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 3, 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.
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.
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漢康-KY宣布 HCB303 IND 獲美國 FDA 同意 新一代三特異性免疫療法邁入臨床開發
HCB303 採用差異化TIGIT-Fc策略，旨在捕捉 TIGIT配體並保留 CD226活化路徑，同時靶向 PD-L1 與 CD47
規劃啟動第一期首次人體、多區域劑量遞增臨床試驗，評估晚期實體腫瘤患者
【台北、上海、舊金山，2026 年 10 月 3 日】－全球臨床階段生技公司漢康生技（TWSE：7827）致力於開發癌症及免疫介導疾病的下一代免疫療法，今日宣布，美國食品藥物管理局（FDA）已同意HCB303的新藥臨床試驗（Investigational New Drug, IND）申請，使漢康生技得以啟動 HCB303 第一期首次人體臨床試驗。
HCB303為漢康生技第二款進入臨床開發階段的三特異性免疫療法，採取創新且具差異化的策略，以增強抗癌免疫反應。HCB303為透過漢康生技自主開發FBDB™平台所設計的人源化三特異性融合蛋白，在單一分子架構中導入TIGIT-Fc配體捕捉（ligand-trap）策略，同時靶向TIGIT/PVR、PD-L1/PD-1及SIRPα/CD47三條免疫調控路徑。
不同於傳統抗TIGIT抗體主要與TIGIT結合並阻斷其受體訊號，HCB303的設計旨在捕捉TIGIT 配體，包括 PVR/CD155 及 CD112。透過捕捉這些配體，HCB303 旨在降低 TIGIT 所介導的抑制性訊號，同時可能保留T細胞及自然殺手細胞的CD226表現及其相關活化訊號。結合PD-L1阻斷，以及透過SIRPα增強巨噬細胞吞噬作用，HCB303旨在腫瘤微環境中協同先天性與適應性抗腫瘤免疫反應。
漢康生技創辦人暨董事長劉世高博士表示：「我們相信，相較於傳統抗TIGIT受體阻斷策略，TIGIT-Fc 在生物學機制上具有差異化潛力。單純透過抗TIGIT抗體阻斷PVR訊號，雖可能解除抑制性訊號，卻未能進一步處理CD226下調的問題，而CD226對於增強T細胞與NK細胞的活化相當重要。HCB303的設計進一步捕捉具有免疫抑制作用的TIGIT配體，在保留CD226活化路徑的同時，也同步阻斷PD-L1與CD47路徑。這正是我們建立FBDB™平台所希望實現的、以生物學機制為基礎的治療架構。」
此次FDA同意IND申請，是繼漢康生技於2026年8月取得FDA pre-IND回饋後的進一步進展。公司接下來將依計畫啟動HCB303 第一期首次人體、多區域劑量遞增臨床試驗（HCB303-ONC-101），納入已無其他標準治療選項的晚期、復發性或難治性實體腫瘤患者。該研究將評估 HCB303 的安全性、耐受性、藥物動力學、藥效動力學、免疫原性、生物標記，以及初步抗腫瘤活性。
漢康生技總裁暨集團醫療長、美國子公司執行長陸英明博士表示：「HCB303是漢康生技第二款進入臨床開發階段的三特異性免疫療法，此次FDA同意IND，使HCB303從生物學假說正式邁入臨床驗證階段。目前我們的首要任務，是嚴謹評估其差異化生物學機制，以及協同先天性與適應性免疫的設計，能否進一步轉化為對患者具有意義的臨床受益。隨著HCB301已進入臨床開發，以及HCB303現已獲准進入臨床，我們正持續推進FBDB™平台開發具不同作用機制之多特異性療法的潛力。」
關於 HCB303
HCB303是漢康生技運用自主開發FBDB™平台所開發的試驗性人源化三特異性融合蛋白，旨在同步調控SIRPα/CD47、PD-L1/PD-1及TIGIT/PVR三條免疫路徑，透過單一工程化分子整合巨噬細胞、T 細胞與自然殺手細胞（NK cell）的抗腫瘤免疫作用。
關於漢康生技
漢康生技（TWSE：7827）為全球臨床階段生技公司，運用自主開發的FBDB™平台，專注於癌症及免疫介導疾病之下一代生物藥的創新與開發。
漢康生技產品管線包括：以SIRPα為基礎、靶向先天免疫檢查點的核心候選藥物HCB101；已進入臨床階段、靶向SIRPα、PD-L1 及TGF-β生物學機制的三特異性免疫療法HCB301；整合SIRPα/CD47、PD-L1/PD-1 及TIGIT/PVR 生物學機制的臨床階段三特異性免疫療法 HCB303；以及其他涵蓋癌症與免疫介導疾病的研發項目。
前瞻性聲明
本新聞稿包含前瞻性聲明，包括有關 HCB303 的開發及臨床推進；未來臨床研究的時程、啟動、設計、執行及潛在結果；HCB303 潛在的治療特性、作用機制、安全性及抗腫瘤活性；漢康生技產品管線的開發；以及 FBDB™ 平台的能力與潛力等相關陳述。
此類聲明係基於目前的預期與假設，並涉及可能導致實際結果與所述內容存在重大差異的風險與不確定性。FDA 同意 IND 代表該候選藥物得以進行臨床研究，但不代表 FDA 已核准 HCB303，亦不保證其安全性、有效性、臨床開發時程或最終成功。除適用法律另有規定外，漢康生技無義務更新任何前瞻性聲明。