HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit
HCB101 represents the first known U.S. Expanded Access case for a SIRPα Fc fusion protein enabling continued therapy beyond the parent study.
TAIPEI, SHANGHAI, and SAN FRANCISCO — September 9, 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 its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as “safe to proceed”.
The FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company’s Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. Expanded Access, or compassionate use, allows patients with serious or life-threatening diseases to receive investigational therapies outside standard clinical trials when specific regulatory criteria are met. In an individual-patient Expanded Access request, FDA considers the patient’s clinical circumstances, including whether the potential benefit justifies the potential risks and whether those risks are reasonable in the context of the disease.
“For us, this starts with the patient,” said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. “When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered. HCB101 was created to make a meaningful difference, and this milestone reflects the patient-first principle guiding our FBDB™ platform.”
FDA’s determination that HCB101-EA-001 is “safe to proceed” applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy.
“Working within the FDA framework, we translated an individual patient’s need into a practical solution allowing treatment to continue,” said Alvin Luk, Ph.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive Officer (USA) of HanchorBio. “That is where clinical medicine, regulatory science, and drug development properly align.”
A Potential First for the SIRPα-Fc Fusion Protein Class
While Expanded Access pathways have previously been utilized for the anti-CD47 monoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:
Targeted Continuation: Unlike broad population access programs, HCB101-EA-001 was specifically established to extend treatment for an individual patient who determined clinical benefit during a Phase 1 clinical trial.
Novel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to block the CD47-SIRPα “don’t eat me” signal and trigger macrophage-mediated tumor-cell phagocytosis.
Based on publicly available information, HanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a significant precedent as HanchorBio continues to advance the program globally across multiple tumor types and combination strategies.
About HCB101
HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes clinical-stage programs HCB101 and HCB301, next-generation trispecific program HCB303, and additional candidates across oncology and immune-mediated diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding HCB101, including its clinical development, potential therapeutic benefits, regulatory interactions, and the significance of the HCB101-EA-001 Expanded Access protocol. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied.
HCB101 is investigational and has not been approved for commercial use by the U.S. FDA or any other regulatory authority. FDA’s determination that HCB101-EA-001 is “safe to proceed” applies only to this specific Expanded Access protocol and does not constitute approval of HCB101 or a determination of its safety or efficacy for a broader patient population.
HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康生技 HCB101 達成臨床開發里程碑 美FDA 同意單一病人擴大使用（恩慈使用）
HCB101 為目前已知美國首例 SIRPα-Fc 融合蛋白擴大使用案例，支持病人在原臨床試驗之外持續接受治療
【台北、上海、舊金山，2026 年 9 月 9 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之下一代免疫療法，今日宣布，美國食品藥物管理局（FDA）已同意公司 HCB101 單一病人擴大使用方案（Single-Patient Expanded Access Protocol）「可安全進行（safe to proceed）」，FDA 的決定讓一名曾在漢康生技第一期臨床試驗中接受 HCB101 治療，且治療期間獲得臨床受益的病人，在原臨床試驗結束後仍可繼續接受 HCB101 治療。
擴大使用，亦稱恩慈使用（compassionate use），係指罹患嚴重或危及生命疾病的病人，在符合特定法規條件下，得於一般臨床試驗之外接受尚在研發階段的治療。針對單一病人的擴大使用申請，FDA 將評估病人的臨床狀況，包括潛在治療利益是否足以支持其潛在風險，以及在該疾病情境下相關風險是否屬合理範圍。
漢康生技創辦人暨董事長劉世高博士表示：「對我們而言，一切都從病人的需求出發。當病人正從一項研究中療法獲得臨床受益，且可選擇的治療方式有限時，我們相信應審慎評估所有適當途徑，讓病人有機會持續接受治療。HCB101 的開發初衷，就是希望能為病人帶來實質意義，而這項里程碑也體現了我們在推動 FBDB™ 平台時始終堅持的病人優先原則。」
FDA 對 HCB101做出「可安全進行」的決定，僅適用於此單一病人的擴大使用方案，並不代表 HCB101 已獲 FDA 核准，亦不代表 FDA 已對 HCB101 的療效作出認定。
漢康生技集團總裁暨醫療長、美國公司執行長陸英明博士表示：「在 FDA 法規框架下，我們將單一病人的實際需求轉化為可執行的治療延續方案，使病人得以持續接受治療。這正是臨床醫療、法規科學與新藥開發彼此接軌並發揮作用的地方。」
SIRPα-Fc 融合蛋白類別的潛在首例
過去抗 CD47 單株抗體已有透過擴大使用途徑提供治療的案例，但 HCB101在臨床情境及分子結構上均有所不同：
- 針對個別病人延續治療： 不同於針對較廣泛病人族群所設立的擴大使用計畫，此次專為一名在第一期臨床試驗期間獲得臨床受益的病人所設立，以延續其 HCB101 治療。
- 創新作用機制： HCB101 為一款工程化 SIRPα-Fc 融合蛋白，設計用以阻斷 CD47-SIRPα「別吃我」訊號，進而促使巨噬細胞吞噬腫瘤細胞。
根據目前公開資訊，漢康生技認為，HCB101為美國首例公開報導的 SIRPα-Fc 融合蛋白擴大使用案例。隨著漢康生技持續在全球推進 HCB101 於多種腫瘤及不同聯合治療策略的臨床開發，此案例亦為該類療法的後續發展建立重要先例。
關於 HCB101
HCB101 為漢康生技運用專有 FBDB™ 平台開發的研究中工程化 SIRPα–IgG4 Fc 融合蛋白。HCB101 藉由阻斷 CD47–SIRPα 訊號，恢復巨噬細胞介導的抗腫瘤免疫作用，並進一步促進下游新生（de novo）T 細胞活化。
目前 HCB101 正進行單藥治療及聯合治療臨床試驗，涵蓋實體腫瘤與血液惡性腫瘤，並已取得美國 FDA 胃癌孤兒藥資格認定。
關於漢康生技
漢康生技（TWSE：7827）是一家全球臨床階段生技公司，運用自主開發的 FBDB™ 平台，致力於開發癌症及免疫介導疾病的下一代創新生物藥。漢康生技目前產品線包括已進入臨床階段的 HCB101 與 HCB301、下一代三特異性候選藥物 HCB303，以及其他針對癌症與免疫介導疾病的研發候選藥物。
前瞻性聲明
本文稿包含有關 HCB101 的前瞻性聲明，包括其臨床開發、潛在治療效益、法規互動，以及 HCB101擴大使用方案的重要性。相關聲明涉及風險與不確定性，實際結果可能與前瞻性聲明所明示或暗示之內容存在重大差異。
HCB101 目前仍屬研究中新藥，尚未獲美國 FDA 或其他任何主管機關核准上市。FDA 對 HCB101做出「可安全進行」的決定，僅適用於此特定擴大使用方案，並不代表 FDA 已核准 HCB101，亦不構成對 HCB101 於更廣泛病人族群之安全性或療效的認定。
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。