News Category Development Progress

HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit

HanchorBio announced that the U.S. Food and Drug Administration (FDA) has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as “safe to proceed”.

Sep 09, 2026

HanchorBio Files U.S. IND for Second Trispecific Immunotherapy, HCB303

HanchorBio announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for HCB303. Developed using HanchorBio’s proprietary FBDB™ platform, HCB303 is the Company’s second trispecific immunotherapy program to reach clinical development.

Sep 03, 2026

HanchorBio Advances HCB101 Macrophage-Directed Immunotherapy Strategy with First Patient Dosed in Global HNSCC Study

HanchorBio announced that the first patient has been dosed in Cohort 6b of its global Phase 1b/2a HCB101-201 study (NCT06771622)

Aug 17, 2026

HanchorBio Receives FDA Pre-IND Feedback Supporting Advancement of HCB303, a Next-Generation Trispecific Immunotherapy

HanchorBio announced that it has received written responses from the U.S. Food and Drug Administration (FDA) following a Type B pre-Investigational New Drug (pre-IND) submission for HCB303, the Company’s next-generation, first-in-class trispecific immunotherapy designed to simultaneously activate innate and adaptive antitumor immunity.

Aug 12, 2026

HanchorBio and Taiwan Cancer Moonshot Team Led by Professor Sung-Liang Yu Establish Strategic Collaboration to Advance Precision Oncology

HanchorBio announced that its wholly owned Taiwan subsidiary has entered into a strategic collaboration with the research team led by Professor Sung-Liang Yu of National Taiwan University, a key participating team in the Taiwan Cancer Moonshot Program (TCMP). The collaboration has been formalized through a memorandum of understanding signed by HanchorBio Taiwan and Professor Yu’s team.

Aug 07, 2026

HanchorBio Expands Clinical Evidence Supporting Its Macrophage-Directed Oncology Strategy

HanchorBio announced updated early clinical observations from its HCB101 program.

Jul 22, 2026

HanchorBio and InxMed Sign Strategic MOU to Explore HCB101-Based Combination Therapies for Difficult-to-Treat Solid Tumors

HanchorBio announced that its subsidiary, FBD Biologics Limited, has signed a strategic memorandum of understanding (“MOU”) with InxMed (Shanghai) Co., Ltd. (“InxMed”).

Jul 08, 2026

HanchorBio Announces FDA Type C Meeting Minutes Supporting a Clear Development Path for HCB101 in Second-Line Gastric/GEJ Cancer

HanchorBio announced receipt of the official minutes from its recent U.S. Food and Drug Administration (FDA) Type C meeting regarding the post-Phase 1 development strategy for HCB101.

Jun 30, 2026

HanchorBio Presents Two Oral Presentations at ESMO TAT Asia 2026 Highlighting Progress Across Its Next-Generation Immunotherapy Pipeline

HanchorBio announced that two company-sponsored clinical programs were featured in oral presentations at the European Society for Medical Oncology Targeted Anticancer Therapies Asia Congress 2026, ESMO TAT Asia 2026, held in Hong Kong.

Jun 13, 2026

HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease

HanchorBio announced the presentation of late-breaking clinical and translational data at the Federation of Clinical Immunology Societies Annual Meeting, FOCIS 2026, being held June 9-12, 2026, in San Francisco.

Jun 10, 2026