's list of breakthrough therapy products and one indication included in the priority review list by CDE [1] - Additionally, one indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]

Core Insights - Baillie Tianheng (688506.SH) announced that its self-developed, globally first and unique EGFR×HER3 dual antibody ADC (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 (ESCC) [1][2] - This marks the first ADC drug to achieve positive PFS/OS results in the treatment of esophageal cancer in a Phase III clinical study [1] Group 1 - The independent data monitoring committee confirmed that iza-bren met the predefined interim analysis criteria for PFS and OS compared to chemotherapy [1] - The indication for iza-bren has been included in the breakthrough therapy list by the CDE, with a pre-market communication application submitted recently, expecting commercialization in China next year [1] Group 2 - In early clinical trials for advanced esophageal squamous cell carcinoma, iza-bren demonstrated excellent data, with an overall response rate (ORR) of 32.9% among 73 evaluable patients out of 82 [2] - Safety analysis indicated that the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 58.5%, with the most common being anemia (28.0%), leukopenia (15.9%), and thrombocytopenia and neutropenia (both 14.6%) [2] - Iza-bren has also met the standards in trials for nasopharyngeal carcinoma and plans to release data at ESMO 2025, with upcoming applications for lung cancer and breast cancer indications [2]

Core Insights - Baili Tianheng (688506.SH) announced that its self-developed, globally first and only EGFR×HER3 dual-targeted ADC (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 (ESCC) [1] - The trial specifically targets patients with recurrent or metastatic ESCC who have previously failed PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] - The drug has been included in the breakthrough therapy list by the CDE, and the company has submitted a pre-market communication application, expecting commercialization in China next year [1] Clinical Trial Results - The interim analysis of the BL-B01D1-305 study showed that iza-bren achieved both PFS and OS endpoints compared to chemotherapy [1] - In early clinical trials involving 82 ESCC patients, the overall objective response rate (ORR) was 32.9%, with 73 patients eligible for efficacy evaluation [2] - The safety analysis indicated that the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 58.5%, with the most common being anemia (28.0%), leukopenia (15.9%), and thrombocytopenia and neutropenia (both 14.6%) [2] Future Developments - The treatment for nasopharyngeal carcinoma has also met its trial goals, with plans to present data at ESMO 2025 [2] - The company is preparing to apply for market approval for indications in nasopharyngeal carcinoma and esophageal squamous cell carcinoma, with additional applications for lung cancer and breast cancer expected to follow [2]

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。 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。 ...

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]