NEWS

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.

HCB303 is a novel fusion protein designed to target multiple major immunosuppressive pathways, including PD-L1/PD-1, SIRPα/CD47, and others. By engaging both innate and adaptive immunity, it aims to enhance immune activation within the tumor microenvironment, driving T cell activation, NK cell cytotoxicity, and macrophage phagocytosis. HCB303 is currently in process development, with an IND submission planned by 2026, marking a key milestone in HanchorBio’s multi-target immunotherapy strategy to deliver breakthrough options for patients with refractory cancers.

HCB101臨床研究目前的主要發現包括：
在遞增的不同劑量群組中具有良好的安全性和耐受性
抗腫瘤初步療效數據包括：
6 位受試者（低劑量隊列）出現疾病穩定 （Stable Disease, SD），其中包括1位接受過多線治療的卵巢癌患者，在1.28 mg/kg劑量組中，疾病穩定已超過32周。
2位受試者出現部分緩解（Partial Response, PR）

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 – June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announced that interim clinical data from its lead immunotherapy product, HCB101, has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4 in Chicago, Illinois.

The accepted abstract (#2584: Phase 1 trial of HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, in subjects with advanced cancers) highlights emerging data from the ongoing Phase 1 dose-escalation trial (NCT05892718) of HCB101, a differentiated SIRPα-Fc fusion protein rationally engineered to enhance phagocytosis and innate immune activation, without the hematologic toxicity that has hindered earlier CD47-targeting therapies. HCB101 is being evaluated as monotherapy in patients with advanced solid tumors or relapsed/refractory (R/R) non-Hodgkin lymphomas (NHLs). The poster presentation is scheduled for June 2, 2025, during the ASCO Immunotherapy session.

HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved a second investigator-initiated trial (IIT) evaluating the safety and efficacy of HCB101 in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are refractory to platinum-based chemotherapy. The study will take place at Taipei Veterans General Hospital and Linkou Chang Gung Memorial Hospital. This marks the second TFDA-approval IIT of HCB101 in combination with standard-of-care (SOC) therapies, following the recently announced IIT approval for a metastatic colorectal cancer (mCRC) study. The new approval underscores HanchorBio’s strategic focus on expanding HCB101’s clinical development MOA (mode of action) based immunotherapy combinations across multiple solid tumors with unmet medical needs.

HanchorBio Inc., a global biotechnology company dedicated to developing innovative immuno-biomedicines to address significant unmet medical needs in oncology and autoimmune diseases, today announced the successful completion of its 5th semi-annual Scientific Advisory Board (SAB) meeting recently held in Taipei, Taiwan. The meeting brought together globally renowned scientific and clinical experts to provide strategic guidance to HanchorBio’s current preclinical and clinical R&D efforts and future development plans for advancing novel multi-functional biologics to treat cancer and autoimmune diseases.

HanchorBio Inc., a global biotechnology company dedicated to developing innovative immuno-medicines to address significant unmet medical needs in oncology and autoimmune diseases, has been awarded the 2025 Taiwan Biopharma Excellence Award at Biologics World Taiwan, hosted by IMAPAC. The company was also named “Company to Watch Out for in Taiwan”, recognizing its innovation, leadership, and growth potential in biologics development.
This industry recognition highlights HanchorBio’s significant progress in advancing its proprietary Fc-Based Designer Biologics (FBDB™) platform and underlines the company’s potential as it prepares for its next phase of corporate growth, including an anticipated IPO in Taiwan.

TAIPEI, SHANGHAI, and SAN FRANCISCO, March 24, 2025 – HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved an investigator-initiated trial (IIT) evaluating HCB101 in combination with cetuximab or bevacizumab and FOLFOX or FOLFIRI for advanced or metastatic colorectal cancer (CRC). The study will take place at Linkou Chang Gung Memorial Hospital under the leadership of Dr. Hung-Chih Hsu. This TFDA approval marks a significant step in expanding and advancing the clinical development of HCB101 through novel combinations with standard-of-care (SOC) therapies to meet unmet medical needs in the immunotherapy of solid tumors, including CRC.

HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the first patients with triple-negative breast cancer (TNBC) and gastric cancer (GC), respectively, were dosed in the Phase 1b/2a HCB101-201 clinical trial at Binzhou Medical University Hospital. This milestone marks the first-in-patient administration of HCB101 in combination with standard-of-care (SOC) therapies, leveraging its dual immune-modulating mechanisms to enhance tumor clearance in advanced solid tumors.