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]

Core Viewpoint - The company Baile Tianheng, led by its founder Zhu Yi, reported a significant decline in its half-year performance, with revenue dropping by 96.92% to 171 million yuan and a net loss of 1.118 billion yuan, marking a shift from profit to loss. Despite this, the company's market capitalization has surged, reaching approximately 153.98 billion yuan, doubling within the year, which has elevated Zhu Yi to the title of the richest person on the Sci-Tech Innovation Board [2][3][24]. Financial Performance - In the first half of the year, Baile Tianheng's revenue was only 171 million yuan, a decrease of 96.92% year-on-year, representing the worst performance since 2015 [9]. - The company's net profit attributable to shareholders plummeted by 123.96%, resulting in a loss of 1.118 billion yuan, a stark contrast to previous profits [9]. - The company's total liabilities reached 4.386 billion yuan, with an asset-liability ratio of 61.05% [12]. Investment and R&D - Baile Tianheng has been heavily investing in research and development, with R&D expenses rising from 181 million yuan in 2019 to 1.443 billion yuan in 2024. In the first half of 2025 alone, R&D expenses reached 1.039 billion yuan, a year-on-year increase of 90.74% [10][11]. - The company has 15 innovative drugs in clinical trials and has invested a total of 3.396 billion yuan in these projects, with expected total investment reaching 4.353 billion yuan [11]. Strategic Partnerships - A significant turning point occurred at the end of 2023 when Baile Tianheng's subsidiary SystImmune entered a global strategic cooperation agreement with Bristol-Myers Squibb (BMS) for the development and commercialization of BL-B01D1, which includes an upfront payment of 800 million USD and a potential total transaction value of up to 8.4 billion USD [6][22]. - This partnership is expected to dramatically boost Baile Tianheng's revenue and net profit in 2024, with projected revenue growth of 936.31% to 5.823 billion yuan and net profit soaring by 575.02% to 3.708 billion yuan [7]. Market Position and Future Outlook - Despite the recent financial struggles, Baile Tianheng's market capitalization has increased significantly, reflecting investor confidence in its innovative drug pipeline and future growth potential [24]. - The company aims to establish itself as a leading multinational pharmaceutical company, focusing on innovative drug development in the oncology sector [10].

北京商报讯(记者丁宁)据百利天恒(688506)9月7日消息，公司自主研发的iza-bren(EGFR×HER3双抗 ADC)治疗EGFR突变肺癌的两项研究，双双入选2025WCLC官方新闻发布计划。 iza-bren(BL-B01D1)单药治疗局晚期或转移性EGFR突变NSCLC患者的I/II期研究的研究结果显示，50例 患者既往接受过EGFR-TKI但未接受过化疗。Iza-bren单药治疗mPFS12.5个月，疗效优势覆盖所有EGFR 突变亚组。ORR66%，DCR90%，mDoR13.7个月，靶病灶缩瘤率94%。中位随访20.5个月，mOS尚未达 到，18个月OS率为69.2%。 其中，iza-bren(BL-B01D1)联合奥希替尼治疗局晚期或转移性EGFR突变非小细胞肺癌患者的II期研究的 研究结果显示，40例患者接受iza-bren2.5mg/kg D1D8Q3W联合奥希替尼一线治疗，ORR100%，靶病灶 缩瘤率100%，12个月PFS率92.1%，12个月OS率94.8%。 ...