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百利天恒iza-bren用于治疗复发性或转移性食管鳞癌被纳入优先审评程序
Bei Jing Shang Bao· 2026-01-06 09:58
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]
百利天恒(688506) - 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被纳入优先审评程序的公告
2026-01-06 09:30
申请人:成都百利多特生物药业有限责任公司 拟定适应症(或功能主治):本品适用于既往经 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患者。 拟优先审评的理由:经审核,本申请符合《药品注册管理办法》和《国家药 监局关于发布〈突破性治疗药物审评工作程序(试行)〉等三个文件的公告》(2020 年第 82 号)有关要求,同意按优先审评范围"(四)纳入突破性治疗药物程序的 药品"纳入优先审评审批程序。 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被纳入优先审评程序的公告 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")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 ...
百利天恒(688506.SH):iza-bren(EGFR×HER3双抗ADC)用于治疗复发性或转移性食管鳞癌被纳入优先审评程序
Zhi Tong Cai Jing· 2026-01-06 09:08
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]
百利天恒(688506.SH):iza-bren(EGFR×HER3 双抗ADC)用于治疗复发性或转移性食管鳞癌被纳入优先审评程序
Ge Long Hui A P P· 2026-01-06 09:04
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]
百利天恆(688506.SH):iza-bren(EGFR×HER3雙抗ADC)用於治療複發性或轉移性食管鱗癌被納入優先審評程序
智通财经网· 2026-01-06 09:01
Core Viewpoint - The company, Bai Li Tian Heng, has announced that its self-developed drug, iza-bren, a first-in-class EGFR×HER3 dual antibody ADC, has been included in the priority review list by the National Medical Products Administration's Center for Drug Evaluation (CDE) [1] Group 1 - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to enter the Phase III clinical stage [1] - The inclusion in the priority review list signifies a significant milestone for the company and its innovative drug development [1]
宝盈基金姚艺包揽去年12月股基与混基跌幅第一
Zhong Guo Jing Ji Wang· 2026-01-06 07:46
Group 1 - The core point of the article highlights that in December 2025, the worst-performing ordinary equity and mixed funds were both managed by Baoying Fund, specifically the Baoying Medical Health Hong Kong-Shenzhen Stock A and C, which reported returns of -13.20% and -13.26% respectively [1] - The Baoying Innovation Medical Mixed Initiation A and C funds also performed poorly, with returns of -14.14% and -14.19%, making them the worst in the mixed fund category [1] - All these funds are themed around the medical sector and are managed by the same fund manager, Yao Yi, who has a background in research and fund management [1] Group 2 - The latest quarterly report indicates that the top ten holdings of the Baoying Medical Health Hong Kong-Shenzhen Stock fund include major companies such as Innovent Biologics, Kelun Pharmaceutical, and others, while the Baoying Innovation Medical Mixed Initiation fund shares many of the same top holdings [1][2] - Notably, several of these top holdings experienced significant declines in December, with the largest holding, Innovent Biologics, dropping by 18.97%, and another major holding, 3SBio, declining by over 22% [2] - The performance metrics of the funds show that the Baoying Innovation Medical Mixed Initiation C has a cumulative net value of 0.8857 and a scale of 0.51 billion, while the A share has a cumulative net value of 0.8886 and a scale of 0.47 billion [3]
智通A股限售解禁一览|1月6日
智通财经网· 2026-01-06 01:03
Core Viewpoint - On January 6, a total of 10 listed companies had their restricted shares unlocked, with a total market value of approximately 49.768 billion yuan [1] Group 1: Companies and Their Unlocking Details - Aishuxin Co., Ltd. (爱旭股份) had 227 million shares unlocked, categorized as newly issued A-shares for institutional placement [1] - Xinwufeng Co., Ltd. (新五丰) had 244 million shares unlocked, also categorized as newly issued A-shares for institutional placement [1] - Dun'an Environment Co., Ltd. (盾安环境) had 139 million shares unlocked, categorized as newly issued A-shares for institutional placement [1] - Pulite Co., Ltd. (普利特) had 988,300 shares unlocked, categorized as shares from equity incentive plans [1] - Samsung Medical (三星医疗) had 2.1793 million shares unlocked, categorized as shares from equity incentive plans [1] - Kailong Co., Ltd. (凯龙股份) had 174,900 shares unlocked, categorized as shares from equity incentive plans [1] - Shengbang Co., Ltd. (盛帮股份) had 30.662 million shares unlocked, categorized as extended lock-up period shares [1] - Yujing Co., Ltd. (宇晶股份) had 26 million shares unlocked, categorized as newly issued A-shares for institutional placement [1] - Zhongyi Technology (中亦科技) had 53.145 million shares unlocked, categorized as extended lock-up period shares [1] - Baili Tianheng (百利天恒) had 30.9 million shares unlocked, with no specific category mentioned [1]
百利天恒12月31日获融资买入894.29万元,融资余额3.50亿元
Xin Lang Cai Jing· 2026-01-05 01:54
12月31日,百利天恒涨0.14%,成交额2.20亿元。两融数据显示,当日百利天恒获融资买入额894.29万 元,融资偿还2943.23万元,融资净买入-2048.94万元。截至12月31日,百利天恒融资融券余额合计3.54 亿元。 融资方面,百利天恒当日融资买入894.29万元。当前融资余额3.50亿元,占流通市值的1.05%,融资余 额超过近一年90%分位水平,处于高位。 融券方面,百利天恒12月31日融券偿还400.00股,融券卖出672.00股,按当日收盘价计算,卖出金额 21.71万元;融券余量1.20万股,融券余额387.59万元,超过近一年70%分位水平,处于较高位。 资料显示,四川百利天恒药业股份有限公司位于四川省成都市温江区成都海峡两岸科技产业园百利路 161号一幢一号,香港湾仔皇后大道东183号合和中心46楼,成立日期2006年8月17日,上市日期2023年1 月6日,公司主营业务涉及药品的研发、生产及销售。主营业务收入构成为:在某一时点确认99.57%, 在某一时段内确认0.43%。 责任编辑:小浪快报 截至9月30日,百利天恒股东户数5979.00,较上期增加25.08%;人均流通股1 ...
A股1月逾2800亿元解禁,百利天恒、海博思创解禁规模居前
Group 1 - In January 2026, a total of 117 companies will have their restricted shares unlocked, amounting to approximately 10.202 billion shares and a total market value of 289.587 billion yuan, which is a decrease of about 14.13% month-on-month and an increase of approximately 12.57% year-on-year [1][2][4] - The company with the largest unlock scale is Baili Tianheng, with a market value exceeding 90 billion yuan [1][4] - The top three industries by unlock market value are pharmaceuticals and biotechnology, electrical equipment, and automotive [1][9] Group 2 - In January, 12 companies will have their anniversary unlocks, totaling approximately 1.028 billion shares and a market value of 54.824 billion yuan, including companies like Haibo Sichuang, Xingtou Measurement and Control, and Saifen Technology [1][11] - The second largest unlock scale is for Haibo Sichuang, with 9.464 million shares and a market value of approximately 23.937 billion yuan, accounting for about 52.55% of its total share capital [4][8] - Guolian Minsheng ranks third in unlock market value, with 1.771 billion shares, representing 31.17% of its total share capital and a market value of approximately 18.132 billion yuan [8]
特朗普威胁委内瑞拉代总统:若不正确行事,将付出更惨痛代价;丹麦首相:美国应停止继续威胁“吞并格陵兰岛”;2026年育儿补贴今天开始申领丨早报
Di Yi Cai Jing· 2026-01-05 00:31
Group 1 - The U.S. President Trump threatened the acting President of Venezuela, Rodriguez, stating that if she does not act correctly, she may face a heavier price than President Maduro [1] - The Danish Prime Minister urged the U.S. to stop threatening to annex Greenland, asserting that such discussions are meaningless [1] Group 2 - The Chinese automotive exports to Venezuela increased by 130% in the first 11 months of 2025, with passenger car exports rising by 166% and truck exports by 99% [6] - The U.S. government has requested American oil companies to invest heavily in Venezuela to restore its oil extraction infrastructure, indicating a push for revitalization of the oil industry [9] Group 3 - The Ministry of Education in China announced plans to establish 15 new undergraduate higher education institutions [4] - The Ministry of Finance in China stated that the issuance of ultra-long-term general government bonds will start on January 14, 2026 [5] Group 4 - The Shanghai government released a plan with 26 measures to optimize the business environment, focusing on efficient government services and fair market competition [7] - The global protests against U.S. military intervention in Venezuela occurred in various countries, condemning U.S. actions and interventionism [8]