百利天恒(688506.SH)发布公告，近日，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(注射用iza-bren)被国家药品监督管理局药品审评中心 (简称"CDE")纳入优先审评品种名单。根据公开资料查询，iza-bren也是全球首个被纳入优先审评品种名 单的EGFR×HER3双抗ADC。 ...

公告显示，截至目前，iza-bren治疗既往经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 管鳞癌已被CDE纳入突破性治疗品种名单，并且用于治疗食管鳞癌III期临床的期中分析已达到无进展生 存期(PFS)和总生存期(OS)双主要终点。iza-bren已有2项适应症被CDE纳入优先审评品种名单。 北京商报讯(记者丁宁)1月6日晚间，百利天恒(688506)发布公告称，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(注射用iza-bren)被国家药 品监督管理局药品审评中心(以下简称"CDE")纳入优先审评品种名单。根据公开资料查询，iza-bren也是 全球首个被纳入优先审评品种名单的EGFR×HER3双抗ADC。 ...

智通财经APP讯，百利天恒(688506.SH)发布公告，近日，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(注射用iza-bren)被国家药品监督管理 局药品审评中心(简称"CDE")纳入优先审评品种名单。根据公开资料查询，iza-bren也是全球首个被纳入 优先审评品种名单的EGFR×HER3双抗ADC。 ...

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]

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]

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has received the acceptance notice from the National Medical Products Administration for its innovative drug, iza-bren, which is the world's first EGFR×HER3 dual-target ADC entering Phase III clinical trials [1][2] Group 1: Drug Information - The drug name is BL-B01D1/iza-bren, and it is an injectable formulation [1] - The intended indication is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including one line containing platinum, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] - Iza-bren is recognized as a first-in-class and new concept drug, and it is the only EGFR×HER3 dual-target ADC to have its marketing application accepted [2] Group 2: Clinical Trials and Regulatory Status - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [2] - Seven indications for iza-bren have been included in the breakthrough therapy list by the CDE, and one indication has been designated as a priority review product [2]

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]

Core Viewpoint - The company, Baillie Gifford, announced that its self-developed first-in-class 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 [1] Group 1: Clinical Trial Results - Iza-bren is the first ADC drug to achieve positive results for both PFS and OS in a Phase III clinical study for esophageal cancer [1] - The trial targets patients with recurrent or metastatic esophageal squamous cell carcinoma who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1] Group 2: Regulatory Status - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] - Seven indications for iza-bren have been included in the breakthrough therapy list by the National Medical Products Administration in China, and one indication has been recognized by the U.S. Food and Drug Administration as a breakthrough therapy [1]