[TAIPEI, SHANGHAI, and SAN FRANCISCO, July 17, 2025] –HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announced that the Taiwan Food and Drug Administration (TFDA) has approved a third investigator-initiated trial (IIT) evaluating HCB101 in combination with zolbetuximab and chemotherapy for the first-line treatment of patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will be conducted at Kaohsiung Medical University Chung-Ho Memorial Hospital under the leadership of Dr. I-Chen Wu and Dr. Li-Tzong Chen, and at China Medical University Hospital, led by Dr. Li Yuan Bai.
This latest TFDA approval follows earlier IIT approvals in colorectal and head and neck cancers. It represents another milestone in HanchorBio’s commitment to advancing novel and potentially efficacious immunotherapy combinations across difficult-to-treat solid tumors with high unmet needs.
“This TFDA approval is particularly meaningful to us, not only because gastric cancer remains a significant challenge in Asia, but because it shows how far we have come in building a platform that blends science with heart,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “It’s especially rewarding to see this trial, along with our other TFDA-approved IITs, being conducted in some of Taiwan’s top research-oriented general hospitals. These studies reflect our broader mission to bring HCB101 to patients across Asia, supported by professional clinical partnerships and the strong momentum from our recent listing on the Emerging Stock Market of the Taipei Exchange. With this gastric cancer trial, we are expanding the potential of HCB101 into another area of unmet medical need, where engineered immune modulation could truly make a difference.”
About the Investigator-Initiated Trial in Advanced Gastric Cancer
The open-label, dose-escalation, and dose-expansion trial (HCB101-IIT-GC-202501) is designed to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination with zolbetuximab and chemotherapy in patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or GEJ adenocarcinoma who have progressed following prior standard therapy.
Patients will receive:
•HCB101 administered intravenously every week,
•Zolbetuximab administered every 3 weeks with 800 mg/m2 on Day 1 of Cycle 1, followed by 600 mg/m2 on Day 22 and in subsequent cycles (Days 1 and 22) in combination with mFOLFOX6,
•Chemotherapy consists of either:
omFOLFOX6: up to 12 cycles of oxaliplatin, leucovorin, and 5-FU every 2 weeks, or
oCAPOX: up to 8 cycles of oxaliplatin plus oral capecitabine every 3 weeks.
The investigator will select the chemotherapy backbone based on the patient’s prior treatment history. Patients who do not progress after 4 cycles of mFOLFOX6 will continue zolbetuximab plus fluoropyrimidine and folinic acid at the investigator’s discretion.
HCB101 + Zolbetuximab + Chemotherapy: Combination Rationale
HCB101 is an engineered SIRPα fusion protein developed through AI-assisted structural modeling and large-scale screening of a phage library containing 108 different SIRPα variants. It is designed to selectively and effectively block the CD47-SIRPα “don’t eat me” signal, enhancing macrophage phagocytosis and adaptive immune priming while maintaining a desirable safety profile. Preclinical data suggest that CD47 blockade can synergize with antibody-based and chemotherapy regimens to enhance inhibition of tumor growth while potentially reducing the hematologic toxicity. Zolbetuximab is a CLDN18.2-targeted monoclonal antibody approved in multiple regions for the treatment of gastric cancer, functioning through both ADCC and CDC mechanisms. Chemotherapy (mFOLFOX6 or CAPOX) provides the cytotoxic backbone to drive antigen release and tumor debulking.
The triplet combination is designed to simultaneously target:
•Innate immune suppression (via CD47 blockade with HCB101),
•Tumor-specific antigen engagement (via CLDN18.2 with zolbetuximab), and
•Tumor burden reduction (via cytotoxic chemotherapy).
This coordinated approach provides a rational strategy to overcome the immunologically “cold” tumor microenvironment seen in CLDN18.2-positive gastric cancer and achieve stronger, more durable anti-tumor responses.
About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a potential best-in-class Fc-fusion SIRPα variant designed to optimize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 exhibits selective tumor engagement with low binding to red blood cells (RBCs), thereby reducing the risk of anemia and thrombocytopenia commonly associated with other CD47-targeting agents.
Key Differentiators of HCB101:
•Enhanced safety profile: Reduced RBC depletion compared to traditional CD47-targeting agents.
•Synergistic immune activation: Strongly enhanced ADCP, bridging innate and adaptive immune responses to drive durable anti-tumor immunity.
•Broad tumor applicability: Demonstrated activity in over 80 CDX and PDX preclinical models across multiple solid tumors and hematological malignancies.
•Early signs of clinical efficacy: At the 2025 ASCO Annual Meeting, it was reported that HCB101 monotherapy demonstrated confirmed partial responses in two patients (one with HNSCC and one with marginal zone lymphoma) and stable disease in six additional heavily pretreated patients, including prolonged disease control exceeding 40 weeks in a patient with ovarian cancer. These findings provide early clinical evidence of long-lasting antitumor activity.
HCB101 is currently being evaluated in multiple clinical trials, including:
•HCB101-101 (NCT05892718): A Phase 1 open-label, multi-regional, multi-center, dose-finding, first-in-human monotherapy trial of HCB101 in advanced solid tumors or relapsed and refractory non-Hodgkin lymphomas.
•HCB101-201 (NCT06771622): A Phase 1b/2a open-label, multi-regional, multi-center trial of HCB101 in combination with standard-of-care therapies in multiple advanced solid tumors.
•HCB101-IIT-CRC-202401: An open-label, dose-escalation, and dose-expansion investigator-initiated trial of HCB101 in combination with cetuximab or bevacizumab and chemotherapy regimens in RAS/BRAF wild-type advanced or metastatic colorectal cancer.
•HCB101-IIT-HNSCC-202401: A non-randomized, open-label, dose-escalation, and dose-expansion investigator-initiated trial of HCB101 in combination with pembrolizumab in patients with cisplatin-refractory, recurrent or metastatic head and neck squamous cell carcinoma (SirH&N Trial).
•HCB101-IIT-GC-202501: An open-label study to evaluate safety, tolerability, and antitumor activity of HCB101 in combination with multiple agents in subjects with advanced gastric or gastro-esophageal (GEJ) adenocarcinoma.
漢康生技再獲 TFDA 核准：HCB101 聯合療法拓展至晚期胃癌
【台北、上海與舊金山，2025 年 7 月 17 日】— 全球臨床階段生技公司漢康生技（HanchorBio Inc., 股票代號：7827.TWO），致力於開發創新免疫療法用於癌症與自體免疫疾病，今日宣布：台灣衛福部食藥署（TFDA）已核准一項由研究者發起的第三項臨床試驗（IIT），評估 HCB101 聯合 zolbetuximab 與化療，用於 HER2 陰性、CLDN18.2 陽性之晚期或轉移性胃癌與胃食管交界處（GEJ）腺癌患者的一線治療。此試驗將於高雄醫學大學附設中和紀念醫院（主持醫師：吳宜珍醫師、陳立宗醫師）與中國醫藥大學附設醫院（主持醫師：白禮源醫師）進行。
這項最新核准延續了先前於結直腸癌與頭頸癌的 IIT 核准，象徵漢康生技在開發創新且具潛力的免疫聯合療法，用以治療高度未滿足醫療需求的困難腫瘤領域上，再邁出一大步。
漢康生技創辦人兼董事長劉世高博士表示：「這項 TFDA 的核准對我們意義重大，不僅因為胃癌在亞洲仍是一項重大挑戰，更因為它展現我們結合科學與人本關懷所建構平台的成就。這項試驗與其他 TFDA 核准的研究者試驗皆於台灣頂尖的醫學中心展開，這反映出我們的使命──透過專業臨床合作關係及近期興櫃掛牌並驅的強大動能，將 HCB101 推展至亞洲更多患者之中。本次胃癌試驗讓我們得以擴展 HCB101 的潛力，至另一個極需新療法的領域，期望基因工程免疫調控在此能帶來實質改變。」
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關於胃癌研究者發起試驗（IIT）
本開放標籤、劑量爬升與擴展試驗（HCB101-IIT-GC-202501），旨在評估 HCB101 聯合 zolbetuximab 與化療治療 HER2 陰性、CLDN18.2 陽性晚期或轉移性胃癌／GEJ 腺癌患者的安全性、耐受性及初步療效。
患者將接受下列治療：
•HCB101：每週靜脈注射。
•Zolbetuximab：每 3 週給藥，第一循環第 1 天為 800 mg/m²，其後在第 22 天及後續每循環第 1 與第 22 天為 600 mg/m²，並聯合化療。
•化療方案（由研究者依據病患病史選擇）：
omFOLFOX6：最多 12 個循環，包含奧沙利鉑、葉酸與 5-FU，每 2 週一次。
oCAPOX：最多 8 個循環，包含奧沙利鉑與口服 capecitabine，每 3 週一次。
若病患經 4 個循環 mFOLFOX6 未出現疾病進展，則研究者可酌情持續使用 zolbetuximab 聯合氟尿嘧啶與葉酸。
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聯合治療組合的作用機制
HCB101
為經由 AI 結構建模與含有 1億種以上的 SIRPα 噬菌體庫篩選所開發之改構的 SIRPα 融合蛋白。其主要機制為阻斷 CD47-SIRPα「別吃我」訊號，增強巨噬細胞吞噬與激活後續的適應性免疫，並維持良好安全性。前臨床數據顯示 CD47 阻斷能與抗體或化療產生協同抑制腫瘤增長，且可望降低血液毒性。
Zolbetuximab
為針對 CLDN18.2 的單株抗體，已於多國獲准治療胃癌，透過 ADCC 與 CDC 機制發揮作用。
化療（mFOLFOX6 或 CAPOX）
作為細胞毒性基礎，協助抗原釋放與腫瘤體積減少。
此三重聯合療法能同時針對：
•先天免疫抑制（HCB101 阻斷 CD47）、
•腫瘤特異性抗原（zolbetuximab 攻擊 CLDN18.2）、
•腫瘤負荷降低（化療殺死腫瘤細胞）。
此協同策略旨在克服 CLDN18.2 陽性胃癌中「冷」的腫瘤微環境 (“cold” tumor microenvironment) ，期望產生更強與持久的抗腫瘤反應。
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關於 HCB101：差異化 CD47-SIRPα 阻斷劑
HCB101 為潛在同類最佳（best-in-class）Fc融合型 SIRPα 變異蛋白，具備啟動免疫力並同時降低血液毒性的特性。不同於傳統 CD47 單抗，HCB101 對紅血球的結合度低，有助於減少貧血與血小板減少等副作用。
HCB101 特色：
•安全性提升：相比傳統 CD47 抗體，對紅血球影響低。
•免疫活化強效：強化吞噬作用，橋接先天與後天免疫。
•廣泛腫瘤應用：超過 80 種實體瘤與血癌模型中表現活性。
•早期療效訊號：2025 年 ASCO 年會報告顯示，HCB101 單藥於一名頭頸癌與一名邊緣帶淋巴瘤患者中產生部分顯著緩解（PR），另有六名治療患者出現病情穩定 (SD)，含一例卵巢癌病情穩定超過 40 週。
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HCB101 相關臨床試驗
•HCB101-101（NCT05892718）：HCB101 單藥於晚期實體瘤或復發難治非霍奇金淋巴瘤之第一期劑量探索。
•HCB101-201（NCT06771622）：與標準療法聯合治療多種晚期實體瘤之 1b/2a 期臨床試驗。
•HCB101-IIT-CRC-202401：聯合 cetuximab 或 bevacizumab 與化療用於晚期大腸直腸癌之 IIT。
•HCB101-IIT-HNSCC-202401：聯合 pembrolizumab 用於頭頸癌患者（SirH&N 試驗）。
•HCB101-IIT-GC-202501：針對晚期胃癌／GEJ 腺癌患者，評估 HCB101 聯合多重藥物之安全性與療效的開放性研究。