2025年7月1日—复宏汉霖(2696.HK)宣布与汉康生技(HanchorBio)控股子公司FBD Biologics Limited(简称“FBD”)达成战略合作,复宏汉霖将获得由汉康生技自主开发的SIRPα-Fc融合蛋白HCB101在中国(除台湾地区)、东南亚特定国家及中东和北非地区(MENA)特定国家的开发、生产及商业化独家许可权益,以及在日本市场的优先谈判权。根据协议条款,汉康生技有望获得1000万美元的首付款、共计1.92亿美元的潜在里程碑付款及合作区域销售分成。复宏汉霖执行董事兼首席执行官朱俊博士表示复宏汉霖始终以创新为驱动,深耕肿瘤免疫治疗领域。HCB101是一款新型SIRPα-Fc融合蛋白,其单药使用或联合抗PD-1单抗已经在肿瘤 (包括实体瘤) 治疗中观察到初步积极的肿瘤响应,且药物安全性良好,更有望与复宏汉霖创新管线形成深度协同,进一步强化我们在肿瘤免疫联合疗法上的全球竞争力。期待与汉康生技携手创新,加速为全球肿瘤患者带来更高效、更可及的解决方案。汉康生技董事长兼执行长刘世高博士表示该授权顺利签约,标志着汉康创新药走向全球市场取得又一关键进展,有助于汉康成为一个备受肯定的国际化创新医药公司,更有助于汉康达成造福全球癌症患者的使命。HCB101是一款潜在同类最优(best-in- class)的Fc-融合SIRPα变体,由人信号调节蛋白 α(SIRPα)的工程化 IgV 域与IgG4 Fc 域融合而成。通过封锁CD47-SIRPα免疫检查点,HCB101能够促进巨噬细胞吞噬肿瘤细胞,提高抗原可及性并活化树突细胞。HCB101在优化免疫激活,以及降低血液学毒性方面优势显著。与传统抗CD47单克隆抗体不同,该分子具备高选择性的肿瘤靶向结合能力,同时降低红细胞(RBC)结合,减少贫血和血小板减少等常见副作用,在CD47靶向疗法中具有明显的安全性优势。目前,HCB101已在单药或者联合用药的治疗中皆展现了初步的疗效及良好的安全性, 一项在中国大陆、美国等多地开展的HCB101联合标准疗法治疗晚期实体瘤的Ib/IIa期研究正在进行中。此次引进汉康生技具有自主知识产权的SIRPα-Fc融合蛋白,有望进一步丰富复宏汉霖在肿瘤免疫治疗领域的布局,提升公司在该领域的领先优势。复宏汉霖前瞻性布局多款创新产品,覆盖肿瘤免疫治疗多个关键通路。其中,公司自主研发的抗PD-1单抗 H药 汉斯状®(斯鲁利单抗)为全球首个获批一线治疗小细胞肺癌(SCLC)的抗PD-1单抗,在中国、印度尼西亚、新加坡、德国等近40个国家和地区获批上市。创新型PD-L1 ADC HLX43为全球率先进入II期临床开发的PD-L1靶向ADC, 在临床前和早期临床研究中,尤其是非小细胞肺癌(NSCLC)和胸腺鳞癌(TSCC)领域展现了令人鼓舞的安全性和初步疗效。HCB101能够通过阻断CD47-SIRPα信号通路激活巨噬细胞抗肿瘤活性,与复宏汉霖现有PD-1/L1抑制剂及其他核心管线产品形成深度协同,为新一代肿瘤免疫治疗方案开辟路径。未来,复宏汉霖将持续聚焦未满足的临床需求,立足于公司在抗体领域的累积优势,不断扩充创新潜力靶点,积极探索前沿技术与疗法,加强优质创新资产的合作,为全球患者带来更多高质量、可负担的创新治疗方案。关于汉康科技汉康生技(HanchorBio,7827.TWO)总部设于台北、上海及美国旧金山湾区,是一家专注于肿瘤免疫治疗(Immuno-Oncology)的全球生物技术公司。公司由拥有丰富经验的制药产业专家带领,在生物药发现与全球开发方面具有卓越成功的记录,致力于重塑癌症治疗格局。汉康生技致力于重新启动人体免疫系统,以对抗恶性疾病。公司自主开发的Fc-基因工程多功能生物药平台(FBDB™, Fc-Based Designer Biologics),能够构建具备多重靶点机制的创新生物药,通过先天性免疫与适应性免疫的协同调控,克服当前PD-1/PD-L1免疫疗法的局限性。该技术平台已在多种体内肿瘤动物模型中成功验证概念(Proof-of-Concept, PoC),展现出突破性的免疫调节潜力。通过研发创新多功能分子结构,并持续优化生产制程与CMC(化学、制造与管制)开发,汉康生技致力于开发突破性的创新疗法,为尚未被满足的临床需求提供解决方案。了解更多,请造访官方网站:www.HanchorBio.com关于复宏汉霖复宏汉霖(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已有6款产品在中国获批上市,4款产品在国际获批上市,5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控,不断夯实一体化综合生产平台,其中,公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖约50个分子,并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前,公司已获批上市产品包括国内首个生物类似药汉利康®(利妥昔单抗)、自主研发的中美欧三地获批单抗生物类似药汉曲优®(曲妥珠单抗,美国商品名:HERCESSI™,欧洲商品名:Zercepac®)、汉达远®(阿达木单抗)、汉贝泰®(贝伐珠单抗)、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®(斯鲁利单抗,欧洲商品名:Hetronifly®)以及汉奈佳®(奈拉替尼)。公司亦同步就19个产品在全球范围内开展30多项临床试验,对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius and HanchorBio Collaborate to Develop Novel SIRPα-Fc Fusion Protein, Expanding Tumor Immunotherapy LayoutShanghai, China, July 1, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that it had entered into a strategic cooperation agreement with FBD Biologics Limited ("FBD"), a holding subsidiary of HanchorBio. Henlius is granted exclusive rights to develop, manufacture and commercialize HCB101, a SIRPα-Fc fusion protein independently developed by HanchorBio, in China and certain countries and regions in Southeast Asia as well as Middle East and North Africa (MENA), alongside the right of first negotiation (ROFN) for the molecule in Japanese market. Under the terms of the agreement, HanchorBio is eligible to receive a $10 million upfront payment and up to $192 million in potential predetermined milestones, in addition to royalties upon Henlius commercialization in the territory.Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, "Henlius remains committed to pioneering innovation in tumor immunotherapy. HCB101 is a novel SIRPα-Fc fusion protein that has shown preliminary positive tumor responses and a good safety profile when used as monotherapy or in combination with anti-PD-1 monoclonal antibody in the treatment of tumors (including solid tumors). It’s also expected to form in-depth synergy with Henlius' innovative pipeline, further strengthening our global competitiveness in tumor immunotherapy combination therapy. We look forward to working with HanchorBio to drive innovation and accelerate the delivery of more efficient and accessible solutions for tumor patients worldwide."Dr. Scott Liu, Founder, Chairman, and CEO of HanchorBio, remarked, "The successful signing of the HCB101 licensing agreement marks another milestone in propeling HanchorBio's innovative drugs onto the global stage. This collaboration not only positions HanchorBio as a globally recognized biotechnology company, but more importantly, advances our mission to deliver transformative oncology solutions for patients worldwide."HCB101 is a potential best-in-class Fc-fusion SIRPα variant formed by the fusion of the engineered IgV domain of human signal regulatory protein α (SIRPα) with the IgG4 Fc domain. By blocking the CD47-SIRPα pathway, HCB101 could promote macrophage-mediated phagocytosis of tumor cells, thereby liberating tumor-associated antigens, and activate dendritic cells. HCB101 is designed to optimize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 exhibits selective tumor engagement with low red blood cell (RBC) binding, thereby reducing the risk of anemia and thrombocytopenia commonly associated with other CD47-targeting agents. As of now, HCB101 has demonstrated preliminary efficacy and good safety in both monotherapy and combination therapies. A phase 1b/2a multi-center clinical trial of HCB101 in combination with standard-of-care therapies in advanced solid tumors is underway in countries and regions including China and the United States.The introduction of HCB101, which holds independent intellectual property rights from HanchorBio, is expected to strengthen the company's layout in tumor immunotherapy. Henlius has established a comprehensive layout in the tumor immunotherapy field. From which, its anti-PD-1 mAb, serplulimab (Hetronifly®: Trade name in Europe) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). To date, HANSIZHUANG has been approved in nearly 40 countries and regions, including China, Europe, India and multiple Southeast Asian countries. HLX43 is the leading PD-L1-targeting ADC in clinical development globally. It has demonstrated superior anti-tumor activity with a manageable safety profile in preclinical and early clinical studies. Notably, encouraging preliminary efficacy was observed in patients with non-small cell lung cancer (NSCLC) and thymic squamous cell carcinoma (TSCC). HCB101 can activate macrophage anti-tumor activity by blocking the CD47-SIRPα signal pathway, forming potent synergy with Henlius's existing PD-1/L1 inhibitors and other core products to pioneer novel immunotherapy regimens.Looking ahead, Henlius will continue to address unmet clinical needs by leveraging it's established strengths in the field of antibodies, continuously expanding innovative potential targets, actively exploring cutting-edge technologies and therapies, strengthening cooperation on high-quality innovative assets, and delivering more high-quality, affordable innovative treatment options to patients worldwide.About HanchorBioBased in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWO), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite cancer therapies.Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.comAbout HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体:PR@Henlius.com投资者:IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看