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复宏汉霖(02696.HK):修订就汉斯状®与ABBOTT及KGBIO的许可协议
Ge Long Hui· 2026-02-24 09:01
公司董事会宣布,于2026年2月24日,经双方友好磋商,公司与KGBio订立修订及部分终止协议 ("KGBio许可协议修订及部分终止协议"),以终止原KGBio许可协议项下于除印度尼西亚以外的其他地 区("KGBio终止区域")许可产品的独家许可权利。 同日,公司与Abbott订立许可协议修订本("Abbott许可协议修订本"),就原Abbott许可协议项下有关许可 产品的许可区域及里程碑付款等事项的若干条款作出修订,以进一步扩大原Abbott许可协议项下许可产 品的许可区域(包括KGBio终止区域及其他约定的国家或地区)。 格隆汇2月24日丨复宏汉霖(02696.HK)公布,有关公司与KGBio就汉斯状®(斯鲁利单抗注射液)("许可产 品')于约定的东南亚、中东及北非地区国家的独家开发及商业化许可权利达成若干协议("原KGBio许可 协议")。 2024年12月,公司与Abbott就(其中包括)许可产品于约定的拉丁美洲及加勒比海地区国家的独家商业化 许可权利达成协议("原Abbott许可协议")。 经双方友好磋商,公司与KGBio终止就许可产品于KGBio终止区域的相关商业化合作,并将许可产品于 新增许可区 ...
复宏汉霖(02696) - 自愿公告 - 注射用HLX43(靶向PD-L1抗体偶联药物)联合HLX0...
2026-02-11 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 注射用HLX43(靶向PD-L1抗體偶聯藥物) 聯合HLX07(重組抗EGFR人源化單克隆抗體注射液) 或漢斯狀® (斯魯利單抗注射液) 在晚期或轉移性結直腸癌患者中開展的1b/2期臨床研究 於中國境內完成首例患者給藥 A. 緒言 1 料,暫定HLX43的劑量水準為2.5 mg/kg和3.0 mg/kg,該階段主要目的是研究不 同劑量HLX43聯合固定劑量HLX07在轉移性結直腸癌(mCRC)患者中的有效性, 次要目的包括評價其安全性和耐受性、HLX43的PK特徵和免疫原性、並研究潛在 預測性或耐藥性生物標誌物。第二部分為一項隨機、多中心、開放標籤研究,評 估HLX43 2.0 mg/kg或2.5 mg/kg聯合固定劑量漢斯狀®(30 ...
复宏汉霖:与Eisai公司签订许可协议 将获得首付款7500万美元
Jin Rong Jie· 2026-02-05 09:00
本文源自:金融界AI电报 复宏汉霖(02696.HK)公告,公司与日本制药公司EisaiCo.,Ltd.订立许可协议,公司将授予Eisai独家许 可,供其于区域及领域内商业化许可产品汉斯状®(斯鲁利单抗注射液)。Eisai将向本公司支付首付款 7500万美元,监管里程碑款项合计至多8001万美元,基于许可产品于区域内的各项监管里程碑达成情况 支付;商业销售里程碑款项合计至多2.3333亿美元,基于许可产品于区域内的年度净销售额水平达成情 况支付以及以许可产品于区域内的年度净销售额的两位数百分比计的特许权使用费。 ...
复宏汉霖(02696)就汉斯状® 治疗肿瘤适应症与Eisai 订立许可协议
智通财经网· 2026-02-05 08:50
据悉,汉斯状® (斯鲁利单抗注射液)为公司自主开发的创新型抗PD-1单抗,其于中国境内(不包括中国 港澳台地区,下同)已获批上市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期 小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC)。同时,汉斯状® 亦已分别于欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西亚、新加坡、及印度等国家/地区获批上 市,并分别获美国、欧盟、瑞士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定。此外, 公司正有序推进汉斯状® 及相关联合疗法在全球开展的多项临床试验,广泛覆盖肺癌、食管癌、头颈 鳞癌、结直肠癌和胃癌等适应症。2025年12月,汉斯状®联合化疗于胃癌新辅助/辅助治疗的药品注册 申请获国家药品监督管理局(NMPA)受理,并已纳入优先审评审批程序。 本次与Eisai就许可产品于区域内的商业化合作将有助于进一步拓展公司产品的海外市场,增强公司产品 在国际市场的可及性和认可度,从而为公司收入的持续提升创造条件。 智通财经APP讯,复宏汉霖(02696)公布,公司于2026年2月5日与Eisai Co., Ltd ...
复宏汉霖(02696.HK):就汉斯状®与Eisai订立的许可协议 首付款7500万美元
Ge Long Hui· 2026-02-05 08:50
格隆汇2月5日丨复宏汉霖(02696.HK)宣布,公司于2026年2月5日与Eisai Co., Ltd.("Eisai")订立一份许可 协议,据此,公司同意向Eisai授出一项许可,供其于日本("区域")及领域(定义如下文)内开发、生产和 商业化汉斯状®(斯鲁利单抗注射液)("许可产品")。 本次与Eisai就许可产品于区域内的商业化合作将有助于进一步拓展公司产品的海外市场,增强公司产品 在国际市场的可及性和认可度,从而为公司收入的持续提升创造条件。 汉斯状®在中国境内的销售推广由公司自建商业化团队主导。截至公告日期,公司已分别与多个国际知 名合作伙伴就汉斯状®于全球超100个国家和地区的商业化达成合作。 根据许可协议,公司将授予Eisai:(a) 一项独家许可,供其于区域及领域内商业化许可产品;及(b) 仅就 上文(a)项所述目的,于区域及领域内开发和生产许可产品的共同排他许可(即公司亦有权开发和生产)。 Eisai将向公司支付:(a) 首付款7500万美元,于许可协议订立后支付;(b) 监管里程碑款项合计至多8001 万美元,基于许可产品于区域内的各项监管里程碑达成情况支付;(c) 商业销售里程碑款项合 ...
复宏汉霖(02696):注射用HLX43联合HLX07及汉斯状® 用于晚期实体瘤治疗的临床试验申请获国家药品监督管理局批准
智通财经网· 2026-01-27 09:37
Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for clinical trial applications of HLX43 in combination with HLX07 and Hanshuo® for the treatment of advanced solid tumors [1][2] Group 1: Clinical Trial Approvals - The clinical trial application for HLX43, a PD-L1 targeted antibody-drug conjugate, in combination with HLX07 and Hanshuo® has been approved by NMPA [1] - The company plans to conduct the relevant clinical trials within China once conditions are met [1] Group 2: Clinical Data and Product Development - Phase 1 clinical data for HLX43 will be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and the 2025 World Lung Cancer Conference (WCLC), showing promising safety and preliminary efficacy in non-small cell lung cancer (NSCLC) and other solid tumors [2] - HLX07, an innovative biopharmaceutical targeting EGFR, has shown good safety and tolerability in a 1b/2 phase clinical study for advanced solid tumors conducted in February 2023 [2] - Hanshuo®, an innovative anti-PD-1 monoclonal antibody developed by the company, has been approved for multiple indications in mainland China, including first-line treatment for squamous NSCLC and extensive-stage small cell lung cancer [2] - The New Drug Application (NDA) for Hanshuo® in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer has been accepted by NMPA and is under priority review [2]
复宏汉霖(02696.HK):汉斯状®(斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的上市注册申请(NDA)获国家药品监督管理局(NMPA)受理,并已纳入优先审评
Ge Long Hui· 2025-12-12 08:53
Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its self-developed drug Hanshuan® (sulizumab injection) for a new indication in the treatment of PD-L1 positive, resectable gastric cancer patients, which is now prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The NDA acceptance is based on a Phase 3 clinical study that demonstrated the efficacy and safety of Hanshuan® combined with chemotherapy compared to placebo combined with chemotherapy, significantly extending the event-free survival (EFS) of patients [1] - The study met the predefined superiority criteria and showed better safety and tolerability compared to standard chemotherapy [1] Group 2 - Hanshuan® is an innovative anti-PD-1 monoclonal antibody that has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received orphan drug designation in several regions, including the US, EU, Switzerland, and South Korea, and is approved in multiple countries such as the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - The company is actively advancing multiple clinical trials for Hanshuan® and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]
复宏汉霖(02696.HK):汉斯状联合化疗用于胃癌新辅助/辅助治疗获国家药监局正式纳入突破性治疗药物程序
Ge Long Hui A P P· 2025-11-20 09:01
Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' drug Hansizhuang® has received recognition from the NMPA, indicating a significant step in its development for gastric cancer treatment [1] - The inclusion in the breakthrough therapy designation process suggests potential expedited review and approval, which could enhance the drug's market entry timeline [1]
复宏汉霖(02696.HK):汉斯状®联合化疗用于胃癌新辅助/辅助治疗获国家药监局正式纳入突破性治疗药物程序
Ge Long Hui· 2025-11-20 08:53
Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' Hansizhuang® has received recognition from NMPA's Center for Drug Evaluation (CDE) [1]
《财富》专访复星医药董事长陈玉卿:出发与归来
财富FORTUNE· 2025-09-22 13:09
Core Viewpoint - The article emphasizes the journey and vision of Fosun Pharma under the leadership of Chairman Chen Yuqing, focusing on innovation, global expansion, and the integration of AI in drug development and operations [3][10][20]. Group 1: Company Background and Leadership - Chen Yuqing transitioned from academia to the corporate world 26 years ago, eventually becoming the Chairman of Fosun Pharma in April 2025 [1][3]. - Under his leadership, Fosun Pharma has grown into a nearly 100 billion yuan global innovative pharmaceutical company, with a strong emphasis on corporate culture that fosters innovation and talent development [3][4]. Group 2: Innovation and Product Development - Fosun Pharma has consistently prioritized innovation, launching 12 innovative drugs since 2019, including the first CAR-T product in China and the first PD-1 monoclonal antibody approved for small cell lung cancer [4][6]. - The company’s innovative drug revenue exceeded 4.3 billion yuan in the first half of 2025, accounting for 31% of its pharmaceutical business revenue, with a year-on-year growth of 14.26% [8][10]. Group 3: Globalization Strategy - Fosun Pharma's globalization strategy focuses on building local capabilities rather than merely exporting products, with over 1,000 personnel in its overseas commercialization team and a marketing network covering over 110 countries [10][12]. - The company has established regional distribution centers in emerging markets and has supplied over 420 million doses of anti-malarial products globally, significantly impacting public health [13][20]. Group 4: AI Integration in Operations - Fosun Pharma is actively integrating AI into its operations, utilizing the PharmAID decision-making platform to enhance drug development efficiency, reducing target validation time by over 60% [14][15]. - The company emphasizes that while AI is a powerful tool for enhancing efficiency, it cannot replace the intrinsic value of human expertise and understanding of patient needs [16][17]. Group 5: Future Vision and Commitment - The company aims to become a global "Big Pharma" over the next decade, focusing on innovation, deep internationalization, and comprehensive AI adoption as its core strategies [19][20]. - Fosun Pharma's mission remains to ensure every family enjoys health, reflecting its commitment to addressing clinical needs through continuous innovation [20].