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 […]

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. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently developed novel drug candidate, HCB301 today.HCB301-101 is a multiregional, multicenter, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas in the US, Australia, and Taiwan. The study evaluates the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of weekly HCB301 intravenous injections. The HCB301 IND is on track to be reviewed by the Australia Therapeutic Goods Administration (TGA) and the Taiwan FDA.

Our mission is to transcend immuno-oncology therapies by developing cutting-edge designer biologics with novel modalities: Dr. Scott Liu of HanchorBio Inc.   “I envision that in five years, HanchorBio to be one of the leading biotech companies in immuno-oncology in the world through the development of safe and efficacious cutting-edge designer biologics with novel modalities.”  […]

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

1.Why was HanchorBio founded? 2.When was HanchorBio established, and what is its founding mission?3. What research achievements or fundraising successes has HanchorBio accomplished so far? 4.What is HanchorBio’s vision? 5.In the fields of biotechnology and healthcare, what contributions can HanchorBio make to society? 6.What are the key differences and advantages between HanchorBio’s drug candidates and traditional therapies? What is the core technology? 7.What is FBDB™? What makes it special, and how does it support research and development? 8.What is the expected scale or extent of the beneficiaries? For such multi-target biologics designed to reactivate the immune system against diseases, can this mechanism be applied to other diseases or medical fields?

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the US. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

HanchorBio Inc. completed a face-to-face Scientific Advisory Board (SAB) meeting on March 29, 2023, in Taipei, Taiwan withworld-renowned professors and few Board of Director (BOD) members.