Core Viewpoint - The biopharmaceutical sector in China is experiencing a positive trend in innovation and investment, with significant growth in the approval of innovative drugs and a recovery in market conditions [1][2] Industry Summary - As of September 8, 2025, the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.89%, with notable gains from companies such as United Imaging Healthcare (688271) up 11.48% and BGI Genomics (688114) up 9.35% [1] - The "National Drug Safety Publicity Week" launched on September 1 highlights the positive development of the pharmaceutical industry, with 210 innovative drugs approved in the past five years, indicating a sustained growth trend [1] - Currently, approximately 30% of the world's innovative drugs under research are from China, showcasing the country's significant role in global pharmaceutical innovation [1] Company Summary - The top ten weighted stocks in the Sci-Tech Innovation Board Biopharmaceutical Index as of August 29, 2025, include United Imaging Healthcare (688271), BeiGene (688235), and others, collectively accounting for 50.27% of the index [2] - The Sci-Tech Biopharmaceutical ETF (588250) closely tracks the performance of the Sci-Tech Innovation Board Biopharmaceutical Index, reflecting the overall performance of representative biopharmaceutical companies listed on the Sci-Tech Board [2]

Company Overview - Baili Tianheng (688506.SH) recently reached a historical high stock price of 410 CNY per share, with a market capitalization exceeding 164.4 billion CNY [2] - As of September 5, 2023, the stock price closed at 388.02 CNY per share, with a market capitalization of over 150 billion CNY [4] Stock Performance - Since its listing on the Sci-Tech Innovation Board in January 2023 at an initial price of 24.7 CNY per share, Baili Tianheng's stock has increased over 14 times [3] - The stock has shown significant growth, with projected price increases of 37.05% and 102.38% for 2024 and 2025, respectively [4] Major Shareholder - The actual controller, Zhu Yi, holds 74.35% of the shares, with the value of his holdings estimated at approximately 115.69 billion CNY [4] - Zhu Yi's wealth is estimated at 95 billion CNY, making him the richest person in Sichuan province [4] Product Development - Baili Tianheng's drug Iza-bren, a first-in-class dual-specific antibody-drug conjugate (ADC), has been accepted for priority review by the National Medical Products Administration for treating advanced or metastatic nasopharyngeal carcinoma [4][5] - The company has 15 innovative drugs in clinical stages and 2 in IND acceptance stages, with 3 drugs in Phase III clinical trials [6] Industry Context - The ADC sector has become a focal point in cancer treatment, with China emerging as a key player in ADC research and development, accounting for approximately 40% of global ADC pipelines [7] - The market for innovative drug concepts has seen significant growth, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index rising over 100% this year [5]

Core Viewpoint - Bailitianheng's stock price has reached a historical high, significantly increasing its market capitalization and the wealth of its controlling shareholder, Zhu Yi [1][3][6]. Company Performance - Bailitianheng's stock price hit a peak of 410 CNY per share, with a market value exceeding 164.4 billion CNY, and closed at 388.02 CNY per share on September 5, 2023, with a market cap over 150 billion CNY [1][3]. - Since its listing on the Sci-Tech Innovation Board in January 2023 at an issue price of 24.7 CNY per share, the stock has surged over 14 times [1]. - The stock is projected to record increases of 37.05% and 102.38% in 2024 and 2025, respectively [3]. Shareholder Wealth - Zhu Yi, the controlling shareholder, holds 74.35% of the company, with his shares valued at approximately 115.69 billion CNY, making him the richest person in Sichuan [3][6]. Product Development - The continuous rise in stock price is attributed to the market's positive outlook on its core product, BL-B01D1 (iza-bren), which is the world's first EGFR×HER3 dual-target ADC currently in Phase III clinical trials [6]. - Bailitianheng has 15 innovative drugs in clinical stages and 2 in IND acceptance stages, with 3 drugs in Phase III registration clinical trials and nearly 90 clinical trials globally [7]. Industry Context - The innovative drug sector has been favored in the market, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index rising over 100% this year, and numerous biopharmaceutical companies in A-shares and Hong Kong experiencing stock price doubling [6].

Core Viewpoint - Baili Tianheng's stock price has reached a historical high, significantly increasing its market capitalization and the wealth of its controlling shareholder, Zhu Yi [1][3]. Company Performance - Baili Tianheng's stock price hit a peak of 410 CNY per share, with a market value exceeding 164.4 billion CNY [1]. - As of September 5, 2023, the stock price closed at 388.02 CNY per share, with a total market capitalization of approximately 155.6 billion CNY [3]. - Since its listing on the STAR Market in January 2023 at an initial price of 24.7 CNY per share, the stock has increased over 14 times [1]. Shareholder Wealth - Zhu Yi, the controlling shareholder, holds 74.35% of the company's shares, with the value of his holdings estimated at around 115.7 billion CNY [3]. - Zhu Yi's wealth is reported to be approximately 95 billion CNY, making him the richest person in Sichuan, surpassing previous wealth holders [7]. Product Development - The continuous rise in Baili Tianheng's stock price is attributed to its core product, BL-B01D1, which is in the III clinical trial phase and has been prioritized by the National Medical Products Administration [7]. - BL-B01D1 is a novel EGFR×HER3 dual-targeted ADC, developed since 2014, aimed at treating various cancers [8]. Strategic Partnerships - In December 2023, Baili Tianheng signed a collaboration agreement with Bristol-Myers Squibb (BMS) for the development and commercialization of BL-B01D1, with a potential total transaction value of up to 8.4 billion USD [8]. - This partnership is expected to generate significant revenue, with projected earnings of 5.823 billion CNY in 2024, reflecting a year-on-year increase of 936.31% [8]. Research and Development - The company has been increasing its R&D expenditures, with R&D costs accounting for 132.81%, 24.78%, and 606.69% of total revenue in 2023, 2024, and the first half of 2025, respectively [9]. - As of mid-2025, Baili Tianheng has 15 innovative drugs in clinical stages and 2 in the IND acceptance stage, with nearly 90 clinical trials ongoing globally [9].

Core Insights - The company, Baile Tianheng, announced that its self-developed drug, iza-bren, has been included in the priority review list by the National Medical Products Administration (NMPA) [1] - Iza-bren is the world's first and only EGFR×HER3 dual-targeted antibody-drug conjugate (ADC) to enter Phase III clinical trials [1] - The intended indication for iza-bren is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including at least one platinum-based regimen, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] Company Summary - Baile Tianheng is recognized for its innovative approach in developing the first-in-class dual-targeted ADC, which highlights its commitment to advancing cancer treatment [1] - The inclusion of iza-bren in the priority review list signifies a potential acceleration in the drug's approval process, which could lead to significant market opportunities [1] Industry Context - The development of dual-targeted therapies like iza-bren reflects a growing trend in the oncology field towards more personalized and effective treatment options for complex cancers [1] - The prioritization by regulatory authorities indicates a positive outlook for novel therapies in addressing unmet medical needs in oncology [1]

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 ...