Core Viewpoint - The company, Bai Li Tian Heng, has announced the completion of the first patient enrollment in a Phase III clinical trial for its first-in-class, new concept EGFR×HER3 dual antibody ADC (iza-bren) targeting platinum-resistant recurrent epithelial ovarian cancer [1] Group 1 - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials globally [1] - The clinical trial for iza-bren is part of over 40 ongoing clinical studies in China and the United States for various tumor types [1] - In addition to the current trial, iza-bren is also involved in nine other Phase III registration clinical trials in China for non-small cell lung cancer, small cell lung cancer, breast cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and urothelial carcinoma [1]

Core Insights - SystImmune, Inc., a wholly-owned subsidiary of Baillie Gifford (688506.SH), has received Breakthrough Therapy Designation from the FDA for izalontamabbrengitecan (iza-bren) for treating locally advanced or metastatic non-small cell lung cancer with specific mutations after prior treatments [1][2] Group 1 - The Breakthrough Therapy Designation is based on clinical research data from studies BL-B01D1-101, BL-B01D1-203, and BL-B01D1-LUNG-101, demonstrating the reliability of existing data [2] - The designation highlights the significant unmet clinical needs faced by patients after EGFR TKI and platinum-based chemotherapy, as most patients experience disease progression approximately 18 months after first-line treatment [2] - The FDA's Breakthrough Therapy Designation aims to expedite the development and review process for drugs that may significantly outperform existing standard therapies [2]

Core Insights - SystImmune, Inc., a wholly-owned subsidiary of Baillie Gifford, has received Breakthrough Therapy Designation from the FDA for izalontamabbrengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer with specific mutations after prior treatments [1][2] Group 1 - The Breakthrough Therapy Designation is based on clinical research data from studies BL-B01D1-101, BL-B01D1-203, and BL-B01D1-LUNG-101, demonstrating the reliability of existing data [2] - The designation highlights the significant unmet clinical needs faced by patients after treatment with EGFR TKI and platinum-based chemotherapy, as most patients experience disease progression approximately 18 months after first-line treatment [2] - The FDA's Breakthrough Therapy Designation aims to expedite the development and review process for drugs that may significantly outperform existing standard therapies [2]

证券代码：688506 证券简称：百利天恒 公告编号：2025-052 化疗后进展的 EGFR 突变 NSCLC 患者中展现出令人鼓舞的疗效和可控的安全性。 二、风险提示 根据美国药品注册相关的法律法规要求，药物在获得临床试验许可后，尚需 开展临床试验，并经 FDA 批准后方可上市。 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） 用于治疗晚期 EGFR 突变的非小细胞肺癌获得 美国 FDA 突破性疗法认定的公告 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"）全资子公司 SystImmune, Inc.（以下简称"SystImmune"）与合作伙伴百时美施贵宝（以下简 称"BMS"）宣布，美国食品药品监督管理局（以下简称"FDA"）已授予 izalontamab brengitecan（iza-bren）突破性疗法认定（Breakthrough Therapy Designation），用 于既往 EGFR-TKI 及 ...

Iza-bren 是全球首创（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。近日，iza-bren 用于铂耐药复发上皮性卵 巢癌的临床研究已进入 III 期临床试验阶段并完成首例受试者入组。 截至目前，iza-bren 正在中国和美国进行 40 余项针对多种肿瘤类型的临床试 验，除本次新入组的临床试验外，iza-bren 在非小细胞肺癌、小细胞肺癌、乳腺癌、 鼻咽癌、食管鳞癌、尿路上皮癌等 9 项国内 III 期注册临床试验也处于受试者入组 的阶段。 证券代码：688506 证券简称：百利天恒 公告编号：2025-051 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） 用于铂耐药复发上皮性卵巢癌 III 期临床试验 完成首例受试者入组的公告 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）、 ...

Core Viewpoint - The company, Baili Tianheng, has announced the completion of the first patient enrollment in a Phase III clinical trial for its first-in-class EGFR×HER3 dual-targeted antibody-drug conjugate (ADC), iza-bren, aimed at platinum-resistant recurrent epithelial ovarian cancer patients [1] Group 1 - The Phase III clinical trial for iza-bren is the only one of its kind that has entered this stage globally [1] - Currently, iza-bren is involved in over 40 clinical trials targeting various tumor types in both China and the United States [1] - In addition to the newly enrolled trial, iza-bren is also in the patient enrollment phase for nine domestic Phase III registration clinical trials, including those for non-small cell lung cancer, small cell lung cancer, breast cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and urothelial carcinoma [1]

Core Viewpoint - The announcement highlights that SystImmune, a wholly-owned subsidiary of the company, has received Breakthrough Therapy Designation from the FDA for izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer with specific mutations after prior treatment failures [1] Group 1 - The Breakthrough Therapy Designation was granted based on multiple clinical trial data conducted in China and the United States [1]

Group 1 - The A-share market experienced a strong upward trend on August 18, with the Shanghai Composite Index reaching a nearly 10-year high [1] - The STAR Market Composite Index ETF by Huatai-PB rose by 1.94%, indicating positive market sentiment [1] - The STAR Market Composite Index itself surged by 2.08%, with notable gains from constituent stocks such as Nanxin Pharmaceutical and Shunlian Bio, both increasing by over 20% [1] Group 2 - As of August 18, 2025, the top ten constituent stocks of the STAR Market ETF include companies like Saiwei Technology and Haiguang Information, with varying performance in terms of price changes and trading volumes [2] - The semiconductor industry in China saw a total investment of 455 billion yuan in the first half of 2025, reflecting a 9.8% year-on-year decline, while semiconductor equipment investment grew by 53.4%, highlighting a strategic focus on supply chain autonomy [3] - Major global tech companies are significantly increasing their capital expenditures for AI infrastructure, with Microsoft planning to spend $88.2 billion in the 2025 fiscal year, followed by Google and Meta with substantial increases as well [3][4]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

Core Insights - The core viewpoint of the news is the performance and holdings of the E Fund Healthcare Industry Mixed A Fund, highlighting its recent returns and key stock positions [1]. Fund Performance - The latest net value of E Fund Healthcare Industry Mixed A is 4.7830 yuan [1]. - The fund has achieved a weekly return of 3.57% [1]. - Over the past three months, the fund's return is 44.07% [1]. - Year-to-date, the fund has generated a return of 57.03% [1]. Fund Details - E Fund Healthcare Industry Mixed A was established on January 28, 2011 [1]. - As of June 30, 2025, the fund's total assets amount to 3.944 billion yuan [1]. - The fund is managed by Yang Zhenshao [1]. Top Holdings - The top ten stock holdings of the fund include: - Heng Rui Medicine - Hotgen Biotech - Xinlitai - BeiGene-U - Haizhi Science - Nocren Health-U - Yipinhong - Kelun Pharmaceutical - Shutaishen - Baili Tianheng [1]. - The combined proportion of the top ten holdings is 58.14% [1].