BIOKIN PHARMACEUTICAL(688506)
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新股消息 | 百利天恒(688506.SH)通过港交所聆讯 旗下Iza-bren是全球首创的双特异性抗体ADC
智通财经网· 2025-10-21 23:04
Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (688506.SH) is undergoing a listing hearing on the Hong Kong Stock Exchange, with Goldman Sachs, JPMorgan, and CITIC Securities as joint sponsors [1] Company Overview - Baili Tianheng focuses on cutting-edge global biopharmaceuticals, addressing unmet clinical needs, particularly in the field of tumor macromolecule therapy (ADC/GNC/ARC), and aims to establish comprehensive global commercialization capabilities by 2029 [3][4] - The company integrates North America's 0-1 ecosystem advantages and China's 1-N ecosystem advantages to build unique core competencies, aspiring to become a multinational pharmaceutical company (MNC) with a sustained global leading position in oncology [3] Business Development - The company was founded in Seattle in 2014 and has developed the world's first and only EGFR×HER3 bispecific ADC, iza-bren (BL-B01D1), which is currently in Phase III clinical trials [4] - A significant collaboration with BMS was established, involving a total deal value of $8.4 billion, with an upfront payment of $800 million, marking the largest single asset transaction in the global ADC field [4][7] Clinical Research and Pipeline - Baili Tianheng has developed a robust pipeline with nine ADC candidates that have entered clinical stages, conducting approximately 70 clinical studies, including 16 key registration trials in China and three global key registration trials [4] - The company has also developed a multi-specific T cell connector platform and an innovative ARC drug development platform, with several candidates entering clinical stages [4] Financial Performance - The company's revenue for the six months ending June 30 for the years 2022, 2023, 2024, and 2025 was approximately RMB 701.83 million, RMB 560.42 million, RMB 5.82 billion, and RMB 170.41 million, respectively [7][8] - The net profit/loss for the same periods was approximately -RMB 282.38 million, -RMB 780.50 million, RMB 3.71 billion, and -RMB 1.12 billion, indicating significant fluctuations in profitability [7][8]
百利天恒:注射用BL-M24D1(ADC)治疗复发或难治性血液系统恶性肿瘤和晚期实体瘤获药物临床试验批准
Di Yi Cai Jing· 2025-10-21 15:30
Core Viewpoint - The company has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative biopharmaceutical, BL-M24D1, which is an antibody-drug conjugate (ADC) targeting relapsed or refractory hematologic malignancies and advanced solid tumors [1] Group 1 - The clinical trial approval is for the company's self-developed ADC drug, BL-M24D1, which incorporates a new generation toxin [1] - BL-M24D1 is developed from the same small molecule technology platform as BL-B16D1 and BL-M17D1, sharing the same "linker + toxin" platform [1] - The indications for BL-M24D1 include relapsed or refractory hematologic malignancies and advanced solid tumors [1]
百利天恒(688506) - 四川百利天恒药业股份有限公司关于刊发H股聆讯后资料集的公告
2025-10-21 15:15
证券代码:688506 证券简称:百利天恒 公告编号:2025-077 四川百利天恒药业股份有限公司 关于刊发 H 股发行聆讯后资料集的公告 英文: 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")正在进行发行 H 股 股票并在香港联合交易所有限公司(以下简称"香港联交所")主板挂牌上市(以 下简称"本次发行上市")的相关工作。 2024 年 7 月 10 日,公司向香港联交所递交了本次发行上市的申请,并于同 日在香港联交所网站刊登了本次发行上市的申请资料。按照本次发行上市的时间 安排并根据香港联交所的相关规定,公司分别于 2025 年 1 月 21 日、2025 年 9 月 29 日向香港联交所分别重新递交了本次发行的申请,并于同日在香港联交所 网站刊登了本次发行的申请资料。具体内容详见公司分别于 2024 年 7 月 11 日、 2025年1月22日、2025年9月30日在上海证券交易所官方网站(www.sse.com.cn) 披露的《四川百利天恒药业股份有限公司关于向香 ...
百利天恒(688506) - 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M24D1(ADC)治疗复发或难治性血液系统恶性肿瘤和晚期实体瘤获得药物临床试验批准通知书的公告
2025-10-21 15:15
证券代码:688506 证券简称:百利天恒 公告编号:2025-078 四川百利天恒药业股份有限公司 自愿披露关于注射用 BL-M24D1(ADC)治疗复发或难治性 血液系统恶性肿瘤和晚期实体瘤获得药物 临床试验批准通知书的公告 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")近日收到国家药品监督 管理局(NMPA)正式批准签发的《药物临床试验批准通知书》,公司自主研发的创新 生物药注射用 BL-M24D1(ADC)的药物临床试验获得批准。现将相关情况公告如 下: 一、《药物临床试验批准通知书》基本情况 产品名称:注射用 BL-M24D1 受理号:CXSL2500680 BL-M24D1 是公司自主研发的偶联了新一代毒素的 ADC 药物,是与 BL-B16D1 和 BL-M17D1 出自同一小分子技术平台、与 BL-B16D1 和 BL-M17D1 共享同一"连 接子+毒素"平台的 ADC 药物,其适应症为复发或难治性血液系统恶性肿瘤和晚期 实体瘤。 三、风险提示 根据我国药 ...
百利天恒(688506.SH):注射用BL-M24D1(ADC)药物临床试验获批准
智通财经网· 2025-10-21 14:58
Core Viewpoint - The company, Baillie Tianheng, has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative biopharmaceutical, BL-M24D1, which is an antibody-drug conjugate (ADC) targeting relapsed or refractory hematologic malignancies and advanced solid tumors [1] Group 1 - The clinical trial approval is for the company's self-developed ADC drug, BL-M24D1, which is linked to a new generation toxin [1] - BL-M24D1 shares the same "linker + toxin" platform with other ADC drugs, BL-B16D1 and BL-M17D1, developed from the same small molecule technology platform [1] - The indications for BL-M24D1 include treatment for relapsed or refractory hematologic malignancies and advanced solid tumors [1]
百利天恒:注射用BL-M24D1(ADC)药物临床试验获批准
智通财经网· 2025-10-21 14:57
Core Viewpoint - The company, Baile Tianheng (688506.SH), has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative biopharmaceutical, BL-M24D1 (ADC) [1] Group 1: Product Development - BL-M24D1 is an ADC drug that incorporates a new generation toxin, developed independently by the company [1] - The drug is part of the same small molecule technology platform as BL-B16D1 and BL-M17D1, sharing the same "linker + toxin" platform [1] - The indications for BL-M24D1 include relapsed or refractory hematologic malignancies and advanced solid tumors [1]
百利天恒:注射用BL-M24D1(ADC)获药物临床试验批准通知书
Xin Lang Cai Jing· 2025-10-21 14:51
百利天恒公告,近日收到国家药品监督管理局(NMPA)正式批准签发的《药物临床试验批准通知书》, 公司自主研发的创新生物药注射用BL-M24D1(ADC)的药物临床试验获得批准。BL-M24D1是公司自 主研发的偶联了新一代毒素的ADC药物,适应症为复发或难治性血液系统恶性肿瘤和晚期实体瘤。 ...
据港交所文件:四川百利天恒药业股份有限公司通过港交所上市聆讯。
Xin Lang Cai Jing· 2025-10-21 14:33
据港交所文件:四川百利天恒药业股份有限公司通过港交所上市聆讯。 ...
BD密集落地,持续关注创新药械产业链
Haitong Securities International· 2025-10-21 12:34
Investment Rating - The report maintains a positive outlook on the innovative drug and medical device industry, highlighting key targets for investment [5][24]. Core Insights - The innovative drug sector is experiencing high growth, with a focus on companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. The report emphasizes the potential for value re-evaluation in these firms [5][24]. - Recent business development (BD) deals in the innovative drug sector are expected to catalyze market activity, with notable transactions including Jiangsu Heng Rui Medicine's agreement with Kite for a $1.20 billion upfront payment, potentially reaching $15.20 billion in total [5][24]. - The A-share pharmaceutical sector underperformed the broader market in the third week of October 2025, with the Shanghai Composite Index falling by 1.5% and the SW Biopharma index declining by 2.5% [7][18]. Summary by Sections 1. Continuous Focus on Innovative Drugs and Medical Devices - The report emphasizes the high growth potential in innovative drugs, with key investment targets including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. Related targets include CSPC Innovation Pharmaceutical [5][24]. 2. A-Share Pharmaceutical Sector Performance - In the third week of October 2025, the A-share pharmaceutical sector saw a decline of 2.5%, underperforming the Shanghai Composite Index, which fell by 1.5%. The report notes that the sector's premium relative to all A-shares is currently at a normal level, with a relative premium rate of 74.5% [7][14][21]. 3. Hong Kong and U.S. Pharmaceutical Sector Performance - The report indicates that the Hong Kong and U.S. pharmaceutical sectors also underperformed, with the Hang Seng Healthcare index dropping by 5.8% and the S&P 500 Healthcare index increasing by only 0.7% during the same period [18][24].