Core Viewpoint - The company, Bai Li Tian Heng, has announced that its self-developed drug, iza-bren (EGFR×HER3 dual antibody ADC), has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer patients [2] Group 1 - The drug iza-bren is described as a first-in-class and new concept therapy, indicating its innovative nature in the oncology field [2] - The drug has reached the III phase of clinical trials, showcasing its advanced development stage [2] - The inclusion in the breakthrough therapy list signifies a potential acceleration in the drug's approval process and market entry [2]

Core Viewpoint - The National Medical Products Administration (NMPA) has included the first-in-class EGFR x HER3 dual antibody ADC, izabren (BL-B01D1), developed by Bai Li Tian Heng, in the list of breakthrough therapies for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer patients [1] Group 1 - The drug izabren is recognized as a new concept and is the only one currently in Phase III clinical trials [1] - A total of six indications for izabren have been included in the breakthrough therapy list by the drug review center [1]

中信证券股份有限公司 关于四川百利天恒药业股份有限公司 2025 年半年度持续督导跟踪报告 中信证券股份有限公司（以下简称"中信证券"或"保荐人"）作为四川百 利天恒药业股份有限公司（以下简称"百利天恒"或"公司"或"上市公司"） 首次公开发行股票并在科创板上市持续督导阶段的保荐人，于 2025 年 3 月 27 日与公司签订保荐协议，自保荐协议生效之日起，承接原保荐人国投证券股份有 限公司尚未完成的持续督导工作。根据《证券发行上市保荐业务管理办法》《上 海证券交易所科创板股票上市规则》等相关规定，中信证券履行持续督导职责， 并出具本持续督导半年度跟踪报告。 一、持续督导工作概述 1、保荐人制定了持续督导工作制度，制定了相应的工作计划，明确了现场 检查的工作要求。 2、保荐人已与公司签订《四川百利天恒药业股份有限公司与中信证券股份 有限公司关于向特定对象发行人民币普通股（A 股）并上市之保荐协议》，该协 议已明确了双方在持续督导期间的权利义务，并报上海证券交易所备案。 3、本持续督导期间（2025 年 1 月 1 日至 2025 年 6 月 30 日），保荐人通过 与公司的日常沟通、现场回访等方式开展持续督导 ...

Market Overview - The main funds in the Shanghai and Shenzhen markets experienced a net outflow of 5.62 billion yuan, with the Sci-Tech Innovation Board seeing a net outflow of 1.51 billion yuan [1] - A total of 242 stocks saw net inflows, while 346 stocks experienced net outflows [1] Sci-Tech Innovation Board Performance - On the Sci-Tech Innovation Board, 251 stocks rose, with one stock, Jia Yuan Technology, hitting the daily limit, while 332 stocks declined [1] - The top three stocks with the highest net inflows were: - Haiguang Information: 708.48 million yuan - Lanke Technology: 388.18 million yuan - Jia Yuan Technology: 195.88 million yuan [1] Continuous Fund Flow - There were 46 stocks with continuous net inflows for more than three trading days, with Hanwujing leading at 16 consecutive days of inflow [1] - Conversely, 114 stocks had continuous net outflows, with the most significant outflow from SMIC at 318 million yuan, despite its price increasing by 0.89% [1] Key Stocks with Net Inflows - The following stocks had notable net inflows: - Haiguang Information: 708.48 million yuan, with a price increase of 5.46% [1] - Lanke Technology: 388.18 million yuan, with a price increase of 5.70% [1] - Jia Yuan Technology: 195.88 million yuan, with a price increase of 20.00% [1] Key Stocks with Net Outflows - The stocks with the highest net outflows included: - SMIC: 318 million yuan, with a price increase of 0.89% [1] - Baiji Shenzhou: 224 million yuan [1] - Baili Tianheng: 150 million yuan [1] Fund Flow Analysis - The analysis indicates a mixed sentiment in the market, with significant inflows into certain stocks while others faced substantial outflows, reflecting investor behavior and market dynamics [1][2]

Core Viewpoint - The company, Baili Tianheng (688506.SH), has announced that its self-developed drug, iza-bren (EGFR × HER3 dual antibody ADC), has been included in the breakthrough therapy list by the National Medical Products Administration's Drug Review Center, marking a significant milestone as it is the first-in-class and the only drug to reach Phase III clinical trials for patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1] Summary by Categories - **Product Development** - Iza-bren is a first-in-class and new concept drug that targets EGFR and HER3 [1] - The drug has reached Phase III clinical trials, indicating advanced development status [1] - **Regulatory Milestone** - The drug has been included in the breakthrough therapy list by the National Medical Products Administration [1] - This inclusion signifies recognition of the drug's potential to address unmet medical needs in specific cancer types [1] - **Target Patient Population** - The drug is aimed at patients suffering from platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1]

证券代码：688506 证券简称：百利天恒 公告编号：2025-058 四川百利天恒药业股份有限公司 自愿披露关于注射用 iza-bren（EGFR×HER3 双抗 ADC） 用于铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者 纳入突破性治疗品种名单的公告 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。 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 iza-bren（EGFR ×HER3 双抗 ADC）用于铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者 已被国家药品监督管理局药品审评中心（以下简称"药审中心"）纳入突破性治疗 品种名单，近日已完成公示，现将主要情况公告如下： | 药品名称 | 注射用 BL-B01D1/iza-bren | | | | --- | --- | --- | --- | | 受理号 | CXSL2101249 | | | | 药品类型 | 治疗用生物制品 | | | ...

Group 1 - The average stock price of the Sci-Tech Innovation Board is 38.24 yuan, with 60 stocks priced over 100 yuan, and the highest priced stock is Cambrian-U at 1273.00 yuan, which increased by 3.66% [1][2] - Among the stocks priced over 100 yuan, 33 stocks increased in price today, with notable gainers including DingTong Technology, JiePuTe, and XinQi Micro [1][2] - The average premium of the stocks priced over 100 yuan relative to their issue price is 379.18%, with Cambrian-U, BaiLi TianHeng, and AnJi Technology showing the highest premiums of 1877.02%, 1288.70%, and 1238.73% respectively [1][2] Group 2 - The sectors with the highest concentration of stocks priced over 100 yuan on the Sci-Tech Innovation Board include electronics (26 stocks), pharmaceuticals (12 stocks), and computers (9 stocks) [2] - The net inflow of main funds into stocks priced over 100 yuan today totaled 765 million yuan, with the highest net inflows seen in HaiGuang Information, LanQi Technology, and Cambrian-U [2] - The total margin balance for stocks priced over 100 yuan is 72.93 billion yuan, with the highest balances in ZhongXin International, Cambrian-U, and HaiGuang Information [2][3]

Core Insights - BaiLi TianHeng's drug, iza-bren (EGFR×HER3 bispecific ADC), has been recognized at the 2025 World Lung Cancer Conference (WCLC) for its significant clinical value in treating EGFR-mutant lung cancer [1] - The drug has shown promising results in two studies, indicating its potential to change clinical practice [1] Group 1: Study Results - The first study involved 154 patients treated with iza-bren (2.5 mg/kg D1D8Q3W) combined with Osimertinib, achieving a 100% objective response rate (ORR) and a 92.1% progression-free survival (PFS) rate at 12 months [2] - The second study reported a median PFS exceeding 12 months for patients with advanced or metastatic solid tumors treated with iza-bren, with a 94% tumor shrinkage rate and an ORR of 66% [3] Group 2: Clinical Development - Iza-bren is the first and only EGFR×HER3 bispecific ADC currently in Phase III clinical trials globally, with nearly 40 clinical trials ongoing in China and the U.S. for various tumor types [4] - The drug has been prioritized for review by the Center for Drug Evaluation (CDE) for use in recurrent or metastatic nasopharyngeal carcinoma patients [4]

Core Viewpoint - Baili Tianheng's self-developed drug, iza-bren, has shown promising results in treating EGFR-mutant lung cancer, as presented at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Research Results - The Phase II study of iza-bren combined with Osimertinib for first-line treatment of EGFR-mutant NSCLC reported an objective response rate (ORR) of 100% among 40 patients receiving a 2.5 mg/kg dose [1] - The 12-month progression-free survival (PFS) rate was 92.1%, and the overall survival (OS) rate reached 94.8% [1] - All patients exhibited a reduction in target lesions, indicating effective treatment [1]

Group 1 - The core viewpoint of the news is the performance and financial status of Sichuan Baili Tianheng Pharmaceutical Co., Ltd., which saw a stock price increase of 5.02% to 403.26 CNY per share, with a total market capitalization of 161.707 billion CNY [1] - The company was established on August 17, 2006, and went public on January 6, 2023, focusing on the research, production, and sales of pharmaceuticals [1] - The main business revenue composition indicates that 99.57% is recognized at a specific point in time, while 0.43% is recognized over a specific period [1] Group 2 - From the perspective of fund holdings, the Oriental Alpha Fund has a significant position in Baili Tianheng, with the Oriental Alpha Healthcare Mixed Fund A (014841) reducing its holdings by 32,900 shares, now holding 26,400 shares, which represents 4.92% of the fund's net value [2] - The fund has achieved a year-to-date return of 61.16%, ranking 334 out of 8,179 in its category, and a one-year return of 68.02%, ranking 1,385 out of 7,984 [2] - The fund manager, Meng Yu, has been in position for 1 year and 286 days, with the fund's total assets amounting to 169 million CNY, achieving a best return of 40.45% and a worst return of 15.84% during his tenure [3]