HCB101

汉康生技将于5月11日举办 业绩发表会， 为计划中的台湾创新板 上市做准备 临床阶段生物科技公司将介绍平台、核心管线资产及合作进展 【台北、上海、旧金山｜2026年5月8日】——汉康生技，一家致力于开发肿瘤及自身免疫疾病下一代免疫疗法的全球临床阶段生物技术公司，今日宣布将于5月11日举办投资者说明会，为其计划于本月稍晚在台湾创新板的上市做准备。 本次说明会预计将重点介绍汉康生技专有的FBDB™平台、核心临床项目的进展、业务拓展活动以及公司为进入下一阶段上市生物科技公司所做的更广泛增长战略。 汉康生技由创始人、董事长兼首席执行官刘世高博士于2020年创立，专注于开发旨在应对先天与适应性免疫通路复杂疾病生物学的多功能生物药。公司目前拥有八个处于研究、开发及工艺开发阶段的候选药物，其中HCB101和HCB301是推进最深入的两个临床阶段项目。 HCB101是一款AI引导、结构工程化的SIRPα-IgG4 Fc融合蛋白，靶向CD47-SIRPα轴，目前正在一项正在进行的Ib/IIa期研究中进行评估，已在多个实体瘤领域（包括头颈癌、胃癌、三阴性乳腺癌和结直肠癌）显示出抗肿瘤活性。该项目已获得美国食品药品监督管理局授予的胃癌孤儿药资格认定。 HCB301是一款三功能融合蛋白，旨在同时针对肿瘤中的三条关键免疫逃逸通路。其一期临床试验已在美国、中国大陆及台湾地区启动。 “我们的战略核心是开发具有全球开发和合作潜力的差异化‘同类最佳’和‘同类首创’药物项目，”汉康生技创始人、董事长兼首席执行官刘世高博士表示。“我们相信HCB101和HCB301代表了我们平台如何生成创新生物药以解决当前肿瘤免疫疗法重要局限的两个鲜明例证。” 汉康生技也在早期业务拓展方面建立了良好记录。2024年，公司就HCB101签署了一项总潜在价值最高达2.02亿美元的授权协议，授予复宏汉霖在中国大陆及其他特定区域的独家开发和商业化权利。公司目前也在与多家国际制药公司进行全球合作洽谈，其中包括正在进行尽职调查的合作伙伴。 在肿瘤领域之外，汉康生技还在推进基于FBDB™平台的其他生物候选药物，包括用于自身免疫疾病的HCB206，预计将向临床开发阶段推进。2026年4月，公司还宣布与阳明交通大学合作，以拓展其在AI辅助药物发现方面的能力。 汉康生技已获得包括安富大健康、及Panacea Venture在内的机构投资者的支持。刘世高博士目前持有公司约40%的股份，体现了重要的创始人持股及与股东的长期利益一致性。 计划中的台湾创新板上市将是汉康生技从私人资助的研发阶段生物科技公司转型为面向更广泛资本市场的临床阶段公司的一个重要里程碑。公司计划持续推进HCB101和HCB301的研发，寻求更多战略合作，并准备在自身免疫疾病领域提交未来的新药临床试验申请，以扩展其产品管线及全球开发版图。 关于汉康生技 汉康生技（股票代码：7827.TPEx）是一家全球临床阶段的生物技术公司，专注于肿瘤免疫学及免疫介导疾病领域，总部设于台北（台湾地区），并在上海及美国旧金山湾区设有运营机构。公司专有的Fc基础设计生物药平台能够设计具有多种靶向模式的多功能生物药，旨在通过结构化的安全性、暴露及工艺控制，调节先天性与适应性免疫通路。汉康生技正通过创新的分子工程与可规模化的CMC策略，推进一系列差异化生物药管线，致力于解决尚未被满足的重大医疗需求。 更多信息，敬请访问： www.HanchorBio.com HanchorBio to Hold May 11 Investor Presentation Ahead of Planned Taiwan Innovation Board Listing Clinical-stage biotech to outline platform, lead pipeline assets, and partnering progress ahead of planned market debut [Taipei, Shanghai, San Francisco | May 8, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that it will hold an investor presentation on May 11 ahead of its planned listing on the Taiwan Innovation Board later this month. The presentation is expected to highlight HanchorBio’s proprietary FBDB™ platform, progress across its lead clinical programs, business development activity, and broader growth strategy as the company prepares for its next phase as a publicly listed biotech. Founded in 2020 by Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer, HanchorBio is focused on developing multifunctional biologics designed to address complex disease biology across innate and adaptive immune pathways. The company currently has eight drug candidates across research, development, and process development, with HCB101 and HCB301 as its two most advanced clinical-stage programs. HCB101, an AI-guided, structurally engineered SIRPα-IgG4 Fc fusion protein targeting the CD47-SIRPα axis, is being evaluated in an ongoing Phase 1b/2a study and has demonstrated antitumor activity across multiple solid tumor settings, including head and neck, gastric, triple-negative breast, and colorectal cancers. The program has received the U.S. Food and Drug Administration Orphan Drug Designation for gastric cancer. HCB301 is a tri-functional fusion protein designed to address three key immune escape pathways in tumors. Phase 1 clinical trials have been initiated in the United States, Mainland of China, and Taiwan region of China. “Our strategy is centered on building differentiated best-in-class and first-in-class drug programs with global development and partnering potential,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “We believe HCB101 and HCB301 represent two distinct examples of how our platform can generate novel biologics designed to address important limitations in current immuno-oncology approaches.” HanchorBio has also established an early business development track record. In 2024, the company entered into a licensing agreement for HCB101 with a total potential value of up to US$202 million, granting Henlius exclusive development and commercialization rights in Mainland of China and certain other territories. The company is also engaged in global partnering discussions with multiple international pharmaceutical companies, including certain partners conducting due diligence. Beyond oncology, HanchorBio is advancing additional biologic candidates based on the FBDB™ platform, including HCB206 for autoimmune diseases, which is expected to progress toward clinical development. In April 2026, the company also announced a collaboration with Yang Ming Chiao Tung University to expand its capabilities in AI-enabled drug discovery. HanchorBio has attracted backing from institutional investors, including Anfu Healthcare, and Panacea Venture. Dr. Liu currently holds approximately 40% of the company’s shares, reflecting significant founder ownership and long-term alignment with shareholders. The planned Taiwan Innovation Board listing would mark an important milestone in HanchorBio’s transition from a privately funded R&D-stage biotech to a broader capital-markets-facing clinical-stage company. The company intends to continue advancing HCB101 and HCB301, pursue additional strategic collaborations, and prepare future IND submissions in autoimmune disease as it expands its pipeline and global development footprint. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies.  For more information, please visit: https://www.HanchorBio.com

汉康生技与河北清华 发展研究院 展开 HCB101作用 机制研究合作 此项合作将探讨 HCB101 抗肿瘤活性背后所涉及的先天与适应性免疫途径 【台北、上海、旧金山｜2026年5月7日】汉康生技（TPEx：7827）为一家致力于开发次世代免疫疗法、聚焦肿瘤与自体免疫疾病的全球临床阶段生技公司，今日宣布，与河北清华发展研究院展开合作，进一步解析 HCB101 的抗肿瘤作用机制与转译生物学。HCB101 为公司以 AI 辅助、经结构工程设计的 Fc 融合蛋白，靶向 CD47-SIRPα。 此次合作旨在聚焦于体内研究，深入了解 HCB101 抗肿瘤活性背后的作用机制（mechanism of action）与作用模式（mode of action），研究范围涵盖肿瘤免疫、免疫细胞功能、抗原呈现、巨噬细胞介导之吞噬作用、下游免疫讯号传递，以及血液学相关生物学。此项研究预期将进一步强化奠定 HCB101开发的科学基础。 汉康生技创办人、董事长暨首席执行官刘世高博士表示，深度的科学探讨非常重要，随着 HCB101 持续推进开发，汉康致力于建立的不只是临床数据，亦包括更深入扎实的机制性理解，以厘清此分子如何在作用于肿瘤细胞的同时，仍能避免影响正常血球。汉康选择与河北清华发展研究院合作，是因为其具备卓越的研究能力，以及在相关转译模型中探讨这些复杂问题所需的科学严谨性。 刘博士进一步表示，汉康相信具差异化的药物建立在具差异化的科学之上。此次合作旨在更精准地界定其生物学机制，从先天免疫活化与抗原呈现，到下游适应性免疫反应。这类深入的转译研究可望优化生物标记策略、强化联合治疗的科学依据，并进一步厘清 HCB101 更广泛的治疗潜力，支持汉康在扩展此项目时做出更精准的决策。 肿瘤免疫领域资深专家傅阳心教授指出，HCB101 是转化研究领域极具科学价值的创新分子。该药物依托差异化设计的 CD47-SIRPα 靶向作用机制，精准契合肿瘤免疫与效应细胞生物学领域的核心研究方向，具备重要的科研探索意义。 河北清华发展研究院相关科研负责人表示，研究院十分期待与汉康生技达成深度合作，依托系统化、规范化的研究方案，全面深挖 HCB101 在各类实验模型中的作用机理。项目将围绕肿瘤免疫调控、免疫信号传导、抗原呈递机制及效应细胞功能等关键维度开展系统性研究，助力科研团队进一步厘清 CD47-SIRPα 信号通路的调控逻辑，明晰其对抗肿瘤免疫应答的影响机制，为相关领域基础研究与临床转化应用筑牢理论支撑。 此次合作也反映出汉康生技更广泛的策略，即结合临床开发与严谨的转译研究，以支持次世代免疫治疗项目的推进。 关于 HCB101 HCB101 为汉康生技以 FBDB™ 平台理性设计开发之 SIRPα–IgG4 Fc 融合蛋白，旨在选择性阻断 CD47–SIRPα 先天免疫检查点，同时降低血液学毒性。不同于早期的抗 CD47，HCB101 在保留巨噬细胞介导抗肿瘤活性的同时，降低对红细胞 CD47 的结合能力，以克服过去限制该疗法发展的关键挑战。 透过 AI 辅助结构建模，HCB101 对肿瘤细胞上的 CD47 具差异化结合特性，并维持对红细胞 CD47 的低亲和力。其安全性、受体占有率与药理特性，皆有利于与既有肿瘤治疗方案整合。目前 HCB101 正于胃癌、大肠直肠癌及头颈癌等适应症持续进行剂量递增与临床二期扩展研究。 综合上述特质，HCB101 已定位为具备差异化的先天免疫检查点骨干（Backbone），并具备横跨实体肿瘤与血液肿瘤的广泛潜力。 关于河北清华发展研究院 河北清华发展研究院成立于 2002 年，是河北省人民政府与清华大学共建的事业法人单位，设有石家庄总部和廊坊、固安两个基地。研究院牢牢把握京津冀协同发展战略和雄安新区建设的重大历史机遇，对标对表世界一流新型研发机构建设，充分发挥河北区位、产业、市场优势和清华大学创新资源与创新组织优势，重点布局碳中和、生命健康、智能装备与电子信息技术、数字经济、工业设计五大方向，构建从“科技研发—概念验证—中试熟化—孵化转化”的全链条科创范式，致力于打造全国有影响力的区域融合创新中心。 关于汉康生技 汉康生技（股票代码：7827.TPEx）是一家全球临床阶段的生物技术公司，专注于肿瘤免疫学及自体免疫疾病领域，研发总部设于台北，并在上海及美国旧金山湾区设有运营办公室。公司由一支在生物药发现与全球开发方面拥有丰富成功经验的资深团队领导，致力于重塑癌症治疗格局。汉康生技专有的Fc基础设计生物药平台能够开发具有多种靶向模式的多功能生物药，旨在激活先天性与适应性免疫通路，以突破当前抗PD-1/L1免疫疗法的局限。该平台已在多个体内肿瘤动物模型中成功获得概念验证数据。通过差异化的分子研发策略与可规模化的CMC工艺开发，汉康生技正推进一系列创新生物药管线，致力于解决尚未被满足的重大医疗需求。 END HanchorBio Launches HCB101 Mechanism Collaboration Study with the Institute of Tsinghua University, Hebei Research collaboration will investigate innate and adaptive immune pathways underlying the antitumor activity of HCB101 [Taipei, Shanghai, San Francisco | May 7, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced a research collaboration with the Institute of Tsinghua University, Hebei, to further characterize the antitumor mechanisms and translational biology of HCB101, the Company’s AI-guided, structurally engineered, Fc-based fusion protein targeting the CD47-SIRPα axis. The collaboration is intended to deepen scientific understanding of the mechanisms and mode of action (MOA) underlying HCB101’s antitumor activity through focused in vivo studies spanning tumor immunity, immune cell function, antigen presentation, macrophage-mediated phagocytosis, downstream immune signaling, and hematologic biology. The work is expected to further strengthen the scientific foundation supporting the development of HCB101. “Scientific depth matters,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “As HCB101 continues to advance, we want to build not only clinical evidence, but also a stronger mechanistic understanding of how this molecule engages tumor cells while avoiding effects on normal blood cells. We chose to work with the Institute of Tsinghua University, Hebei, because of its strong research capabilities and the scientific rigor needed to investigate these complex questions in relevant translational models.” Dr. Liu added, “At HanchorBio, we believe differentiated medicines are built on differentiated science. This collaboration is intended to help define the biology with greater precision, from innate immune activation and antigen presentation to downstream adaptive immune responses. Deep translational work like this can sharpen biomarker strategy, strengthen the combination rationale, and further clarify the broader therapeutic potential of HCB101 to support smarter development decisions as we expand the program.” Professor Yangxin Fu, a senior expert in tumor immunology, noted that HCB101 represents an innovative molecule of significant scientific value for translational research. Built upon a differentiated CD47-SIRPα-targeting mechanism, HCB101 is closely aligned with key research directions in tumor immunity and effector-cell biology and carries important exploratory value for scientific investigation. A research representative from the Institute of Tsinghua University, Hebei, commented: “The Institute looks forward to working closely with HanchorBio through a systematic and standardized research program to further investigate the mechanism of HCB101 across relevant experimental models. The project will focus on key dimensions including tumor immune regulation, immune signaling, antigen presentation, and effector-cell function, with the goal of helping research teams better clarify the regulatory logic of the CD47-SIRPα signaling pathway and its impact on antitumor immune responses, thereby strengthening the theoretical foundation for basic research and clinical translation in this field.” The collaboration reflects HanchorBio’s broader approach of integrating clinical development with rigorous translational research to support next-generation immunotherapy programs. About HCB101 HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy. About the Institute  of Tsinghua University, Hebei The Institute of Tsinghua University, Hebei, was established in 2002 as a public institution jointly established by the Hebei Provincial People’s Government and Tsinghua University. With its headquarters in Shijiazhuang and additional bases in Langfang and Gu’an, the Institute is positioned around the coordinated development strategy of the Beijing-Tianjin-Hebei region and the development of Xiong’an New Area. The Institute focuses on building a world-class new-type research and development institution by leveraging Hebei’s regional, industrial, and market advantages together with Tsinghua University’s innovation resources and organizational strengths. Its key areas of focus include carbon neutrality, life and health, intelligent equipment and electronic information technology, digital economy, and industrial design. The Institute aims to establish a full-chain innovation model spanning technology research and development, proof of concept, pilot-scale maturation, incubation, and translation, with the goal of becoming an influential regional integrated innovation center in China. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies. END