HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer
First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status in Gastric Cancer
HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.
This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need.
HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.
“Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101’s profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline.”
Gastric cancer is a rare disease in the United States, with prevalence well below the FDA’s statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity.
HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule’s differentiated design.
Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, “The FDA’s decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101’s development. HCB101’s IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need.”
Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States.
HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.
HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.
Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to reshape the landscape of cancer therapies. Committed to reactivating the immune system to fight disease, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs.
漢康開發中新藥 HCB101 獲美國 FDA 授予用於胃癌之孤兒藥資格認定
漢康主力新藥HCB101獲美國FDA授予治療胃腺癌的孤兒藥資格認定（Orphan Drug Designation, ODD）。這項認定不僅突顯HCB101在未被滿足醫療需求的重大潛力，更能取得包含稅務優惠、藥證申請費用減免、藥證審查加速及最重要的7年市場獨賣期等多項政策支持。
胃腺癌（Gastric Adenocarcinoma）是最常見的胃癌類型，主要是胃內壁分泌黏液和消化液的腺體細胞異常增生所致，在全球癌症發病率排名第五、全球癌症死因排名第四，屬於一種高度致命的惡性腫瘤。
胃癌以東亞地區的發病率最高，包括中國大陸、台灣、日本及韓國等，主要與飲食習慣、幽門螺旋桿菌感染、生活方式及家族遺傳背景等有關。
美國胃腺癌人數雖然不如亞洲國家（如東亞）發生率高，但仍高居十大癌症死因之一，估計目前胃癌的全病程（指涵蓋確診、治療到復發、轉移或安寧照護等階段）患者約14萬人。此外，每年約有11,000名病患是以晚期、不可切除或轉移性疾病的狀態確診，根據美國癌症統計數據（SEER Cancer Stat Facts），該族群也會是接受全身性治療的目標群體，因此，美國胃癌患者數符合美國孤兒藥法案（Orphan Drug Act）中對罕見疾病人數低於20萬人的法定門檻。
漢康的HCB101是運用自主核心FBDB技術平台所開發的創新融合蛋白藥物，屬於廣譜抗癌新藥，目前持續開展多國多中心2a期臨床試驗，適應症涵蓋針對一線及二線（晚期）胃癌、一線三陰性乳癌、二線頭頸癌、結直腸癌等。其中，聯合複合療法（HCB101合併雷莫西尤單抗+化療藥紫杉醇）在二線胃癌的初步數據表現優異，不僅展現良好耐受性與安全性，客觀反應率（ORR）近達八成，明顯優於現行SOC標準療法（雷莫西尤單抗+化療藥紫杉醇）歷史數據僅26.5%。
根據市調機構MordorIntelligence的報告顯示，全球胃癌治療市場規模在2025年為59.9億美元，預估至2030年將達到108.6億美元，期間年複合成長率 (CAGR) 達12.63%。
現行晚期胃癌治療仍缺乏良好藥物，多以化療為主、搭配免疫檢查點抑制劑或標靶藥物，以提升存活期，但依目前標準療法的中位整體存活期（OS）僅10～12個月，而HCB101挾結合多重免疫機制的優勢，目標要提供比標準療法更好的總存活率和無惡化存活期（PFS），形成兼具生物學合理性與臨床可操作性的抗腫瘤策略，有機會成為治療二線胃癌的新標竿。