Core Viewpoint - The company, BaiLi TianHeng, announced that its self-developed EGFR×HER3 dual antibody ADC (iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) of China, marking it as the first of its kind to enter Phase III clinical trials and receive priority review status [1] Group 1 - The drug, iza-bren, is the first EGFR×HER3 dual antibody ADC globally to be included in the priority review list [1] - Iza-bren has been recognized as a breakthrough therapy for recurrent or metastatic nasopharyngeal carcinoma that has failed at least two lines of chemotherapy and prior PD-1/PD-L1 monoclonal antibody treatment [1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met its primary endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1]

Core Viewpoint - The company announced that its self-developed, first-in-class EGFR×HER3 dual antibody ADC (Iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) in China, marking a significant milestone in its clinical development [1] Group 1 - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1] - The drug is currently undergoing over 40 clinical trials in China and the United States for various types of tumors [1]

证券代码：688506 证券简称：百利天恒 公告编号：2025-056 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 局部晚期或转移性鼻咽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。根据公开资料查询，iza-bren 也是全球首个 被纳入优先审评品种名单的 EGFR×HER3 双抗 ADC，现将相关情况公告如下： 一、药品的基本情况 药品名称：注射用 BL-B01D1/iza-bren 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 单抗治疗且经至 少两线化疗（至少 ...

Core Viewpoint - The company, Baillie Gifford, has announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC, Iza-bren, has been included in the priority review list by the National Medical Products Administration (NMPA) of China, marking it as the first EGFR×HER3 dual antibody ADC to receive such recognition globally [1][1][1] Group 1 - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials, and it is currently undergoing over 40 clinical trials for various types of tumors in both China and the United States [1][1][1] - The NMPA has included Iza-bren in the list of breakthrough therapy products for the treatment of recurrent or metastatic nasopharyngeal carcinoma, which has previously failed at least two lines of chemotherapy [1][1][1] - The interim analysis of the Phase III clinical trial for the treatment of recurrent or metastatic nasopharyngeal carcinoma has met the primary research endpoint, and the company has completed pre-New Drug Application (Pre-NDA) communication with the NMPA regarding this indication [1][1][1]

跟股价一样，百利天恒的核心产品iza-bren(BL-B01D1)不断给外界释放更多想象空间。 随着2025年WCLC(世界肺癌大会)进入倒计时，包括"iza-bren联合奥希替尼"在内的几项ADC(抗体偶联 药物)研究数据摘要却集体"缺席"。 近期，百利天恒(688506.SH，股价392.5元，市值1573.93亿元)创下股价新高。 这家"由仿转创"的创新药企业，在与百时美施贵宝(BMS)达成授权合作后，一跃成为国产创新药企 业"新贵"。眼下，在最初的喧嚣过后，市场更关注百利天恒的核心产品iza-bren何时能迎来首个适应证 获批上市、在肺癌等大癌种方面iza-bren将取得哪些突破，以及公司的现金流能否覆盖多箭齐发的研发 管线。 对于这些问题，在公司业绩说明会上，百利天恒董事长朱义一一作了回答。他坦言："要成为一家入门 级的MNC(跨国药企)，公司还需要时间和资金支持。"iza-bren两项临床数据或被纳入WCLC官方新闻发 布计划 另一方面，iza-bren拓展临床的策略以及多个临床试验进入关键阶段，意味着将消耗百利天恒更多的研 发费用。 上文提及的iza-bren在中国和美国进行的40余项临床试验中 ...

Core Insights - Bailitianheng (688506.SH) has reached a new stock price high of 392.5 yuan, with a market capitalization of 157.39 billion yuan, following its partnership with Bristol-Myers Squibb (BMS) for the innovative drug Iza-bren [1] - The market is now focused on the approval timeline for Iza-bren's first indication and its potential breakthroughs in treating major cancers like lung cancer [1] - The company aims to become a leading entry-level multinational corporation (MNC) in the oncology field, requiring time and financial support [1] Product Development - Iza-bren (BL-B01D1) is expected to have two clinical data presentations at the 2025 World Conference on Lung Cancer (WCLC), including studies on its use as a monotherapy and in combination with Osimertinib for treating EGFR-mutant non-small cell lung cancer [2] - Iza-bren is the only EGFR×HER3 dual antibody ADC developed by Bailitianheng that has entered Phase III clinical trials [2] - The drug is currently involved in over 40 clinical trials in China and the U.S., with five indications included in the breakthrough therapy list by the National Medical Products Administration [3] Clinical Strategy - The company has initiated three new Phase II/III overseas key registration clinical trials this year, targeting triple-negative breast cancer, EGFR-mutant non-small cell lung cancer, and urothelial carcinoma [3] - Iza-bren's first potential indication for approval is for the treatment of end-stage nasopharyngeal carcinoma, with plans to submit a New Drug Application (NDA) if the interim analysis meets primary endpoints [4] Financial Overview - Bailitianheng's R&D expenses have significantly increased, with a 90.74% year-on-year rise to 1.039 billion yuan in the first half of the year, leading to a higher proportion of R&D spending relative to revenue [6] - The company anticipates a funding gap of approximately 4.819 billion yuan over the next three years, with plans to raise up to 3.764 billion yuan through a private placement [7] - The total investment in Iza-bren and other projects is projected to reach 4.353 billion yuan by the end of 2024 [6]

Group 1 - The average stock price of the Sci-Tech Innovation Board is 37.44 yuan, with 57 stocks priced over 100 yuan, and the highest priced stock is Cambrian-U at 1202.00 yuan, which fell by 14.45% today [1] - Among the stocks priced over 100 yuan, 80 stocks increased in price while 504 stocks decreased, with an average decline of 5.35% for the hundred-yuan stocks today [1] - The average premium of the hundred-yuan stocks relative to their issue price is 373.57%, with Cambrian-U, Baile Tianheng, and Anji Technology having the highest premiums of 1766.75%, 1489.07%, and 1211.41% respectively [1] Group 2 - The net outflow of main funds from the hundred-yuan stocks today totaled 4.734 billion yuan, with Cambrian-U, Naxinwei, and Haooubo seeing the highest net inflows of 141.35 million yuan, 60.21 million yuan, and 50.51 million yuan respectively [2] - The total margin balance for hundred-yuan stocks is 69.882 billion yuan, with the highest margin balances held by SMIC, Cambrian-U, and Haiguang Information at 11.623 billion yuan, 11.311 billion yuan, and 7.619 billion yuan respectively [2]

Market Overview - The Shanghai Composite Index fell by 1.97% to 3738.32 points, while the Shenzhen Component Index decreased by 2.37% to 12176.9 points, and the ChiNext Index dropped by 3.2% to 2806.63 points [2][3] - Over 2600 stocks in the market experienced declines, indicating a broad market downturn [2] Sector Performance - The tourism and hotel sector showed resilience with a gain of 3.21%, while the battery sector increased by 2.27% [4] - Conversely, the semiconductor sector faced significant losses, contributing to the overall market decline [2][7] Trading Volume - The total trading volume of the Shanghai and Shenzhen markets exceeded 1 trillion yuan, marking an increase of over 160 billion yuan compared to the previous day [8] Gold and Silver Prices - Spot gold prices fell below $3520 per ounce, reflecting a daily decrease of 1.27% [5] - Spot silver also saw a decline of 1%, trading at $40.78 per ounce [9] Futures Market - The FTSE China A50 Index futures dropped by over 2% during the trading session [6] Notable Stocks - Significant movements were observed in stocks such as Zhengye Technology, which hit a 20% limit up, and Shengli Precision, which rose by 10.09% [15][16]

Market Overview - The A-share market experienced a significant decline, with major indices continuing to drop on September 4th [2] - The Shanghai Composite Index closed at 3734.20, down 79.36 points or 2.08% [3] - The Shenzhen Component Index fell by 493.1 points, a decrease of 3.95%, closing at 11978.81 [3] - The ChiNext Index saw a decline of 5.36%, closing at 2744.03 [3] Sector Performance - The STAR 50 Index (科创50) dropped over 7%, with major constituent stocks like Cambrian (寒武纪) falling more than 15% [3][6] - The overall trading volume in the A-share market was reported at 418.2 billion [3] Key Stock Movements - Cambrian (688256) saw a significant drop of 15.37%, closing at 1189.02 [6] - Other notable declines included Baillie Gifford (688506) down 7.22% and Huatai Medical (688617) down 4.31% [6] - The STAR 50 Index's performance reflects broader market trends, with a year-to-date decline of 14.54% [4]

Core Insights - The ChiNext 50 Index has experienced a decline of over 5% [1] - Among the constituent stocks, Cambricon has dropped over 10%, Haiguang Information has decreased by over 8%, and Baili Tianheng has fallen by over 7% [1] - Only 7 stocks within the index have shown an increase [1]