HanchorBio Highlights Clinical, Pipeline, and Global Growth Strategy
HCB101 clinical validation anchors FBDB™ platform expansion, global partnering, and international capital markets strategy
[Taipei, Shanghai, San Francisco | September 8, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today highlighted its clinical development, pipeline expansion, and global growth strategy following a presentation at the “2026 Q3 Global Outlook Autumn Investment Forum” hosted by President Securities at Grand Hyatt Taipei.
HanchorBio Chief Financial Officer Mu-Tseng Tseng presented the Company’s strategy to build on the clinical validation of HCB101, expand its proprietary FBDB™ multifunctional biologics platform, advance global partnering opportunities, and broaden the Company’s engagement with international capital markets.
Global Biotechnology Market Rebounds as Capital Increasingly Focuses on Clinical Validation and Partnership Value
Global biotechnology markets have strengthened over the past year, while licensing and strategic partnership activity has remained active. According to Goldman Sachs research, as of the end of July 2026, the NYSE Arca Biotechnology Index and Nasdaq Biotechnology Index had generated approximately 50% and 46% returns, respectively, over the preceding 12 months. Separately, data from J.P. Morgan and DealForma indicated that global biopharmaceutical licensing transactions reached approximately US$82.7 billion in the first quarter of 2026.
Tseng noted that investor and strategic interest is increasingly concentrated on companies with differentiated science, human clinical validation, clear development pathways, and global partnering potential.
HCB101 Anchors Clinical Development
HCB101, HanchorBio’s proprietary SIRPα-Fc fusion protein targeting the SIRPα-CD47 immune checkpoint, serves as the Company’s lead clinical anchor and is being developed as a potential macrophage-directed immunotherapy backbone for combination treatment.
Second-line gastric/gastroesophageal junction (GC/GEJ) cancer remains a key development priority. In previously disclosed early clinical data, HCB101 combination therapy at clinically relevant dose levels demonstrated an 80% objective response rate (ORR) and 100% disease control rate (DCR) in second-line GC/GEJ cancer.
HanchorBio is also evaluating HCB101 across colorectal cancer, head and neck cancer and other tumor types as it seeks to establish the broader potential of macrophage-directed immunotherapy across multiple standard-of-care combination strategies.
“Clinical progress remains our most important value driver,” said Tseng. “Our strategy is to establish HCB101 as a strong clinical anchor, expand the biology through our FBDB™ platform, and create multiple paths for value through internal development and global partnerships.”
According to IQVIA market analysis, the global market associated with second-line GC/GEJ cancer and second-line colorectal cancer are projected to reach approximately US$709 million and US$3.5 billion, respectively, by 2036, highlighting the potential opportunity as HCB101 development expands across indications.
Expanding from Clinical Anchor to Platform
Clinical and translational learnings from HCB101 are informing the continued expansion of HanchorBio’s FBDB™ platform.
The Company is advancing a portfolio that includes HCB301, a trispecific SIRPα/PD-L1/TGF-β fusion protein; HCB303, a next-generation trispecific program integrating SIRPα/CD47, PD-L1/PD-1 and TIGIT/PVR biology; and HCB206, a CD20 × SIRPα program extending macrophage-directed biology beyond oncology into immune-mediated diseases.
Together, these programs reflect HanchorBio’s strategy of moving from a single clinical anchor toward a broader portfolio of multifunctional biologics designed to coordinate innate and adaptive immunity.
Global Partnering and Capital Markets Strategy
HanchorBio continues to advance business development alongside its internal R&D programs. During the first half of 2026, the Company held face-to-face discussions with more than 20 global pharmaceutical companies regarding HCB101, while additional partnering discussions have continued across HCB301 and HCB206.
Following HanchorBio’s listing on the Taiwan Innovation Board in May 2026, the Company’s Board of Directors also approved a proposal for a potential American Depositary Receipt (ADR) offering, subject to shareholder and regulatory approvals.
The proposed ADR program is intended to broaden HanchorBio’s access to international biotechnology and healthcare investors and strengthen the Company’s connectivity with global capital markets as its clinical pipeline advances.
Focused on the Next 3 to 12 Months
Over the next 3 to 12 months, HanchorBio expects to remain focused on key value-driving milestones across clinical development, pipeline expansion, international licensing, and strategic collaborations.
Building on the clinical foundation established by HCB101, the Company aims to translate clinical validation into broader platform value across oncology and immune-mediated diseases while continuing to expand its global development, partnering and capital markets presence.
About HanchorBio
HanchorBio, Inc. (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. By integrating complementary innate and adaptive immune mechanisms with differentiated biologic architectures, HanchorBio is advancing a pipeline of therapies designed to address treatment resistance in oncology and immune-mediated diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategies, partnering activities, capital markets plans, and future development. Actual results may differ materially from those expressed or implied due to clinical development outcomes, regulatory review decisions, market conditions, and other risks and uncertainties. Except as required by applicable law, HanchorBio undertakes no obligation to update any forward-looking statements.
漢康-KY受邀出席統一證券秋季投資論壇 分享臨床開發、產品布局與全球化策略
聚焦HCB101臨床驗證、FBDB™平台拓展及國際合作，分享公司中長期發展方向
【台北、上海、舊金山，2026年9月8日】－全球臨床階段生技公司漢康-KY（TWSE：7827）表示，公司日前受邀出席統一證券於台北君悅酒店舉辦的「2026 Q3全球展望秋季投資論壇」，由財務長曾木增進行專題演講，分享全球生技產業與資本市場趨勢，以及公司在臨床開發、產品線拓展、國際商務合作與全球資本市場布局上的最新進展。
曾木增指出，目前投資人與策略合作方的關注更集中於具備差異化科學、人體臨床驗證、明確開發路徑及全球合作潛力的公司。漢康-KY目前以HCB101作為核心臨床支點，並持續推進FBDB™多功能生物藥平台的後續產品開發，透過內部研發與外部合作雙軌並進，建立更完整的中長期產品及全球發展布局。
全球生技市場回暖 資金更聚焦臨床驗證與合作價值
根據高盛集團研究，截至2026年7月底，NYSE Arca Biotechnology Index與Nasdaq Biotechnology Index過去12個月報酬率分別約達50%及46%，顯示全球生技類股投資情緒明顯回升。另一方面，J.P. Morgan與DealForma相關資料顯示，2026年第一季全球生物製藥授權交易總額達約827億美元，反映大型藥廠持續透過外部創新補充產品線，並帶動授權、共同開發活動升溫。
曾木增指出，這一波資金回流更聚焦於已具有臨床數據、差異化作用機制、國際授權潛力及中長期成長動能的公司。對臨床階段生技公司而言，能否持續累積人體數據、建立清楚的產品開發路徑，並將科學創新轉化為可驗證的臨床與商業價值，將成為下一階段市場重新評價的重要基礎。
HCB101建立臨床支點 驗證巨噬細胞導向免疫治療策略
目前漢康-KY以HCB101作為核心臨床支點。HCB101為公司自主開發、鎖定SIRPα-CD47免疫檢查點的融合蛋白候選藥物，透過阻斷腫瘤細胞所產生的CD47「別吃我」訊號，恢復巨噬細胞辨識及吞噬腫瘤細胞的能力，並進一步促進腫瘤抗原處理與呈現、啟動後續T細胞免疫反應，形成由先天免疫延伸至適應性免疫的治療策略。
公司目前以二線胃癌／胃食道交界癌作為 HCB101 主要臨床開發重點，並持續向結直腸癌、頭頸癌等適應症拓展。依公司先前揭露的早期臨床數據，HCB101 於二線胃癌／胃食道交界癌臨床相關劑量聯合治療中觀察到 80% 的客觀緩解率（ORR）及 100% 的疾病控制率（DCR）。
此外，台灣研究者發起之結直腸癌探索性研究亦提供持久性臨床訊號，在低劑量HCB101搭配貝伐珠單抗（bevacizumab）及化療的3名患者中均達疾病控制（SD）。上述早期數據仍持續追蹤中，進一步支持HCB101作為巨噬細胞導向免疫治療骨幹，與不同標準治療進行聯合開發的潛力。
漢康-KY表示，HCB101的開發策略並非侷限於單一癌種，而是以目前最具臨床開發潛力的適應症建立支點，再透過不同腫瘤類型驗證其可擴展性。根據 IQVIA 市場分析，至 2036 年，全球二線胃癌／胃食道交界癌與二線結直腸癌相關市場規模預估將分別達約 7.09 億美元及 35 億美元，顯示 HCB101 隨適應症拓展所具備的潛在市場機會。
從單一產品走向平台 HCB301、HCB303與HCB206持續延伸
HCB101的意義亦不僅限於單一候選藥物。隨著其逐步建立人體臨床驗證，公司正以此為基礎，持續推進HCB301、HCB303及HCB206等後續產品，將巨噬細胞導向免疫從單一臨床資產延伸為更完整的產品平台。
其中，HCB301及HCB303均為三功能融合蛋白生物藥。HCB301為整合 SIRPα、PD-L1 與 TGF-β 的三功能融合蛋白生物藥，著重於同時恢復巨噬細胞功能、活化T細胞並改善免疫抑制性腫瘤微環境；HCB303則進一步整合SIRPα/CD47、PD-L1/PD-1與TIGIT/PVR生物學機制，透過巨噬細胞、T細胞與NK細胞等多重免疫作用，探索適應性抗藥腫瘤的治療機會。
雙功能融合蛋白HCB206則將平台由腫瘤領域進一步拓展至免疫介導疾病。HCB206採CD20 × SIRPα設計，鎖定與致病性B細胞相關的疾病生物學，藉由巨噬細胞導向的細胞清除機制，探索較深度且持久的B細胞清除策略。透過上述產品布局，公司逐步形成「臨床支點、平台拓展、策略性產品組合」的研發架構。
內部研發與外部合作雙軌推進
除內部產品線持續推進外，漢康-KY亦同步拓展全球商務合作。2026 年上半年，公司已與 20 家以上全球藥廠就 HCB101 進行面對面交流，HCB301 與 HCB206 亦持續推進相關合作洽談。公司將持續以臨床進展為核心價值驅動因素，並透過內部研發與全球合作創造多元發展機會。
完成台灣上市後 推進ADR規劃接軌全球資本市場
資本市場方面，漢康於今年 5 月完成台灣創新板掛牌上市後，董事會已通過現金增資發行普通股參與發行美國存託憑證（ADR）案，目前仍待股東會及主管機關核准。若後續順利推進，預期將有助公司拓展與國際生技及醫療專業投資人的連結，並進一步強化公司與全球資本市場的接軌。
聚焦未來3至12個月關鍵里程碑
漢康-KY表示，未來3至12個月將持續聚焦HCB101及其他產品臨床進展、國際授權與策略合作，以及新增產品線等重要里程碑。公司將以HCB101所建立的臨床驗證為核心，持續深化FBDB™平台於腫瘤及免疫介導疾病領域的產品布局，同時透過國際合作及全球資本市場接軌，逐步將單一產品的臨床價值轉化為更完整的平台與企業長期成長動能。
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，專注透過自主開發的 FBDB™ 多功能生物藥平台，開發用於癌症與免疫介導疾病的下一代生物製劑。透過整合互補的先天性與適應性免疫機制及差異化生物藥設計，漢康生技持續推進產品管線，以因應腫瘤及免疫介導疾病中的治療抗藥性。
前瞻性聲明
本新聞稿包含有關漢康生技臨床開發計畫、候選產品、法規策略、合作活動、資本市場規劃及未來發展之前瞻性陳述。由於臨床開發結果、法規審查決策、市場環境及其他各項風險與不確定因素，實際結果可能與本新聞稿中明示或暗示之前瞻性陳述存在重大差異。除適用法律另有規定外，漢康生技不承擔更新任何前瞻性陳述之義務。