HanchorBio Files U.S. IND for Second Trispecific Immunotherapy, HCB303
HCB303 integrates SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR biology to coordinate macrophage, T-cell and NK-cell immunity within a single FBDB™ therapeutic architecture
TAIPEI, SHANGHAI, and SAN FRANCISCO — September 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 its wholly owned subsidiary, FBD Biologics Limited, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for HCB303. Developed using HanchorBio’s proprietary FBDB™ platform, HCB303 is the Company’s second trispecific immunotherapy program to reach clinical development.
HCB303 is a humanized trispecific fusion protein designed to simultaneously target SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR pathways. By engaging three distinct pathways in a single engineered molecule, HCB303 coordinates macrophage-mediated phagocytosis, T-cell immunity, and NK-cell antitumor activity to counter complex tumor immune resistance.
“HCB303 demonstrates that the FBDB™ platform can reliably generate differentiated therapeutic architectures to address interconnected immune biology,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Rather than increasing complexity for its own sake, our strategy targets biologically connected resistance mechanisms within single, multi-targeted molecules. HCB301 and HCB303 demonstrate that this is a repeatable platform strategy—not a one-molecule experiment. This is exactly the type of differentiated asset we built the FBDB™ platform to generate, and we believe HCB303 represents a key component of our global oncology pipeline.”
The submission follows pre-IND written feedback received from the FDA in early August 2026. HanchorBio incorporated the Agency’s recommendations—including a dose-limiting toxicity framework, safety monitoring, clinical pharmacology, and a dosage-optimization strategy aligned with the FDA’s Project Optimus principles—into the final IND package.
The planned Phase 1 first-in-human study will evaluate HCB303 in adults with advanced, relapsed, or refractory solid tumors with no remaining standard treatment options. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and preliminary antitumor activity, incorporating limited accelerated escalation using a Bayesian Optimal Interval (BOIN) dose-escalation design.
“Moving from the pre-IND feedback to full IND submission within weeks highlights our disciplined execution across regulatory, CMC, non-clinical pharmacology, and clinical strategy,” added Alvin Luk, PhD, MBA, President and CMO (Group) & CEO (USA) of HanchorBio. “We look forward to advancing HCB303 into the clinic to evaluate its potential for patients with high unmet needs.”
About HCB303
HCB303 is an investigational, humanized trispecific fusion protein developed via the proprietary FBDB™ platform. Designed to simultaneously modulate the SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR immune pathways, HCB303 engages innate and adaptive antitumor immunity within a single engineered architecture.
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 next-generation trispecific program integrating SIRPα, PD-L1, and TIGIT/PVR biology; and additional programs across oncology and immune-mediated diseases. For more information, please visit HanchorBio.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development of HCB303, the timing and potential submission of an IND, initiation and design of future clinical studies, potential therapeutic characteristics and mechanisms of HCB303, 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. Regulatory feedback does not constitute approval of an IND or assurance that clinical development will proceed as planned. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康-KY向美國 FDA 提交 HCB303 IND 申請 第二款三特異性免疫療法邁向臨床開發
HCB303 整合 SIRPα/CD47、PD-L1/PD-1 與 TIGIT/PVR 生物學機制，透過FBDB™ 平台治療架構協同巨噬細胞、T 細胞與 NK 細胞免疫作用
【台北、上海、舊金山，2026 年 9 月 3 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免疫介導疾病的次世代免疫療法，今日宣布旗下全資子公司FBD Biologics Limited已向美國食品藥物管理局（FDA）提交 HCB303 的新藥臨床試驗申請（IND）。HCB303 由漢康生技自主研發的 FBDB™ 平台開發，為公司第二款進入臨床開發階段的三特異性免疫療法。
HCB303 為一款人源化三特異性融合蛋白，設計可同時靶向 SIRPα/CD47、PD-L1/PD-1 及 TIGIT/PVR 三條免疫路徑。透過單一工程化融合蛋白生物藥同時作用於三種不同路徑，HCB303 可協同巨噬細胞介導的吞噬作用、T 細胞免疫反應及 NK 細胞抗腫瘤活性，以因應複雜的腫瘤免疫抗性機制。
漢康生技創辦人暨董事長劉世高博士表示：「HCB303 展現 FBDB™ 平台可穩定建立具差異化的治療架構，以因應彼此相互關聯的免疫生物學機制。我們的策略是透過單一多靶點融合蛋白生物藥，同時針對生物學上彼此相關的抗藥性機制。HCB301 與 HCB303 顯示，這是一項可重複運用的平台策略，而非單一分子的個別嘗試。這也正是我們建立 FBDB™ 平台的核心目的——持續開發具差異化的治療資產。我們相信，HCB303 將成為公司全球腫瘤產品線中的重要一環。」
此次 IND 申請係接續漢康生技於 2026 年 8 月初收到 FDA 書面 pre-IND 回覆後提出。公司已將 FDA 的相關建議納入最終 IND 申請資料，包括劑量限制性毒性（DLT）評估架構、安全性監測、臨床藥理學，以及符合 FDA Project Optimus 原則的劑量最佳化策略。
規劃中的第一期首次人體臨床試驗（Phase 1 first-in-human study）將評估 HCB303 用於已無標準治療選擇之晚期、復發性或難治性實體腫瘤成人患者。研究將評估安全性、耐受性、藥物動力學、藥效學、免疫原性、生物標記及初步抗腫瘤活性，並採用貝葉斯最佳區間法（BOIN）劑量遞增設計，納入有限度的加速劑量遞增方式。
漢康生技集團總裁暨醫療長、漢康美國執行長陸英明博士表示：「從收到 pre-IND 回覆到於數週內完成完整 IND 申請，展現公司在法規、CMC、非臨床藥理學及臨床策略等各面向具紀律且整合的執行能力。我們期待推進 HCB303 進入臨床階段，評估其對具高度未被滿足醫療需求患者的潛力。」
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、IND 申請時程及潛在提交、未來臨床試驗的啟動與設計、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。主管機關之回饋並不構成對 IND 的核准，亦不保證臨床開發將依計畫進行。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。