抗体偶联药物

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百普赛斯(301080) - 301080百普赛斯投资者关系管理信息20250825
2025-08-25 09:44
证券代码:301080 证券简称:百普赛斯 北京百普赛斯生物科技股份有限公司 投资者关系活动记录表 编号:2025-004 投资者关系活 动类别 √特定对象调研 □分析师会议 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 □其他 参与单位名称 及人员姓名 中欧基金、汇添富基金、招商基金、华泰柏瑞基金、永赢基金、嘉实基金、 富国基金、国盛证券、海通证券、德邦证券、招商证券等 67 家机构 72 名参 与人员 时间 2025 年 8 月 22 日 地点 上海 上市公司接待 人员 董事长、总经理 陈宜顶 副总经理、董事会秘书、财务负责人 林涛 投资者关系活 动主要内容介 绍 问:公司 2025 年半年度业绩? 公司聚焦抗体药与细胞免疫治疗,集中优势资源推动核心业务发展,并 坚定不移地推进全球化战略。公司秉持"市场导向、客户至上、创新驱动"的 研发理念,持续加强重点与热点产品的研发力度,推出一系列高质量且契合 市场需求的产品,有效满足市场对重组蛋白等生物试剂不断增长需求。在内 部管理方面,公司进行全面优化,建立健全营销网络体系,全方位提升综合 竞争力与盈利能力。 2025 年上半年,公司实现营业收入 ...
复宏汉霖(02696):注射用HLX43(靶向PD-L1抗体偶联药物)用于治疗晚期非小细胞肺癌的国际多中心2期临床研究完成美国首例患者给药
智通财经网· 2025-08-22 09:05
本研究为一项评估HLX43在晚期非小细胞肺癌(NSCLC)患者的开放、国际多中心2期临床试验,旨在评 估HLX43在晚期非小细胞肺癌(NSCLC)患者中的有效性和安全性。研究分为两个阶段:第一阶段将进行 剂量探索,以选择合适的HLX43剂量进行第二阶段研究;第二阶段为单臂、多中心2期临床研究。本研究 的主要研究目的为评估HLX43在晚期非小细胞肺癌(NSCLC)中的临床疗效;主要研究终点为由盲态独立 中心审查委员会根据RECISTv1.1标准评估的客观缓解率。 智通财经APP讯,复宏汉霖(02696)发布公告,近日,一项注射用HLX43(靶向PD-L1抗体偶联药物) (HLX43)在晚期非小细胞肺癌(NSCLC)患者中开展的国际多中心2期临床研究已完成美国首例患者给 药。该2期临床研究亦正同步于中国境内(不包括港澳台地区,下同)开展,公司拟于条件具备后于澳大 利亚及日本等国家开展临床试验。 HLX43为靶向PD-L1的抗体偶联药物。截至本公告日,于全球範围内尚无靶向PD-L1的抗体偶联药物获 批上市。 ...
复宏汉霖(02696) - 自愿公告 - 注射用HLX43(靶向PD-L1抗体偶联药物)用於治疗晚期...
2025-08-22 09:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2696) 自願公告 本公告由上海復宏漢霖生物技術股份有限公司(「本公司」)自願作出,以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會(「董事會」)欣然宣佈,近日,一項注射用HLX43(靶向PD-L1 抗體偶聯藥物)(「HLX43」)在晚期非小細胞肺癌(NSCLC)患者中開展的國際 多中心2期臨床研究已完成美國首例患者給藥。該2期臨床研究亦正同步於中 國境內(不包括港澳台地區,下同)開展,本公司擬於條件具備後於澳大利亞 及日本等國家開展臨床試驗。 B. 臨床試驗設計及目的 本研究為一項評估HLX43在晚期非小細胞肺癌(NSCLC)患者的開放、國際 多中心2期臨床試驗,旨在評估HLX43在晚期非小細胞肺癌(NSCLC)患者中 的有效性和安全性 ...
上海复星医药(集团)股份有限公司关于控股子公司获美国FDA药品临床试验批准的公告
Shang Hai Zheng Quan Bao· 2025-08-07 19:06
Group 1 - The core point of the announcement is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd.'s subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct Phase I clinical trials for the new drug HLX43, which is a targeted PD-L1 antibody-drug conjugate for the treatment of thymic carcinoma [2][3] - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [3] - As of June 2025, the cumulative R&D investment for this new drug by the group is approximately RMB 182 million (unaudited) [3] Group 2 - There are currently no approved PD-L1 targeted antibody-drug conjugates available in the global market [4]
复星医药控股子公司获美国FDA药品临床试验批准
Zhi Tong Cai Jing· 2025-08-07 10:21
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate [1] - Fuhong Hanlin plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] Group 2: Drug Development - HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain with a self-developed PD-L1 targeting antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1]
复星医药(600196.SH)控股子公司获美国FDA药品临床试验批准
智通财经网· 2025-08-07 10:21
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1 - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - The company plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] - HLX43 is intended for the treatment of advanced/metastatic solid tumors [1]
复宏汉霖(02696.HK):注射用HLX43(靶向PD-L1抗体偶联药物)获美国食品药品管理局(FDA)批准开展用于治疗胸腺癌(TC)的1期临床试验
Ge Long Hui· 2025-08-07 10:09
Core Viewpoint - The company, Fuhong Hanlin (02696.HK), has received FDA approval to initiate a Phase 1 clinical trial for HLX43, a targeted PD-L1 antibody-drug conjugate, for the treatment of thymic carcinoma (TC) [1] Group 1 - HLX43 is a novel targeted PD-L1 antibody-drug conjugate developed by the company, combining a licensed DNA topoisomerase I inhibitor small molecule toxin with a self-developed PD-L1 targeting antibody [1] - The company plans to conduct clinical trials for the TC indication in countries such as Australia, Japan, and the United States once conditions are met [1] - As of the announcement date, there are no approved PD-L1 targeted antibody-drug conjugates available globally [1]
乐普生物-B(02157)MRG004A(TF ADC)获CDE批准启动胰腺癌三期临床
智通财经网· 2025-08-05 01:14
Core Viewpoint - The initiation of Phase III clinical trials for MRG004A, a targeted antibody-drug conjugate developed by Lepu Biopharma, represents a significant advancement in the treatment of pancreatic cancer, offering new hope for patients suffering from this highly lethal disease [1][4]. Group 1: Drug Development and Mechanism - MRG004A is an innovative antibody-drug conjugate (ADC) targeting tissue factor (TF), utilizing advanced coupling and spacing technologies to link a TF-targeting monoclonal antibody with a potent microtubule inhibitor, MMAE [2][3]. - The mechanism of MRG004A involves the antibody recognizing and binding to TF antigens overexpressed on cancer cells, leading to internalization and release of the cytotoxic agent MMAE, which induces cancer cell death [3]. Group 2: Clinical Trial Data - In the Phase I/II clinical studies presented at the 2024 ASCO annual meeting, MRG004A demonstrated significant anti-tumor activity in pancreatic cancer patients, with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 83.3% in a cohort of 12 evaluable patients [3]. - Among patients with a TF expression rate of ≥50% and intensity of 3+, 80% achieved partial response (PR) or stable disease (SD) after treatment with MRG004A [3]. Group 3: Regulatory Approvals and Market Potential - MRG004A has received several regulatory designations, including orphan drug status from the FDA in December 2023 and fast track designation in March 2024 for the treatment of pancreatic cancer [4]. - Given the high mortality rate associated with pancreatic cancer, with a 5-year overall survival (OS) rate of approximately 10% for advanced cases, the successful completion of the Phase III trial could significantly alter the treatment landscape for this challenging disease [4].
迈威生物注射用7MW4911临床试验申请获受理
Zhi Tong Cai Jing· 2025-07-31 08:05
Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development pipeline [1] Group 1 - The injectable 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17) developed based on the company's proprietary IDDC antibody conjugation technology platform [1] - The acceptance of the clinical trial application by NMPA marks a significant milestone for the company in advancing its drug candidate [1] - The receipt of the IND Acknowledgement Letter from the FDA confirms that the company has submitted its IND application for 7MW4911, facilitating its entry into the U.S. market [1]
康宁杰瑞制药-B:JSKN003获美国FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床研究
Zhi Tong Cai Jing· 2025-07-31 04:37
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1] Group 1: Clinical Study Details - JSKN003-202 is a randomized, open-label, multicenter Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1] - The study will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1] Group 2: Product Characteristics - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycoengineering technology, offering better serum stability compared to traditional coupling methods [2] - The bispecific HER2 targeting allows JSKN003 to induce stronger internalization and bystander killing effects, providing significant anti-tumor activity in HER2-expressing tumors [2] Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop and commercialize JSKN003 in mainland China for tumor-related indications [2] - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2]