HanchorBio Secures Japanese Patent for Engineered SIRPα-IgG4 Fusion Protein HCB101
Patent Approval Strengthens Global Intellectual Property Position and Supports International Licensing Strategy
HanchorBio today announced that the Japan Patent Office (JPO) had granted Japanese Patent No. 7795041 covering engineered SIRPα variants and their therapeutic use, providing intellectual property protection for HCB101, the company’s differentiated SIRPα-IgG4 Fc fusion protein targeting the CD47-SIRPα innate immune checkpoint. The granted patent, titled “ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF” (Engineered SIRPα Variants and Methods of Use Thereof), reinforces HanchorBio’s intellectual property position in one of the world’s most rigorous and strategically important pharmaceutical jurisdictions.
The issuance of this patent reflects recognition of the novelty and inventiveness of HCB101 under Japan’s patent examination standards and supports the company’s broader strategy to build a globally defensible intellectual property portfolio for its innate immune checkpoint programs.
HCB101: A Differentiated Approach to Innate Immune Checkpoint Modulation
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform. The molecule is designed to selectively block the CD47–SIRPα innate immune checkpoint while addressing key limitations observed with earlier CD47-directed approaches, including dose-limiting hematologic toxicity and restricted combination potential.
By incorporating engineered SIRPα variants that reduce binding to red blood cells and platelets while maintaining functional blockade of tumor-associated CD47, HCB101 is intended to support sustained dosing and compatibility with established oncology regimens. The granted Japanese patent covers core engineered features of these SIRPα variants and their therapeutic use, reinforcing long-term differentiation and combination flexibility across solid tumor indications.
Strategy Importance of Japan
Japan represents a strategically important jurisdiction for HanchorBio, given its rigorous patent standards, a globally aligned regulatory framework, and an active biopharmaceutical partnering environment. Patent protection in Japan provides a strong foundation for future clinical development, regional collaborators, and potential commercialization, while supporting ongoing and future licensing discussions with global and Japanese pharmaceutical companies.
Japan has established a mature precision oncology ecosystem in advanced gastric cancer, supported by regulatory approvals across multiple therapeutic classes, including HER2-targeted therapies, anti-angiogenic agents, Claudin 18.2–targeted therapies, tumor-agnostic targeted agents, and immune checkpoint inhibitors. The breadth of approved treatment modalities reflects both high clinical demand and a regulatory environment receptive to innovation, and underscores the importance of agents designed for broad combination compatibility.
Against this backdrop, HCB101 is being advanced in a multinational, multicenter Phase 2a clinical trial, with gastric cancer representing one of the most actively enrolling disease areas. HCB101 was engineered to integrate with established gastric cancer treatment regimens, enabling evaluation across multiple therapeutic approaches within contemporary clinical practice. This positioning supports continued clinical development in Japan and reinforces the relevance of the granted patent as the program progresses.
Clinical Development Progress
HCB101 is currently being evaluated in a multinational, multicenter Phase 2a clinical trial across multiple solid tumor indications. Gastric cancer cohorts, including first-line and second-line settings, represent some of the most actively enrolling populations in the study. Preliminary antitumor activity observed in second-line gastric cancer combination cohorts compares favorably with historical benchmarks; these findings remain investigational and are being evaluated as enrollment and follow-up progress.
Advancing a Global Intellectual Patent Strategy
Following the Japanese patent grant, HanchorBio will continue to advance its intellectual property strategy across Europe, Mainland China, Taiwan, and other key markets, with the goal of establishing a comprehensive global intellectual property protection for HCB101 and related platform technologies.
This approach is intended to protect core innovations while enhancing strategic flexibility and value creation in future international licensing, co-development, and commercialization opportunities.
漢康生技創新 SIRPα/CD47 融合蛋白生物藥 HCB101 獲日本專利核准
強化亞洲關鍵市場布局，奠定國際授權與合作優勢
漢康生技自主研發之創新免疫腫瘤藥物 SIRPα/CD47 融合蛋白 HCB101，近日正式取得日本特許廳 (JPO) 核准，專利名稱為「ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF」（經工程改造之 SIRPα 變體及其使用方法），專利證號7795041。
此次日本專利的核准，代表 HCB101 的核心技術在嚴謹的日本專利審查體系下，獲得對其新穎性與專利價值的高度肯定，也顯示漢康生技在免疫腫瘤領域的創新研發成果，正加速取得國際主要醫藥市場的認可。
HCB101 作用機制與專利關鍵：同類最優 (Best-in-Class) 的融合蛋白設計
HCB101為漢康生技運用自有 FBDB™ (Fc-BaBsed Designer Biologics) 技術平台所開發的 SIRPα/CD47 融合蛋白創新藥，其設計目的在於精準調控免疫系統中的訊號，重新啟動免疫細胞對腫瘤的辨識與清除能力。
腫瘤細胞常在表面大量表現CD47，就像對免疫細胞（如巨噬細胞）掛上一張「不要吃我」的通行證，讓巨噬細胞誤以為它們是正常細胞，這個向免疫系統發出的「免疫逃脫」訊號，使巨噬細胞無法有效吞噬癌細胞。
HCB101 透過工程改造的 SIRPα 變體，能以更高的親合力與功能效力，精準結合腫瘤細胞表面的 CD47，有效恢復免疫細胞對癌細胞的清除反應。
在分子設計上，HCB101 採用 engineered variant（工程改造變體）策略，針對 SIRPα 蛋白中特定關鍵位點進行創新性突變設計，這些結構變異為既有技術中未曾揭露或主張的區域。此一創新設計，不僅提升藥物效力，也顯著降低傳統 CD47 抗體療法常見的血液毒性風險。
為何布局日本專利：市場策略與研發進展高度契合
漢康生技此次成功取得日本專利，與公司整體研發進度與市場策略高度契合。
日本是國際最早積極推動精準醫療的國家之一，在新藥審查與上市速度上，與歐美主要市場接軌，能快速將新藥導入臨床，為患者提供更多元的治療選擇。
截至目前，日本厚生勞動省已核准多項用於晚期胃癌治療的創新藥物，涵蓋不同作用機制與治療策略，包括 HER2 標靶藥物（如Herceptin, Enhertu）、VEGFR抑制劑（如Cyramza）、Claudin 18.2 標靶藥物（如Vyloy）、不限癌種的 NTRK 抑制劑（如Vitrakvi, Rozlytrek），以及 免疫治療藥物（如Opdivo, Keytruda）。
對漢康生技而言，日本不僅是重要的藥品市場，更是高度重視臨床科學與創新價值的關鍵國家。取得日本專利，意味著 HCB101 在未來臨床開發、在地合作與商業化布局上，具備明確的智財保障，有助於加速與日本藥廠的合作洽談。
此外，日本市場亦具有以下戰略意義：
- 高齡化與癌症治療需求高度集中：日本為全球高齡化程度最高的國家之一，日本癌症免疫療法市場規模不斷成長，免疫療法因延長存活期與較低副作用而受到重視，特別適合高齡患者使用。
- 日本藥品審查體系成熟：與國際標準一致，強調品質、安全與療效，近年更加速創新療法的上市審查，為患者提供更多新選擇。
- 亞洲市場具高度指標性：日本在專利審查與臨床標準上的嚴謹度，對亞洲其他國家具有重要示範與參考價值
- 創新藥物合作環境成熟：日本藥廠長期積極透過授權與共同開發，引進具全球潛力的創新生物藥，形成穩健的市場導入通路。
同時，根據KD Market Insights資料顯示，日本是全球胃癌發病率最高的國家之一，且日本國立癌研究中心（国立がん研究センター）預測，2025年日本胃癌新診斷病例數接近12萬例，因為癌死亡的人數亦高達近4萬人。長期以來，日本在胃癌的診斷、治療與新藥導入上，已建立完善的臨床體系，並形成高度成熟的醫療市場。
在日本胃癌高度盛行、臨床需求集中的背景下，HCB101 正於多國多中心臨床二期（2a）試驗中穩健推進，其中一線及二線胃癌為收案速度最快的適應症之一。其在胃癌二線治療中所展現的臨床成果尤具指標性，聯合療法的客觀緩解率（ORR）達 80%，明顯優於歷史標準療法約 26.5%，突顯出HCB101在胃癌治療市場成為新一代關鍵療法的潛力。
全球專利佈局持續推進 強化國際合作與授權競爭力
隨著日本專利正式核准，漢康生技將持續推進歐洲、中國大陸、台灣及其他亞洲重點國家的專利布局，建立完整且具區域深度的全球智財防護網。
透過涵蓋主要醫藥市場的專利策略，漢康生技不僅可有效保護核心技術，更能在未來國際授權、共同開發與商業化談判中，掌握更大的主動權與價值轉換空間。
此項日本專利的取得，除為漢康生技建立堅實的智財防護，也再度提升其國際授權、共同開發與策略合作談判中的價值。