撰文丨王聪 编辑丨王多鱼 排版丨水成文 2025 年 10 月 19 日，国际顶尖医学期刊 《 柳叶刀 》发表了一项 中国原创抗癌新药 的 3 期 临床试验结 果。 这项由中山大学肿瘤防治中心牵头、全国 55 家医院共同完成的 3 期临床试验显示，新型 双特异性抗体偶 联药物 （bispecific ADC）—— 伦康依隆妥单抗 （izalontamab brengitecan，iza-bren） 在经多线治疗 失败的 晚期鼻咽癌 患者中，疗效显著优于标准化疗。 中山大学肿瘤防治中心 张力 教授为论文通讯作者，中山大学肿瘤防治中心 杨云鹏 主任医师、 周华强 副 主任医师、 唐林泉 主任医师、福建省肿瘤医院 邱素芳 教授、湖南省肿瘤医院 韩亚骞 教授为论文共同第 一作者。 治疗困境：晚期鼻咽癌亟需新方案 鼻咽癌 是一种具有明显地域特征的恶性肿瘤，中国尤其是华南地区高发。2022 年全球数据显示，每年新 增病例约 12 万例，死亡约 7.3 万例。 对于经过多线治疗失败的晚期鼻咽癌患者，现有治疗方案效果有限，预后极差，急需新的治疗选择。 作用机制：双特异性 ADC 的精准杀伤原理 伦康依隆妥单抗 （izalon ...

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Core Insights - BaiLi TianHeng, an innovative pharmaceutical company, is accelerating its dual capital platform strategy by submitting a prospectus to the Hong Kong Stock Exchange after completing the largest A-share equity financing in the healthcare sector since the implementation of the comprehensive registration system [1][3] - The company's stock price has seen a significant increase, reaching a peak of 414.02 CNY per share by September 8, 2025, representing a cumulative increase of over 15 times since its initial public offering [1][2] - BaiLi TianHeng's recent A-share private placement raised a total of 3.764 billion CNY, with participation from top fund managers, marking a key step in its global expansion strategy [3][4] Financing and Market Position - The A-share private placement in September 2025 was the largest equity financing in the healthcare sector since the registration system was implemented, with 30 investors participating and 18 successfully winning bids [3][4] - The funds raised will be used entirely for innovative drug research and development, particularly for advancing the HIRE-ADC platform and GNC platform [3][4] - BaiLi TianHeng has become a star stock among institutional investors, with significant investments from prominent fund managers [3][4] Clinical Development and Breakthroughs - BaiLi TianHeng's core pipeline, including the drug BL-B01D1, has shown promising results in clinical trials, particularly in treating EGFR mutation non-small cell lung cancer [6][7] - The company reported a 100% objective response rate in a phase II study for the combination treatment of BL-B01D1 and Osimertinib, indicating a significant breakthrough in treatment options [6][7] - The drug has received breakthrough therapy designation from regulatory authorities, which will expedite its development and review process [7][8] Leadership and Vision - The company's rise is closely linked to the personal journey of its founder, Zhu Yi, who transitioned from academia to entrepreneurship and aims to establish BaiLi TianHeng as an entry-level multinational corporation (MNC) within five years [10][11][13] - Zhu Yi's vision includes developing blockbuster drugs and collaborating with MNCs, positioning BaiLi TianHeng as a key player in the global pharmaceutical landscape [10][13]

Core Viewpoint - The company Baillie Gifford has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical T-Bren (HER2ADC), which is being compared to pembrolizumab combined with platinum-based chemotherapy for first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical study comparing T-Bren to pembrolizumab combined with platinum-based chemotherapy has recently entered its third phase and completed the first patient enrollment [1] Group 2 - Currently, T-Bren is involved in 14 clinical trials domestically and internationally, including 5 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, post-operative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-mutated non-squamous non-small cell lung cancer, as well as other cancers such as lung, gastrointestinal, urological, and gynecological tumors [1]

Core Viewpoint - The company Baillie Gifford has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical T-Bren (HER2ADC), which is being compared to pembrolizumab combined with platinum-based chemotherapy for first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical study comparing T-Bren to pembrolizumab combined with platinum-based chemotherapy has recently entered the trial phase and completed the first patient enrollment [1] Group 2 - Currently, T-Bren is involved in 14 clinical trials both domestically and internationally, including 5 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, post-operative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-mutated non-squamous non-small cell lung cancer, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

证券代码：688506 证券简称：百利天恒 公告编号：2025-076 T-Bren（BL-M07D1）是一种靶向 HER2 的创新型 ADC，具有同类最佳 （Best-in-class）潜力，已在临床试验中展示出显著的抗肿瘤功效。近日，T-Bren 对比帕博利珠单抗联合含铂化疗用于在一线 HER2 突变的晚期或转移性非鳞状非 小细胞肺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。 自愿披露关于 T-Bren（HER2 ADC）用于在一线 HER2 突变 的晚期或转移性非鳞状非小细胞肺癌 III 期临床试验 截至目前，T-Bren 正在国内外开展 14 项临床试验，包括 5 个 III 期、1 个 II/III 期、2 个 II 期、3 个 I/II 期及 3 个 I 期临床试验，覆盖一线和二线及以上 HER2 阳 性乳腺癌、HER2 阳性乳腺癌术后辅助、HER2 阳性乳腺癌新辅助治疗、HER2 低 表达乳腺癌、HER2 阳性胃或胃食管结合部腺癌和 HER2 突变的非鳞状非小细胞肺 癌，以及肺癌、消化道肿瘤、泌尿系统肿瘤和妇科肿瘤等多项适应症。 二、风险提示 根据我国药品注册相关的法律法规要 ...

Core Viewpoint - The innovation drug sector in China is experiencing significant growth, driven by increased investment, favorable policies, and a strong pipeline of new drugs entering clinical trials, positioning it for a robust future in both domestic and international markets [6][8][10]. Group 1: Market Performance - As of October 16, the Science and Technology Innovation Drug ETF (Huitianfu, 589120) saw a notable increase of 3.31%, maintaining a rise of over 2% despite a slight pullback [1]. - The ETF has attracted over 40 million yuan in net inflows over the past five days, indicating strong investor interest [1]. - Key constituent stocks such as Sangfor Technology and Yifang Bio have shown significant gains, with Sangfor hitting the daily limit up and Yifang Bio rising by 8.61% [2][3]. Group 2: Industry Trends - The number of License-out transactions in China reached 72 in the first half of 2025, surpassing half of the total for 2024, with a total transaction value 16% higher than the previous year [5]. - The innovation drug sector is primarily driven by business development (BD) expectations, with a significant portion of annual BD activity occurring in the fourth quarter [6]. - The Chinese innovation drug market is expected to see a recovery in confidence as more BD deals materialize, particularly as companies prepare for the upcoming European Society for Medical Oncology (ESMO) conference [6][7]. Group 3: R&D and Financial Outlook - Since 2015, Chinese innovation drug companies have significantly increased R&D investments, leading to a rise in the number of original innovative drugs entering clinical trials, with 704 drugs expected to enter Phase I trials in 2024 [8]. - The revenue of innovation drug companies has been steadily increasing, with projections indicating that one-third of these companies will achieve profitability by 2025, and 70% will reach breakeven by 2026 [8]. - The Chinese government's support for innovation drugs through favorable policies and increased funding is expected to enhance the sector's growth, with healthcare spending on innovation drugs projected to rise from 50 billion yuan in 2022 to 120 billion yuan in 2024 [9]. Group 4: Competitive Landscape - The impending patent cliff for multinational corporations (MNCs) is expected to create a demand for new products, with 190 drugs losing patent protection by 2030, including 69 with annual sales exceeding 1 billion dollars [10]. - Chinese innovation drug companies are well-positioned to fill this gap due to their high R&D efficiency and rich technological outcomes, making them attractive partners for MNCs [10].

Core Viewpoint - The company, BaiLi Tianheng (688506.SH), has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical, T-Bren (HER2 ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after first-line anti-HER2 treatment failure [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical trial for T-Bren has recently entered the first patient enrollment stage, focusing on patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma [1] Group 2 - Currently, T-Bren is involved in 13 clinical trials both domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The clinical trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

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 innovative biopharmaceutical, T-Bren (HER2 ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after failure of first-line anti-HER2 therapy [1] Group 1: Product Development - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The clinical research for T-Bren has entered Phase III and completed the first patient enrollment for the specified indication [1] Group 2: Clinical Trials Overview - Currently, T-Bren is involved in 13 clinical trials domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, and HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

Core Viewpoint - The company, Bai Li Tian Heng, has completed the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical, T-Bren (HER2ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after first-line anti-HER2 treatment failure [1] Group 1: Product Development - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The clinical research for T-Bren has entered Phase III and completed the first patient enrollment for the specified indication [1] Group 2: Clinical Trials - Currently, T-Bren is involved in 13 clinical trials domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]