專注於免疫腫瘤學創新生物藥開發的漢康-KY（7827）6月30日宣布，與上海復宏漢霖生物技術股份有限公司（以下簡稱上海復宏漢霖）完成區域獨家授權合作協議，協議內容包括簽約金1,000 萬美元，後續依有關里程碑達成情況收取合計不超過1.92 億美元里程金，以上合計最高可達2.02億美元，包括開發、法規與商業相關進展，授權範圍涵蓋中國大陸、香港、澳門、東南亞特定國家、以及MENA特定國家等市場。一旦完成，將為漢康抗癌腫瘤新藥發展再創下一項里程碑。
HCB101為一款以漢康-KY自主開發平台FBDB™（Fc-Based Designer Biologics）打造的多功能融合蛋白生物藥，能精準活化巨噬細胞吞噬癌細胞，以降低對正常血球影響的可能性，優化血液耐受性表現。目前該藥已進入二期臨床試驗（2a），針對頭頸癌、非何杰金氏淋巴瘤（NHL）、實體瘤與血液瘤等進行臨床評估。
據了解，這次授權的對象是上海復宏漢霖，於香港上市（18A），目前已經有六項藥品上市銷售，乃一臨床實驗執行與銷售均備的國際化生物製藥公司。去年淨利潤8.205億人民幣。此次HCB101的區域授權花費由復宏漢霖支出，可以負責開發、生產與銷售。如果未來藥品通過法規審查並順利上市，漢康將依合約收取6%到12%的銷售分潤（Royalty），分潤比例會根據實際銷售額（從2億到5億美元不等）調整。同時，漢康保留對這項藥物的關鍵專利與製程技術的主導權。
根據美國調查研究機構BCC Research，全球免疫腫瘤市場在新療法的推進與癌症病患的增加，預計2029 年達 2,472 億美元，預測期內的複合年成長率（CAGR）為 11.4%，其中免疫療法持續成長，為未來市場滲透提供良好基礎。
回顧台灣2024年新藥國際授權紀錄共完成9件，已揭露金額約3.1億美元，新藥公司包含合一生技、國邑藥品、藥華醫藥與華安醫學。漢康生技董事長兼執行長劉世高博士表示，該授權順利簽約，標誌著台灣創新藥走向全球市場取得又一關鍵進展，也是公司邁向國際市場的重要進展，期望未來進一步拓展全球布局，推動創新藥品開發及病患福祉。
HanchorBio and Henlius Sign Major Licensing Deal for HCB101 to Expand Global Immuno-Oncology Reach
[TAIPEI, SHANGHAI, and SAN FRANCISCO, July 1, 2025] – HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announces the signing of a major out-licensing agreement with Shanghai Henlius Biotech, Inc. (hereafter “Henlius”). The deal grants Henlius exclusive development and commercialization rights to HCB101 across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA).
Under the terms of the agreement, HanchorBio will receive an upfront payment of USD 10 million, with additional payments tied to development and regulatory milestones of up to USD 192 million. Henlius will also pay tiered royalties and assume full responsibility for development, manufacturing, and commercialization in the licensed territories. HanchorBio retains all rights outside the licensed regions.
HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB™) platform. It is designed to selectively block the CD47 “don’t eat me” signal and activate macrophage-mediated anti-tumor immunity. Compared to earlier CD47-targeted agents, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated in over 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics. Its binding affinity to CD47 is 100-fold higher than that of wild-type SIRPα-Fc fusions, and its signal-blocking potency exceeds 1,000-fold that of earlier versions.
In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile, high CD47 receptor occupancy (saturating RO levels across multiple doses), and early signs of anti-tumor activity. Two patients achieved confirmed partial responses (PRs): one with head and neck squamous cell carcinoma and another with marginal zone lymphoma confirmed by both PET imaging and CT, as reported at ASCO 2025. Both tumors continued to shrink with ongoing weekly dosing. Additionally, six patients achieved stable disease at low to mid dose levels, including one ovarian cancer patient who maintained disease control for over 40 weeks.
Following regulatory clearance from the U.S. FDA, China’s NMPA, and Taiwan’s TFDA, HCB101 has advanced into multi-regional Phase 2 trials in patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers.
“This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio’s scientific strength and global partnering strategy,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “It also marks a critical milestone for HanchorBio’s biopharmaceutical innovation as we pursue our mission to deliver globally accessible, next-generation cancer immunotherapies, and as Taiwan continues to gain global recognition.”
As HanchorBio actively fundraises, interested parties may contact: [email protected]
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWO), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite cancer therapies. Committed to reactivating the immune system to fight diseases, 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 making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com
About Henlius.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company’s launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.