Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has obtained a loan commitment of up to 180 million RMB from Bank of China Sichuan Branch to support its share repurchase plan [1][3]. Group 1: Share Repurchase Plan - The company approved a share repurchase plan on December 30, 2025, intending to use self-owned and/or self-raised funds to repurchase A-shares through centralized bidding, with a total repurchase amount between 100 million RMB and 200 million RMB, and a maximum repurchase price of 546 RMB per share [2]. - The repurchase period is set for 12 months from the date of the board's approval, with the repurchased shares planned for future employee stock ownership plans or equity incentives [2]. Group 2: Loan Commitment Details - The loan commitment specifies that the funds are to be used exclusively for the repurchase of company shares, with a loan term of three years [3]. - The actual details of the loan will be formalized in a stock repurchase loan contract between the company and the bank [3]. Group 3: Additional Notes - The loan commitment enhances the flexibility of the company's repurchase funds and reflects the financial institution's recognition of the company's growth prospects [4]. - The company clarifies that the loan does not guarantee the total repurchase amount, and the actual number of shares repurchased will depend on market conditions and fund availability [4].

Group 1 - The company, Baili Tianheng (688506.SH), has received a loan commitment letter from the Bank of China Sichuan Branch [1] - The loan commitment amount is up to 180 million RMB [1] - The loan term is set for 3 years, specifically for the purpose of repurchasing the company's shares [1]

证券代码：688506 证券简称：百利天恒 公告编号：2026-002 四川百利天恒药业股份有限公司 关于取得金融机构股票回购专项贷款承诺函的公告 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。 一、股份回购方案基本情况 1、贷款承诺额度：不超过 1.8 亿元人民币。 2、贷款期限：3 年。 3、贷款用途：专项用于回购公司股份。 本次股票回购具体贷款相关事项以双方正式签订的股票回购贷款合同为准。 三、其他说明 本次收到贷款承诺函可为公司本次回购股份提供融资支持，具体贷款事宜以双 方最终签订的贷款合同为准。本次取得金融机构股票回购贷款承诺函不代表公司对 回购金额的承诺，具体回购股份的数量以实际回购的股份数量为准。 公司将根据后续市场情况及资金到位情况，在回购期限内实施本次股份回购方 案，并按照相关法律法规的规定及时履行信息披露义务。敬请广大投资者注意投资 四川百利天恒药业股份有限公司（以下简称"公司"）于 2025 年 12 月 30 日召 开了第五届董事会第五次会议，审议通过了《关于以集中竞价交易方式回购公司股 份方案的议 ...

Core Viewpoint - The drug ADCiza-bren (BL-B01D1), developed by Sichuan BaiLi Tianheng Pharmaceutical Co., Ltd., has been included in the priority review process by the Center for Drug Evaluation (CDE) for a new indication in treating recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1]. Group 1 - ADCiza-bren is the first ADC drug to achieve positive results in both progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal cancer [1]. - The drug has previously been included in the priority review process for its first indication, advanced nasopharyngeal carcinoma, which was accepted by CDE on November 21 of the same year [1]. - As of now, ADCiza-bren has received seven breakthrough therapy designations from CDE and one from the U.S. Food and Drug Administration (FDA) [2].

Core Viewpoint - Bailitianheng (688506.SH) announced that its self-developed, first-in-class, new concept, and the only EGFR×HER3 dual-target 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 first EGFR×HER3 dual-target ADC globally to be included in the priority review list [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has prioritized the review of Iza-bren (BL-B01D1, an EGFR/HER3 dual antibody ADC) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma in patients who have failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] Group 1 - Iza-bren is the second indication to be prioritized for review, with the first being nasopharyngeal carcinoma, which was prioritized in September 2025 [1] - The new drug application for the nasopharyngeal carcinoma indication was accepted by the NMPA in November 2025 [1] - In the same month, the Phase III study (BL-B01D1-305) for the treatment of esophageal squamous cell carcinoma achieved significant improvements in both progression-free survival (PFS) and overall survival (OS) in its pre-specified interim analysis [1]

Core Viewpoint - The article highlights that BaiLi TianHeng's dual antibody ADC, iza-bren (BL-B01D1), has been included in priority review by the CDE for the treatment of recurrent or metastatic esophageal squamous cell carcinoma in patients who have failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] Group 1 - Iza-bren is the second indication to be included in priority review, following its first indication for nasopharyngeal carcinoma, which was prioritized in September 2025 [1] - The new drug application for the nasopharyngeal carcinoma indication was officially accepted by the CDE in November 2025 [1]

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]

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 ...

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]