HanchorBio Inc., a biotechnology company specializing in next-generation immunotherapies, presented significant new data today at the 13th International Conference of the Federation of Asian Clinical Oncology (FACO 2025), held in Shanghai, Mainland China. At this prestigious scientific gathering, HanchorBio shared interim results from its ongoing Phase 1 study evaluating HCB101, a novel SIRPα-engineered Fc fusion protein designed to target the CD47-SIRPα interaction, a well-validated immune checkpoint relevant in multiple cancer types. 瀚科生物(HanchorBio)是一家专注于下一代免疫疗法的生物技术公司,该公司今天在第十三届亚洲临床肿瘤学会联合会(FACO 2025)国际会议上发布了重要的新数据,会议在中国大陆上海举行。在这场备受瞩目的科学盛会上,瀚科生物分享了其正在进行的 I 期研究的中期结果,该研究评估了 HCB101——一种新型的 SIRPα 工程化 Fc 融合蛋白,旨在靶向 CD47-SIRPα 相互作用,这是一个在多种癌症类型中具有重要验证的免疫检查点。The presentation highlighted favorable safety findings, robust receptor occupancy, and early signals of clinical efficacy, underpinning the company’s broader ambition to advance innovative immunotherapy treatments for high unmet medical needs in oncology.. 报告强调了良好的安全性发现、强大的受体占有率以及临床疗效的早期信号,支撑了该公司推进创新免疫疗法治疗肿瘤领域高度未满足医疗需求的更广泛目标。The multicenter, multinational, open-label Phase 1 study (NCT05892718) enrolled 49 patients with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma across Taiwan, China, and the United States. Patients received escalating flat doses ranging from 0.08 mg/kg up to 18.00 mg/kg administered weekly. 多中心、跨国、开放标签的1期研究(NCT05892718)在台湾、中国大陆和美国招募了49名晚期实体瘤或复发/难治性非霍奇金淋巴瘤患者。患者每周接受剂量递增的固定剂量治疗,范围从0.08 mg/kg至18.00 mg/kg。Key results as of July 10, 2025, show an excellent safety profile: only one dose-limiting toxicity (DLT), a transient grade 3 thrombocytopenia, was observed at the 2.56 mg/kg level. Importantly, no treatment-related severe anemia or cytopenias—common adverse events associated with prior CD47-targeting agents—occurred even at the highest tested doses. 截至2025年7月10日的关键结果显示出了极佳的安全性:在2.56毫克/千克的剂量水平上,仅观察到一例剂量限制性毒性(DLT),即短暂的3级血小板减少症。重要的是,即使在最高测试剂量下,也未出现与治疗相关的严重贫血或细胞减少症——这些是与先前CD47靶向药物相关的常见不良事件。At doses of at least 1.28 mg/kg, more than 90% CD47 receptor occupancy was recorded, indicating strong target engagement. Two patients achieved confirmed partial responses, one each in head and neck squamous cell carcinoma and non-Hodgkin lymphoma, while multiple other patients maintained durable disease control.. 在剂量至少为 1.28 毫克/千克时,记录到超过 90% 的 CD47 受体占有率,表明靶点结合能力强。两名患者获得了确认的部分缓解,分别患有头颈部鳞状细胞癌和非霍奇金淋巴瘤,而多位其他患者维持了持久的疾病控制。These encouraging early outcomes distinguish HCB101 as a differentiated CD47-SIRPα immune checkpoint inhibitor. It is a 3.5th-generation, affinity-optimized fusion protein that leverages HanchorBio’s proprietary FBDB™ platform. HCB101 features a cytopenia-sparing design and strong antibody-dependent cellular phagocytosis (ADCP), aiming to both preserve safety and drive durable immune tumor responses. 这些令人鼓舞的早期成果使 HCB101 成为一种与众不同的 CD47-SIRPα 免疫检查点抑制剂。它是一款 3.5 代、亲和力优化的融合蛋白,依托于 HanchorBio 专有的 FBDB™ 平台。HCB101 具有避免细胞减少症的设计和强大的抗体依赖性细胞吞噬作用 (ADCP),旨在兼顾安全性的同时激发持久的免疫肿瘤反应。Across preclinical models, HCB101 demonstrated robust activity in over 80 patient-derived and cell-line-derived xenografts encompassing various solid and hematologic cancers. Clinically, besides observed monotherapy activity, the agent already showed a 100% confirmed partial response rate in combination with ramucirumab and paclitaxel for second-line gastric cancer, and strong efficacy signals in first-line triple-negative breast cancer and second-line head and neck squamous cell carcinoma in ongoing studies.. 在各种临床前模型中,HCB101在超过80种患者来源和细胞系来源的异种移植模型中表现出强大的活性,涵盖多种实体瘤和血液癌症。在临床上,除了观察到的单药活性外,该药物在与雷莫芦单抗和紫杉醇联合用于二线胃癌治疗时已显示出100%的确证部分缓解率,并在正在进行的研究中,对一线三阴性乳腺癌和二线头颈部鳞状细胞癌显示出强烈的疗效信号。Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio, commented that the FACO 2025 presentation reflects the company’s sustained commitment to bringing transformative therapies to global oncology. Led by industry veterans with decades of experience in biologics development, HanchorBio is applying innovative protein engineering and AI-driven design to address the complex challenges of immune evasion in cancer. 刘特博士,汉康生物董事长、首席执行官兼创始人评论道,FACO 2025 的演讲反映了公司持续致力于将变革性疗法带给全球肿瘤学领域。汉康生物由拥有数十年生物制品开发经验的行业资深人士领导,正在运用创新的蛋白质工程和人工智能驱动的设计,来应对癌症免疫逃逸的复杂挑战。The successful demonstration of HCB101’s safety, pharmacokinetics, and initial efficacy proves the platform’s potential and has paved the way for advancing this product into expansion cohorts and combination trials with established cancer therapies.. HCB101的安全性、药代动力学和初步疗效的成功证明了该平台的潜力,并为将该产品推进到扩展队列以及与已确立的癌症疗法联合试验铺平了道路。Looking ahead, HanchorBio intends to proceed with expanded clinical evaluation of HCB101, both as monotherapy and in rational combinations, to maximize therapeutic benefit for patients facing cancers with high unmet medical needs. By addressing safety limitations seen with earlier CD47 inhibitors and broadening immune activation, HCB101 aims to reset the standard for CD47-targeted immune-oncology agents. 展望未来,HanchorBio 计划推进 HCB101 的扩展临床评估,包括单药治疗和合理联合用药,以期为面临高度未满足医疗需求的癌症患者带来最大化的治疗效益。通过解决早期 CD47 抑制剂所表现出的安全性局限并增强免疫激活,HCB101 旨在重新设定 CD47 靶向免疫肿瘤药物的标准。HanchorBio’s success also contributes to the global profile of Asian biotech innovation, underscoring the region’s increasing role in advancing next-generation biologic drug discovery and development, especially in the competitive immuno-oncology sector.. HanchorBio的成功也提升了亚洲生物技术创新的全球形象,突显了该地区在推动下一代生物药物发现和开发方面日益增长的作用,尤其是在竞争激烈的免疫肿瘤领域。