HanchorBio Advances HCB303 Global Clinical Development with Taiwan TFDA IND Submission Following US FDA Clearance
Dual regulatory milestones position HCB303 for multi-regional Phase 1 clinical development in oncology
[Taipei, Shanghai, San Francisco | October 8, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced the submission of an Investigational New Drug (IND) to the Taiwan Food and Drug Administration (TFDA) for HCB303.
This filing follows recent IND clearance by the U.S. Food and Drug Administration (FDA), enabling HanchorBio to prepare to initiate Phase 1 clinical trials in the United States. Together, these regulatory milestones advance HCB303 into multi-regional clinical development and reflect the continued execution of HanchorBio’s global growth strategy.
Engineered through HanchorBio’s proprietary FBDB™ platform, HCB303 is a first-in-class humanized trispecific fusion protein designed to simultaneously modulate the SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR immune pathways. By engaging macrophages, T cells, and NK cells within a single therapeutic architecture, HCB303 coordinates both innate and adaptive antitumor responses.
The molecule features a differentiated TIGIT-Fc ligand-trap strategy designed to intercept key TIGIT ligands (PVR/CD155 and CD112) while preserving co-stimulatory CD226 activating signaling. Combined with PD-L1 blockade and SIRPα-mediated enhancement of macrophage phagocytosis, HCB303 represents a comprehensive multi-prolonged approach to overcoming immune evasion.
“Completing the pre-clinical development of this extremely difficult-to-make tri-functional fusion protein and moving it from regulatory filings into active clinical trial execution is a major achievement for our team,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “Following U.S. FDA IND clearance, our Taiwan filing reinforces our commitment to a seamless multi-regional development plan. Our primary focus now is disciplined execution—advancing the first-in-class HCB303 efficiently across clinical sites to generate data demonstrating whether its novel biology translates into clinical efficacy for cancer patients.”
HCB303 is HanchorBio’s second trispecific immunotherapy to enter the clinic, following HCB301, further validating the efficiency and versatility of the company’s FBDB™ platform in generating mechanistically distinct, multi-targeted immunotherapies.
About HCB303
HCB303 is an investigational, humanized trispecific fusion protein generated using HanchorBio’s proprietary FBDB™ platform. Designed to integrate innate and adaptive immune responses, HCB303 concurrently targets three key immune checkpoint pathways: SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to discovering and developing novel biologics for oncology and immune-mediated diseases using its proprietary FBDB™ platform.
HanchorBio’s clinical and preclinical portfolio includes HCB101, a novel SIRPα-based innate immune checkpoint inhibitor; HCB301, a clinical-stage trispecific immunotherapy targeting SIRPα, PD-L1, and TGF-β; HCB303, a clinical-stage trispecific molecule integrating SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR pathways; and multiple undisclosed programs.
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向TFDA提交 HCB303 IND 申請 推進三特異性免疫療法全球臨床開發
繼美國 FDA 同意 IND 進入臨床開發後，HCB303 進一步向台灣 TFDA 提出申請，持續推進全球臨床布局
【台北、上海、舊金山，2026 年 10 月 8 日】－全球臨床階段生技公司漢康生技（TWSE：7827），致力於開發應用於腫瘤及自體免疫疾病的次世代免疫療法，今日宣布向台灣衛生福利部食品藥物管理署（TFDA）提交 HCB303 新藥臨床試驗（IND）申請，供主管機關進行臨床試驗審查。HCB303 為漢康生技自主研發的三特異性融合蛋白生物藥，擬開發用於實體腫瘤治療。
HCB303 之美國 IND 已獲美國食品藥物管理局（FDA）同意進入臨床開發。此次進一步向 TFDA 提交 IND 申請，為公司推進 HCB303 全球臨床開發的下一步。
HCB303 為一款人源化三特異性融合蛋白，設計可同時調控 SIRPα/CD47、PD-L1/PD-1 及 TIGIT/PVR 三條免疫路徑，協同巨噬細胞、T 細胞及 NK 細胞的抗腫瘤免疫作用。
其中，HCB303 在 TIGIT 路徑上的設計，與傳統 anti-TIGIT 抗體有所不同。傳統 anti-TIGIT 治療多直接鎖定 TIGIT 受體；HCB303 則採用 TIGIT-Fc 配體陷阱（ligand trap）設計，可將 PVR/CD155 等會與 TIGIT 結合、傳遞免疫抑制訊號的配體先行捕捉，此一從上游攔截「踩煞車」的訊號來源，是希望在解除 TIGIT 相關免疫抑制的同時，減少對 CD226 共刺激機制的直接干擾。CD226 是 T 細胞與 NK 細胞上的重要活化受體之一，可協助維持免疫細胞的活化與抗腫瘤功能。因此，HCB303 的設計不僅著重於抑制 TIGIT 所介導的免疫抑制訊號，也希望保留 CD226 相關的免疫活化潛力，進一步支持 T 細胞及 NK 細胞的抗腫瘤免疫作用。
這項設計亦與 HCB303 其他兩項免疫調控功能形成互補。HCB303 同時結合 SIRPα/CD47 路徑以促進巨噬細胞免疫作用，以及 PD-L1/PD-1 路徑以解除 T 細胞免疫抑制，透過單一融合蛋白整合多種彼此關聯的腫瘤免疫逃脫機制，形成兼具先天性與適應性免疫調控的治療架構。
HCB303為漢康生技第二款進入臨床開發階段的三特異性融合蛋白。相較於已進入臨床一期的HCB301 將 SIRPα、PD-L1 與 TGF-β 生物學機制整合於同一分子，HCB303 則以 TIGIT/PVR 取代第三項免疫調控功能，針對另一類腫瘤免疫逃脫機制進行設計。兩項候選藥物的推進顯示，FBDB™ 平台可依據不同腫瘤免疫生物學，組合不同功能模組，持續建立具差異化的多功能免疫療法產品線。
隨著 HCB303 美國 IND 已獲 FDA 同意進入臨床開發，並進一步向台灣 TFDA 提出 IND 申請，公司持續推進 HCB303 的全球臨床開發布局，同時也進一步拓展 FBDB™ 平台於多功能免疫治療領域的應用。
關於 HCB303
HCB303 為一款處於研究階段的人源化三特異性融合蛋白，由漢康生技專有 FBDB™ 平台開發。HCB303 設計可同時調控 SIRPα/CD47、PD-L1/PD-1 及 TIGIT/PVR 免疫路徑，透過單一工程化治療架構，同時啟動先天性與適應性抗腫瘤免疫反應。
關於漢康生技
漢康生技（TWSE：7827）為一家全球臨床階段生技公司，運用自主研發的 FBDB™ 平台，專注於發明與開發用於癌症及免疫介導疾病的次世代生物藥。
漢康生技的產品線包括：核心 SIRPα 先天免疫檢查點產品 HCB101；處於臨床階段、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、PD-L1 及 TIGIT/PVR 生物學機制的次世代三特異性產品 HCB303；以及其他涵蓋腫瘤與免疫介導疾病領域的研發項目。
前瞻性聲明
本新聞稿包含前瞻性聲明，包括與 HCB303 的開發、TFDA IND 審查、未來臨床試驗的啟動與執行、HCB303 潛在治療特性與作用機制、漢康生技產品線的開發，以及 FBDB™ 平台的能力與潛力相關之聲明。
上述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本文所述內容產生重大差異的風險與不確定性。本次 IND 申請目前仍由 TFDA 審查中，並不代表 HCB303 已獲核准上市，亦不代表其安全性或療效已獲證實。HCB303 於台灣之臨床試驗須於取得適用之主管機關及人體研究倫理審查核准後，始得開始執行。除適用法律另有要求外，漢康生技無義務更新任何前瞻性聲明。