HCB-303

10月5日 · 科技日报OpenAI前员工开炮：企业文化烂掉了退役机器人跳进1500℃钢水自尽 AI、智能眼镜、机器人、癌症治疗，一天看尽 🤖 AI：OpenAI后院起火，白宫设"超级智能"主管 OpenAI前员工公开开炮。自称在OpenAI工作3年多的戴维·鲁滨逊10月3日在《大西洋》月刊发文《我辞去OpenAI的工作，因为企业文化已经烂掉了》，爆料公司风险意识不足，"忙着从一次产品发布跳到下一次"，呼吁AI产业效仿航空、核能搞多重安全防护。 特朗普任命白宫AI事务主管。国家情报总监杰伊·克莱顿将领导"超级智能工作组"，120天内提交AI风险与机遇报告。同一份行政令还把联邦政府文件里的"人工智能"改称为"超级智能"，路透民调显示四分之三的美国人担心AI企业安全投入不够。 国产：StartLux开源决策模型。原点星辉用自建Auto Research管线3天搞定StartLux-Decision，一次推出0.8B到27B五档版本，38项基准里31项超过Jev，主打智能体"每一步等待都别累积"。 趣闻：OpenAI的GPT-6 Astra在《星际争霸》AI对战里打不过，中途作弊被抓包——直接搬了别人的代码（IT之家）。 👓 智能眼镜：出货量暴涨，但撞上"信任墙" Counterpoint数据：2026上半年全球AI眼镜出货量同比暴涨263%。不带显示屏的轻量款占96%绝对主流；带显示的AR款虽然小众，但增速更快（+449%），Rokid、阿里等中国厂商在这块最活跃。 国产动态：Rokid二代AI眼镜在杭州数贸会全球首秀，首发"多模态会议纪要"——麦克风收音+摄像头识图，自动拼出一篇图文并茂的会议记录。不过Rokid副总裁也承认行业有"不可能三角"，加速点可能要到2028年。 隐忧：Meta眼镜在美国被诉秘密录音、拿用户隐私画面训练AI，英国已有酒吧禁用。传闻Meta秋季要推无摄像头版智能眼镜——能看不能拍，或许是破局的方向。 🦾 机器人：国庆假期集体"上岗打工" 现实版《终结者2》。美国Figure AI让一批退役的F.02人形机器人自主走进熔炉、跳进1500℃钢水销毁——它们曾在宝马工厂干了上千小时、装了数万台汽车零部件。新一代量产在即，老机型维护不划算，"体面退役"成了新课题。 人形机器人上岗变电站。八维通×宇树在杭州数贸会亮相变电站全尺寸人形机器人，能徒手操作6kV配电间高压设备——倒闸这种一失手就闪爆的高危活，以后不用人上了。 国庆大考：智元×长隆的全球首个具身智能主题乐园迎来第一个国庆客流，300多台机器人扛住了；合肥一家"具身智能机器人小店"无人工值守，机器人当营业员，日均百单、营业额1500元；广东的机器人则在商场做咖啡、跳舞巡游，成了假期顶流。 上海：Robotex亚洲总决赛开赛，8000多名选手、29个赛项，预计15万人次到场，主办方想两年内把全球总决赛也搬来。 🎗️ 癌症治疗：两家华人药企同日传捷报 汉康HCB303获美国FDA批准进人体临床（今晨消息）。这是一款三特异性融合蛋白生物药，打实体瘤，一期临床将验证安全性并看初步抗肿瘤活性。按IQVIA数据，2025年全球肿瘤药市场约2910亿美元，还在涨。 长弘"脑内药片"把脑胶质瘤患者中位存活拉到26.2个月。做法很巧：肿瘤切除后直接把一元硬币大小的可降解药片植入病灶，30天缓慢释放、高浓度杀残余癌细胞，还绕开了血脑屏障。同一技术用在"癌王"胰脏癌的动物实验里，小鼠存活期从40天延长到120天，已拿到台美临床试验核准。 机器人跳钢水那条，你第一反应是酷还是瘆人？评论区聊聊。

汉康生技宣布HCB303 新药临床试验申请（IND） 获美国FDA批准 HCB303采用差异化TIGIT-Fc策略，旨在捕获TIGIT配体、保留CD226激活轴，并同时靶向PD-L1和CD47 计划在晚期实体瘤患者中启动一项I期首次人体、剂量递增、多区域临床试验 台北、上海和旧金山 — 2026年10月5日 — 汉康生技股份有限公司（TWSE：7827）是一家致力于开发肿瘤及免疫介导疾病新一代免疫疗法的全球临床阶段生物技术公司。公司今日宣布，美国食品药品监督管理局（FDA）已批准HCB303的新药临床试验申请（IND），汉康生技将据此启动HCB303的I期首次人体临床试验。 HCB303是汉康生技第二款进入临床开发阶段的三特异性免疫疗法，代表了一种增强抗肿瘤免疫反应的创新差异化策略。HCB303是一款基于汉康生技专有FBDB™平台设计开发的人源化三特异性融合蛋白，在单一分子架构中引入TIGIT-Fc配体捕获策略，同时靶向TIGIT/PVR、PD-L1/PD-1及SIRPα/CD47三条信号通路。 不同于主要与TIGIT结合并阻断TIGIT受体信号传导的传统抗TIGIT抗体，HCB303旨在捕获包括PVR/CD155及CD112在内的TIGIT配体。通过捕获这些配体，HCB303旨在减少TIGIT介导的抑制性信号，同时有望保留T细胞和NK细胞中CD226的表达及其相关激活信号。结合PD-L1阻断和SIRPα介导的巨噬细胞吞噬作用增强，HCB303旨在肿瘤微环境中协同调动先天免疫和适应性抗肿瘤免疫。 汉康生技创始人兼董事长刘世高博士表示：“我们认为，与传统抗TIGIT受体阻断相比，TIGIT-Fc在生物学机制上更具优势。仅通过抗TIGIT抗体阻断PVR信号，或许能够解除抑制性信号，但无法解决CD226下调的问题，而CD226对于增强T细胞和NK细胞的激活至关重要。HCB303的设计更进一步——捕获具有免疫抑制作用的TIGIT配体、保留CD226激活轴，同时阻断PD-L1和CD47通路。这正是我们建立FBDB™平台所要实现的、以生物学机制为驱动的治疗性分子架构。” 此次FDA批准是在该机构于2026年8月就pre-IND会议提供反馈后获得。汉康生技将按计划推进HCB303-ONC-101试验。这是一项I期首次人体、剂量递增、多区域研究，将纳入已无可用标准治疗选择的晚期、复发或难治性实体瘤患者。研究将评估HCB303的安全性、耐受性、药代动力学、药效动力学、免疫原性、生物标志物及初步抗肿瘤活性。 汉康生技集团总裁兼首席医学官、美国公司首席执行官Alvin Luk博士表示：“HCB303是汉康生技第二款进入临床开发阶段的三特异性免疫疗法；此次FDA批准推动HCB303从差异化的生物学假设迈入临床验证阶段。我们目前的首要任务，是严谨评估其差异化TIGIT生物学机制，以及对先天免疫和适应性免疫的协同调动，能否为患者带来具有临床意义的获益。随着HCB301已进入临床开发、HCB303也获准进入临床，我们正持续挖掘FBDB™平台的潜力，以开发作用机制各异的多特异性疗法。” 关于HCB303 HCB303是一款基于汉康生技专有FBDB™平台开发的在研人源化三特异性融合蛋白，旨在同时调控SIRPα/CD47、PD-L1/PD-1及TIGIT/PVR免疫通路，将巨噬细胞、T细胞和NK细胞的抗肿瘤免疫整合于单一工程化分子之中。 关于汉康生技 汉康生技（TWSE：7827）是一家全球临床阶段生物技术公司，专注于利用其专有FBDB™平台，发现并开发用于治疗癌症和免疫介导疾病的下一代生物制剂。 汉康生技的研发管线包括：以SIRPα为基础、针对先天免疫检查点的核心项目HCB101；靶向SIRPα、PD-L1及TGF-β生物学机制、处于临床阶段的三特异性免疫疗法HCB301；整合SIRPα/CD47、PD-L1/PD-1及TIGIT/PVR生物学机制、处于临床阶段的三特异性免疫疗法HCB303；以及其他覆盖肿瘤和免疫介导疾病的研发项目。 更多信息请访问： www.HanchorBio.com。 前瞻性声明 本新闻稿包含前瞻性声明，包括有关HCB303的开发和临床进展；未来临床研究的时间、启动、设计、实施及潜在结果；HCB303潜在的治疗特性、作用机制、安全性及抗肿瘤活性；汉康生技研发管线的开发；以及FBDB™平台的能力与潜力等声明。这些声明基于当前预期和假设，并涉及可能导致实际结果与所述内容存在重大差异的风险和不确定性。IND获FDA批准仅代表可以开展临床研究，并不构成HCB303获准上市，也不保证其临床开发的安全性、疗效、进度或成功。除适用法律另有要求外，汉康生技不承担更新前瞻性声明的义务。 投资者及媒体联系人： 电子邮箱：IRPR@hanchorbio.com 汉康生技商务拓展联系人： 电子邮箱：BD@HanchorBio.com HanchorBio Announces U.S. FDA Clearance of IND Application for HCB303, a Next-Generation Trispecific Immunotherapy HCB303 features a differentiated TIGIT-Fc strategy designed to intercept TIGIT ligands, preserving the CD226 activating axis while simultaneously targeting PD-L1 and CD47 Plans to initiate a Phase 1 first-in-human, dose-escalation, multi-regional trial in patients with advanced solid tumors TAIPEI, SHANGHAI, and SAN FRANCISCO — October 5, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for HCB303. The clearance enables HanchorBio to initiate its Phase 1 first-in-human clinical trial. HCB303 is HanchorBio's second trispecific immunotherapy to enter clinical development and represents an innovative and differentiated approach to enhance immune response against cancer. A humanized trispecific fusion protein engineered via HanchorBio’s proprietary FBDB™ platform, HCB303 incorporates a TIGIT-Fc ligand-trap strategy within a single architecture that simultaneously targets the TIGIT/PVR, PD-L1/PD-1, and SIRPα/CD47 pathways. Unlike conventional anti-TIGIT antibodies that primarily bind to TIGIT and block TIGIT receptor signaling, HCB303 is designed to intercept TIGIT ligands—including PVR/CD155 and CD112. By trapping these ligands, HCB303 is designed to reduce TIGIT-mediated inhibitory signaling while potentially preserving CD226 expression and associated activating signaling in T cells and NK cells. Combined with PD-L1 blockade and SIRPα-mediated enhancement of macrophage phagocytosis, HCB303 aims to coordinate complementary innate and adaptive antitumor immunity within the tumor microenvironment. “We believe TIGIT-Fc offers a biologically superior strategy to conventional anti-TIGIT receptor blockade,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “Simply blocking PVR signaling through an anti-TIGIT antibody may release the inhibitory signal, but it does not address the down-regulation of CD226, which is needed for enhanced activation of T and NK cells. HCB303 was designed to go further—intercepting immune-inhibiting TIGIT ligands and preserving the CD226 activating axis, while simultaneously blocking the PD-L1 and CD47 pathways. This is precisely the type of biology-driven therapeutic architecture our FBDB™ platform was built to create.” The FDA clearance follows pre-IND feedback from the agency in August 2026. HanchorBio will now proceed with its planned Phase 1 first-in-human, dose-escalation, multi-regional study (HCB303-ONC-101) in patients with advanced, relapsed, or refractory solid tumors who have no remaining standard treatment options. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and preliminary antitumor activity. “HCB303 is HanchorBio's second trispecific immunotherapy to enter clinical development, and the FDA clearance moves HCB303 from a differentiated biological hypothesis into clinical testing,” added Alvin Luk, PhD, MBA, President and CMO (Group) & CEO (USA) of HanchorBio. “Our priority now is to rigorously evaluate whether its differentiated TIGIT biology and coordinated engagement of innate and adaptive immunity translate into meaningful clinical benefit for patients. With HCB301 already in clinical development and HCB303 now cleared to enter the clinic, we are advancing the potential of our FBDB™ platform to generate mechanistically distinct multispecific therapeutics.” About HCB303 HCB303 is an investigational, humanized trispecific fusion protein developed using HanchorBio’s proprietary FBDB™ platform. It is designed to simultaneously modulate the SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR immune pathways, integrating macrophage, T-cell, and NK-cell antitumor immunity within a single engineered molecule. About HanchorBio HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing and developing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes HCB101, its lead SIRPα-based innate immune checkpoint program; HCB301, a clinical-stage trispecific immunotherapy targeting SIRPα, PD-L1, and TGF-β biology; HCB303, a clinical-stage trispecific immunotherapy integrating SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR biology; and additional programs across oncology and immune-mediated diseases. For more information, please visit: www.HanchorBio.com. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the development and clinical advancement of HCB303; the timing, initiation, design, conduct, and potential outcomes of future clinical studies; the potential therapeutic characteristics, mechanisms, safety, and antitumor activity of HCB303; the development of HanchorBio’s pipeline; and the capabilities and potential of the FBDB™ platform. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. FDA clearance of an IND permits clinical investigation to proceed but does not constitute approval of HCB303 or provide assurance regarding the safety, efficacy, timing, or success of its clinical development. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law. Investor & Media Contact: Email: IRPR@hanchorbio.com HanchorBio Business Development Contact: Email: BD@HanchorBio.com