HanchorBio Announces FDA Type C Meeting Minutes Supporting a Clear Development Path for HCB101 in Second-Line Gastric/GEJ Cancer
Official minutes support Phase 2 lead-in dose/schedule optimization followed by an OS-primary confirmatory strategy in HanchorBio’s lead clinical anchor indication
[Taipei, Shanghai, San Francisco | June 30, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced receipt of the official minutes from its recent U.S. Food and Drug Administration (FDA) Type C meeting regarding the post-Phase 1 development strategy for HCB101.
The official meeting minutes provide HanchorBio with a clear and workable FDA-facing development direction for HCB101 in second-line gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma, which the Company views as the lead clinical anchor for potential registrational path for the program. The purpose of the meeting was to meaningfully reduce strategic uncertainty around HCB101’s lead development path in second-line GC/GEJ cancer. Based on the FDA feedback, the Company plans to proceed with a staged combination dose/schedule exploration strategy in the ongoing Phase 1b/2a HCB101-201 multi-cohort study (NCT06771622), intended to support the selection of candidate regimens for a randomized Phase 2b lead-in, followed by the confirmatory Phase 3 study.
HCB101 is HanchorBio’s engineered SIRPα-IgG4 Fc fusion protein designed to selectively block CD47–SIRPα “don’t eat me” signaling while reducing red-blood-cell binding. The program is being developed as a myeloid-enhancing immune backbone for rational combination therapy, with second-line GC/GEJ cancer as the lead development focus.
The FDA meeting minutes document that the Agency did not object to HanchorBio’s proposal to shift the near-term development focus away from a monotherapy RP2D declaration and toward a prospective optimization of the every-2-week (Q2W) combination dose/schedule. The minutes also reflect FDA’s feedback that continued combination dose exploration with ramucirumab and paclitaxel is appropriate, and that a confirmatory Phase 3 strategy (with OS as the primary endpoint) is the appropriate registrational direction in this setting.
“The FDA meeting minutes are important because they provide a clear and workable regulatory direction for HCB101 in second-line gastric/gastroesophageal junction cancer, while also reinforcing the broader strategic direction of HanchorBio,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “We view second-line gastric/gastroesophageal junction cancer as the clinical anchor for our myeloid-enhancer platform — a setting where we can establish a disciplined development path and build the foundation for expansion into other myeloid-rich tumors. We believe this outcome supports a clear next step: optimize the dose for the Q2W schedule first, then advance to the Phase 2b lead-in followed by the Phase 3 study in a clinically defined setting with a comparator arm of the globally established standard-of-care regimen. Over time, we also believe this platform can extend beyond CD47–SIRPα biology into broader multi-axis tumor microenvironment modulation, and potentially beyond oncology into autoimmune, cardiovascular, and CNS diseases.”
In the meeting minutes, FDA indicated that the Company’s proposed staged Q2W combination regimen exploration in the ongoing Phase 1b/2a HCB101-201 multi-cohort study appears reasonable at the current stage of development, subject to full protocol submission and review. The minutes also clarify key elements of the future registrational path in second-line GC/GEJ cancer, including prior trastuzumab deruxtecan for HER2-positive patients, where locally approved and clinically appropriate, with any exceptions prospectively documented; and conduct of the future study in a multiregional framework relevant to U.S. patients. In addition, the minutes support prospective handling of biomarker-defined prior targeted therapy in the study population, aligned with current treatment practice for HER2-positive and CLDN18.2-positive disease.
“We believe second-line gastric/gastroesophageal junction cancer is the right lead development setting for HCB101 because it offers a clinically defined population, a globally established standard-of-care regimen, interpretable endpoints, and a focused registrational path,” added Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Our objective has been to align the program around the most decision-useful next step. The FDA meeting minutes help clarify the path, supporting prospective Phase 2 lead-in dose/schedule optimization in combination with ramucirumab and paclitaxel, followed by a confirmatory Phase 3 study. Together with HCB101’s orphan drug designation in gastric cancer, this gives us a clearer framework to execute the program in a disciplined and registration-oriented manner.”
As part of this optimization strategy, HanchorBio plans to continue evaluating not only safety, pharmacokinetics, pharmacodynamics, and receptor occupancy, but also treatment deliverability in the intended ramucirumab and paclitaxel regimen, including the practical impact of paclitaxel dose modification, consistent with the FDA feedback. The Company believes this is important for disciplined regimen selection in second-line GC/GEJ cancer.
HanchorBio plans to incorporate the FDA’s feedback into the ongoing development of HCB101, including protocol refinement for dose/schedule exploration, the randomized Phase 2b lead-in dose optimization, safety characterization, and the Phase 2/3 master protocol statistical framework for future clinical study submissions.
About HCB101
HCB101 is HanchorBio’s differentiated engineered SIRPα-IgG4 Fc fusion protein designed to selectively block CD47–SIRPα signaling while reducing red-blood-cell binding. By restoring macrophage-mediated tumor-cell phagocytosis and supporting antigen presentation, HCB101 is being developed as a myeloid-enhancing immune backbone for rational combination therapy across selected solid tumors.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical development outcomes, regulatory interactions, regulatory decisions, protocol development, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康生技宣布取得 FDA Type C 會議正式紀錄，支持 HCB101 於二線胃癌／胃食管結合部癌之明確開發路徑
會議紀錄支持先進行第二期導入階段之劑量／給藥時程優化，後續推進以總存活期（OS) 為主要終點之確證性開發策略，強化漢康生技主要臨床錨定適應症布局
【台北、上海、舊金山｜2026 年 6 月 30 日】— 漢康生技（TWSE：7827）為一家全球臨床階段生物技術公司，致力於開發次世代腫瘤與自體免疫疾病免疫療法。公司今（30）日宣布，已收到美國食品藥物管理局（FDA）近期就 HCB101 一期臨床試驗後續開發策略召開之 Type C 會議正式紀錄。
本次正式會議紀錄釐清了 HCB101 後續在二線胃癌／胃食道交界部癌的開發方向，並為公司後續與 FDA 的溝通提供清楚且可執行的依據。公司將此適應症視為 HCB101 後續推進註冊臨床開發的重要臨床基礎。本次會議旨在進一步釐清 HCB101 於二線 GC/GEJ 癌症中的主要開發路徑，並降低後續臨床開發與法規策略的不確定性。根據 FDA回饋，公司計畫於目前進行中的 HCB101-201 多隊列一b／二a 期臨床研究（NCT06771622）中，採取分階段方式探索聯合治療的劑量與給藥時程，作為後續二b期導入候選治療方案選定的依據，並接續推進以註冊申請為目標的第三期臨床試驗。
HCB101 為漢康生技自主開發之工程化 SIRPα-IgG4 Fc 融合蛋白，設計目的在於選擇性阻斷 CD47–SIRPα「別吃我」訊號，同時降低與紅血球結合的風險。該項目正被開發為聯合治療中的免疫治療骨幹，透過增強髓系免疫反應，與其他標準治療或免疫療法形成互補，並以二線胃癌／胃食道交界部癌作為主要臨床開發重點。
FDA 會議紀錄顯示，其對漢康生技將近期開發重點由單藥治療 RP2D（第二期建議劑量）宣告，轉向預先規劃並系統性評估每兩週一次（Q2W）聯合治療劑量與給藥時程之規劃，未提出異議。會議紀錄亦指出，持續探索 HCB101 與雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel）之聯合治療劑量具合理性；同時，在此治療情境下，後續以總存活期（OS）作為主要終點、並推進以註冊申請為目標的第三期臨床試驗，為合適的開發方向。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「FDA 會議紀錄的重要性在於，其為 HCB101 於二線胃癌／胃食管結合部癌的開發，提供了清楚且可執行的法規方向，同時也進一步強化漢康生技整體策略方向。我們將胃癌／胃食道交界部癌視為公司髓系免疫增強平台的重要臨床錨定適應症；在這一治療領域中，我們能夠建立嚴謹的開發路徑，並為未來拓展至其他髓系免疫豐富的腫瘤奠定基礎。我們相信，本次 FDA 會議紀錄為 HCB101 的後續開發提供了明確的下一步，先優化 Q2W 給藥時程下的劑量，再推進至二b期導入階段，並接續進入以全球既有標準治療作為對照組的第三期臨床試驗。長期而言，我們也相信此平台具備從 CD47–SIRPα 生物學機制，延伸至更廣泛、多軸向腫瘤微環境調控的潛力，並可能進一步拓展至腫瘤以外的自體免疫、心血管及中樞神經系統疾病領域。」
於會議紀錄中，FDA 表示，公司擬於目前進行中的 HCB101-201 多隊列一b／二a期臨床研究中，採取分階段 Q2W 聯合治療方案探索，在目前開發階段看來具合理性；後續將依完整試驗計畫書提交與審查程序推進。會議紀錄亦敘明未來於二線胃癌／胃食管結合部癌註冊開發路徑中的關鍵要素，包括 HER2 陽性病人若於當地已核准且臨床上合適，應先接受過 trastuzumab deruxtecan 治療；如有例外情形，則應於試驗設計階段預先說明並記錄。此外，未來試驗將採取與美國病人族群評估的多區域研究架構。會議紀錄也支持公司在研究族群設計中，預先規劃並處理病人既往接受生物標記相關標靶治療的情形，以符合目前 HER2 陽性及 CLDN18.2 陽性疾病的臨床治療實務。
漢康生技總裁暨集團醫療長、美國公司執行長陸英明博士表示：「我們相信二線胃癌／胃食管結合部癌是 HCB101 合適的主要開發方向。這一治療領域已有明確的病人族群與全球既有標準治療，也具備較清楚的臨床評估指標，有助於公司以更聚焦、具註冊導向的方式推進後續開發。我們的目標一直是讓 HCB101 的後續開發聚焦於最關鍵的臨床與法規決策節點。FDA 會議紀錄有助於進一步明確開發路徑，支持公司先在第二期導入階段，系統性評估 HCB101 與雷莫蘆單抗及紫杉醇聯合治療的劑量與給藥時程，並接續推進以註冊申請為目標的第三期臨床試驗。再加上HCB101 已取得胃癌孤兒藥資格，公司將能以更清楚的策略框架，嚴謹推進以未來申請上市為目標的臨床開發。」
作為優化策略的一部分，漢康生技計畫持續評估HCB101 的安全性、藥物動力學、藥效學及受體佔據率，同時也將評估其與雷莫蘆單抗與紫杉醇治療方案時的臨床可執行性，包括紫杉醇劑量調整對整體治療方案的影響，以符合 FDA 回饋。公司認為，這對於二線胃癌／胃食管結合部癌中更嚴謹地選定後續治療方案。
漢康生技計畫將 FDA 的回饋納入 HCB101 後續開發，包括劑量／給藥時程探索之試驗計畫書優化、二b期導入階段劑量優化、安全性特徵確認，以及未來臨床研究申請所需之第二／三期主試驗計畫統計架構。
關於HCB101
HCB101是漢康生技基於FBDB™平台開發、經AI輔助設計與結構工程優化的SIRPα–IgG4 Fc融合蛋白，旨在選擇性阻斷CD47–SIRPα訊號傳遞，同時降低與紅血球結合。透過鎖定CD47「別吃我」訊號，HCB101設計上可恢復巨噬細胞介導的吞噬作用、增強抗原呈現，並支持先天免疫至後天免疫的活化。
HCB101的藥理特性與耐受性設計，旨在支持重複給藥，並可望整合於既有癌症治療方案中，包括具腫瘤調理作用的抗體、化療型治療方案，以及免疫檢查點抑制劑。HCB101正作為一項差異化先天免疫檢查點骨架療法，於多種實體瘤適應症中進行開發。
關於漢康-KY
英屬開曼群島商漢康生技股份有限公司（以下簡稱“漢康-KY”，股票代碼：7827）成立於2020年，由具豐富國際藥物開發與運營經驗的劉世高博士創辦。公司專注於腫瘤免疫藥物研發，透過自主建立的核心「FBDB多功能融合蛋白技術平台」開發出8+種創新蛋白生物藥，具有廣譜抗癌潛力，可抑制多種實體瘤及血液腫瘤，並持續取得多項專利。其中HCB101與HCB301已進入臨床試驗階段，而HCB101在2025年6月更完成首項國際授權，總授權金達2.02億美元。漢康-KY的策略是以多功能生物藥克服現行採取免疫療法與化療並行的高失敗率，同時藉由啟動先天性免疫和適應性免疫體系以摧毀腫瘤，致力提供高效且可負擔的新一代腫瘤免疫治療方案，解決未滿足的醫療需求。
聲明
本新聞稿及同時發佈之相關資訊內含有預測性敘述；其內容乃根據既有之風險及可能的不確定性進行判斷及預測，包括：市場因素與其他非漢康-KY（以下簡稱本公司）所能掌控之原因。這些預測性敘述是基於現況的預測和評估，除非基於法律的要求，本公司不負日後更新之責。