注射用HLX43

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港股异动 | 复宏汉霖(02696)盘中涨超8% HLX43完成美国首例患者给药 旗下三款核心产品将亮相WCLC
智通财经网· 2025-08-29 07:48
消息面上,复宏汉霖公告,近日完成了注射用HLX43(靶向PD-L1抗体偶联药物)在晚期非小细胞肺癌 (NSCLC)患者中的国际多中心2期临床研究的美国首例患者给药。招银国际发表研究报告指,随著复 宏汉霖的生物仿制药在中国和全球持续产生现金流入,集团正发展成为以HLX43为主导的创新生物制 剂公司。 值得注意的是,2025年世界肺癌大会(WCLC)官网近日公布入选摘要,复宏汉霖共有10项肺癌研究成功 入选。本次入选研究围绕三款核心创新药展开:抗PD-1单抗H药汉斯状(斯鲁利单抗)、抗EGFR单抗 HLX07,以及全球首个进入II期临床的PD-L1 ADC HLX43。花旗表示,复宏汉霖即将在WCLC公布 HLX43的最新数据,将进一步揭示其在非小细胞肺癌(NSCLC)治疗的潜力。若HLX43能在更多样本中维 持35%至40%的客观缓解率(ORR)及约5.5个月的无恶化生存期(mPFS),有关数据将会极具说服力。 智通财经APP获悉,复宏汉霖(02696)盘中涨超8%,截至发稿,涨5.34%,报77.95港元,成交额9026.11 万港元。 ...
科兴制药筹划发行H股;复宏汉霖:完成HLX43晚期肺癌临床研究美国首例患者给药丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-08-24 23:21
丨 2025年8月25日 星期一 丨 NO.1 科兴制药筹划发行H股 科兴制药公告,公司正在筹划发行H股并在香港联交所上市,并与相关中介机构就本次H股上市的具体 推进工作进行商讨,相关细节尚未确定。本次H股上市能否通过审议、备案和审核程序并最终实施具有 不确定性。2025年上半年,科兴制药营业收入为7亿元,同比下降近8%,归母净利润为8034万元,同比 上升576%。 点评:科兴制药筹划H股上市,若推进顺利可拓宽融资渠道、助力国际化布局,但需经多轮审议与审 批,后续进展及市场环境将影响最终落地,长期需关注其资本运作对业务的支撑效果。 NO.2 复宏汉霖:完成HLX43晚期肺癌临床研究美国首例患者给药 复宏汉霖公告,近日完成了注射用HLX43(靶向PD-L1抗体偶联药物)在晚期非小细胞肺癌(NSCLC) 患者中的国际多中心2期临床研究的美国首例患者给药。该临床研究同时在中国进行,并计划在条件具 备后扩展至澳大利亚和日本等国家。 点评:复宏汉霖HLX43完成美国首例患者给药,作为PD-L1 ADC布局晚期肺癌,推进国际多中心临 床,有利于拓展全球市场,后续临床数据将成其商业化关键。 NO.3 圣诺生物:股东拟合计 ...
港股公告掘金 | 东风集团股份拟被溢价私有化 岚图汽车申请介绍上市
Zhi Tong Cai Jing· 2025-08-24 12:38
先健科技(01302):镍钛合金动脉导管未闭封堵器进入创新医疗器械特别审查程序 重大事项: 舜宇光学科技(02382)与歌尔股份(002241.SZ)及歌尔光学订立谅解备忘录,促进上海奥来与歌尔光学的 优势互补 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 上海医药(02607):缩宫素注射液及醋酸奥曲肽注射液获得菲律宾药品注册证书 石药集团(01093):SYS 6036注射液在中国获临床试验批准 佳兆业集团(01638)与中信城开就深圳福田佳园项目达成战略合作 康耐特光学(02276)纳入恒生综合指数成份股 中国中铁(00390):尖扎黄河特大桥事故原因正在调查之中 已致12人遇难4人失联 东风集团股份(00489)拟被溢价私有化 岚图汽车申请介绍上市 佰泽医疗(02609)获纳入恒生指数系列成份股 经营业绩: 国泰航空(00293)7月国泰航空与香港快运合共接载旅客约320万人次 创下今年的单月新高 石药集团(01093)发布中期业绩 股东应占溢利25.48亿元 同比减少15.64% TCL电子(01070) ...
复宏汉霖(02696.HK):HLX43用于治疗晚期非小细胞肺癌(NSCLC)的国际多中心2期临床研究完成美国首例患者给药
Ge Long Hui· 2025-08-22 09:12
格隆汇8月22日丨复宏汉霖(02696.HK)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。 ...
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
Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced the completion of the first patient dosing in the United States for an international multicenter phase 2 clinical trial of HLX43, a PD-L1 targeted antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Trial Details - The phase 2 clinical trial is designed to evaluate the efficacy and safety of HLX43 in patients with advanced NSCLC [1] - The study consists of two phases: the first phase focuses on dose exploration to select an appropriate dose for the second phase, while the second phase is a single-arm, multicenter phase 2 clinical study [1] - The primary objective of the study is to assess the clinical efficacy of HLX43 in advanced NSCLC, with the main endpoint being the objective response rate evaluated by a blinded independent review committee according to RECIST v1.1 criteria [1] Group 2: Market Context - As of the date of the announcement, there are no approved PD-L1 targeted antibody-drug conjugates available in the global market [1] - The company plans to conduct clinical trials in Australia and Japan once conditions are suitable, in addition to the ongoing trials in China (excluding Hong Kong, Macau, and Taiwan) [1]
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 ...
启迪药业控制权将变更;硕世生物上半年净利润同比降逾八成丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-08-10 23:21
Group 1 - Tsinghua Unigroup's control will change as Hunan Sailuxian will acquire approximately 58.61 million shares from its controlling shareholder, Tsinghua Technology Service Co., Ltd, leading to a shift in control of Tsinghua Unigroup [1] - The new controlling shareholder will need to stabilize the company's operations amidst industry consolidation, and investors should pay attention to future asset integration and the new shareholder's resource injection capabilities, with potential short-term stock price volatility [1] Group 2 - Shuoshi Bio reported a revenue of 176 million yuan, a year-on-year decrease of 1.05%, and a net profit attributable to shareholders of 3.99 million yuan, down 86.35% year-on-year, primarily due to the deepening of centralized procurement in the in vitro diagnostic industry and an increase in the VAT rate to 13% [2] - The decline in net profit is attributed to pressure on product prices from industry procurement, a significant drop in gross margin, and a 13.11% reduction in R&D investment, which may weaken long-term competitiveness [2] Group 3 - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic cancer, marking a significant step in the internationalization of innovative drugs [3] - The drug's dual advantages of immune modulation and precise targeting position it competitively in the global market, with the potential to fill a treatment gap for thymic cancer if subsequent data is positive [3] Group 4 - Junshi Biosciences announced that the National Medical Products Administration has accepted the application for the 13th indication of its PD-1 monoclonal antibody, Toripalimab, for use in combination with HER2 ADC for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [4] - This combination is expected to further strengthen Junshi's differentiated positioning in the PD-1 market and enhance collaboration with Rongchang Bio on ADC development [4]
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]
复星医药股价小幅下跌 子公司获FDA批准开展新药临床试验
Jin Rong Jie· 2025-08-07 18:41
Core Viewpoint - Fosun Pharma's stock price is currently at 26.37 yuan, reflecting a decline of 0.98% from the previous trading day, with a trading volume of 724 million yuan [1] Company Overview - Fosun Pharma is a large pharmaceutical enterprise focused on drug manufacturing and research, covering the entire pharmaceutical health industry chain [1] - The company's main products include anti-tumor drugs, cardiovascular system drugs, and central nervous system drugs [1] Recent Developments - Fosun Pharma's subsidiary, Fosun Hani, has recently received FDA approval to conduct Phase I clinical trials for HLX43, an injectable drug for the treatment of thymic cancer [1] - HLX43 is a PD-L1 targeted antibody-drug conjugate intended for the treatment of advanced/metastatic solid tumors [1] - The company plans to conduct global multi-center clinical research for this indication in Australia, Japan, and the United States [1] - As of June 2025, the cumulative R&D investment for this new drug is expected to be approximately 182 million yuan [1]
复星医药(600196)控股子公司获美国FDA药品临床试验批准
Sou Hu Cai Jing· 2025-08-07 17:54
Group 1 - The company announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval to conduct Phase I clinical trials for HLX43, a PD-L1 targeted antibody-drug conjugate for thymic carcinoma treatment [1] - The company plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] Group 2 - The pharmaceutical business is the core of the company, focusing on three main areas: innovative drugs, mature products and manufacturing, and vaccines [2] - The innovative drug segment emphasizes oncology and immune-inflammatory treatments, enhancing core technology platforms like antibody/ADC and cell therapy [2] - The mature products and manufacturing segment aims for integrated development, focusing on high-margin products and increasing the proportion of complex generics and modified new drugs [2] - The vaccine business has established a self-developed system centered on bacterial and viral vaccine technology platforms, aiming to accelerate the launch of self-developed vaccine products [2] Group 3 - The company maintains healthy and high-quality development, ranking 4th in the "2023 China Pharmaceutical Industry Top 100 Enterprises" list [3] - It ranked 4th in the comprehensive R&D strength ranking and 3rd in the chemical drug R&D strength ranking in the "2024 China Drug R&D Strength Ranking" [3] - The company was included in the "Global TOP25 Pharmaceutical Companies by Pipeline Size" for the third consecutive year [3] - In 2024, the company's hospital prescription drug sales revenue ranked 12th nationwide according to IQVIA [3] - The company maintained an A rating in the MSCI ESG rating for 2024 and was recognized in various ESG-related rankings [3] Group 4 - For the fiscal year 2024, the company achieved a revenue of 41.067 billion yuan and a net profit of 2.77 billion yuan [4]