Ramucirumab

China’s National Medical Products Administration has granted marketing authorization to Ennituo (anbenitamab; SYS6092; KN026 ), a recombinant humanised bispecific antibody co-developed by Shanghai JMT-BIO Technology — a subsidiary of CSPC Pharmaceutical Group and Jiangsu Alphamab Biopharmaceuticals, for the treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously received trastuzumab-containing therapy. The approval marks anbenitamab’s first cleared indication approval globally, and positions CSPC in a competitive second-line gastric cancer space increasingly defined by HER2-directed precision strategies. Ennituo is approved for use in combination with chemotherapy in this trastuzumab-pretreated population. Anbenitamab is an IgG1-type bispecific antibody that simultaneously engages two distinct, non-overlapping epitopes on HER2, a design intended to achieve more complete receptor blockade and enhanced internalization compared with conventional monospecific anti-HER2 agents. The molecule was originally developed by Alphamab Oncology using its proprietary CRIB heterodimer bispecific platform, with CSPC’s JMT-BIO subsidiary acquiring exclusive development and commercialisation rights for mainland China through a licensing agreement in August 2021. The approval rests primarily on data from KC-WISE, a pivotal Phase II/III trial enrolling patients with HER2-positive gastric or GEJ adenocarcinoma who had failed at least one prior line of therapy. Against standard chemotherapy alone, anbenitamab plus chemotherapy produced a progression-free survival of 7.1 months versus 2.7 months — a hazard ratio of 0.25, corresponding to a 75% reduction in the risk of disease progression or death. Overall survival reached 19.6 months in the combination arm compared with 11.5 months in the control arm (HR 0.25), a 71% reduction in mortality risk. Improvements in objective response rate and duration of response were also reported, with a safety profile described as favourable. The magnitude of the survival benefit observed in KC-WISE is notable in a disease setting where second-line options have historically offered modest gains. Anbenitamab’s dual-epitope engagement of HER2 is designed to prevent receptor re-expression and signalling through mechanisms that single-domain antibodies may not fully suppress, providing a mechanistic rationale for activity in patients who have already progressed on trastuzumab-based regimens. The most direct comparator in this space is fam-trastuzumab deruxtecan (Enhertu, T-DXd), the HER2-directed antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca, which carries FDA approval for HER2-positive gastric and GEJ adenocarcinoma in the post-trastuzumab setting based on the DESTINY-Gastric programme. Ramucirumab plus paclitaxel, approved for second-line gastric cancer regardless of HER2 status, remains a standard backbone against which novel agents in this line are benchmarked. Anbenitamab’s bispecific mechanism distinguishes it from both, though head-to-head data against these agents are not available from the source material. CSPC has also indicated that anbenitamab is under evaluation in HER2-positive breast cancer. A Phase III neoadjuvant study combining anbenitamab with HB1801 — the company’s proprietary albumin-bound docetaxel formulation — met its primary endpoint of total pathological complete response rate in March 2026. Registrational first-line breast cancer data from a separate Phase III study are expected later this year, suggesting the gastric approval may serve as a regulatory foundation for a broader oncology programme. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Global clinical-stage biotech x FBDB™ platform and multi-indication development strategy for lead program HCB101 TAIPEI, SHANGHAI, SAN FRANCISCO, May 28, 2026 /PRNewswire/ -- HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that it will be officially listed on the Taiwan Innovation Board on May 29, 2026, with an underwriting price of NT$120 per share. HanchorBio is focused on developing differentiated immunotherapies targeting large unmet needs in oncology and autoimmune diseases. The Company's core technology is its proprietary FBDB™ platform, which integrates multiple immune-modulating mechanisms into a single molecule and supports the development of multi-target, multifunctional biologic therapies. Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio, said platform technology is an important foundation for building long-term biotechnology value. By supporting the generation of multiple research and development assets over time, platform capabilities may help diversify risks associated with single-asset drug development while strengthening the long-term potential of the Company's pipeline. HanchorBio has built a pipeline of clinical and preclinical candidates, including HCB101, HCB301, HCB303, and HCB206. The Company's lead program, HCB101, is a CD47-targeting anti-cancer drug candidate designed through precision protein engineering to block tumor immune-evasion signals and restore macrophage-mediated tumor phagocytosis. HCB101 is currently being advanced in Phase 2a clinical development in combination with ramucirumab and paclitaxel for gastric cancer, while also being evaluated in additional indications, including head and neck cancer, colorectal cancer, and triple-negative breast cancer. HCB301, a trifunctional fusion protein designed to address three key tumor immune-escape mechanisms, has entered Phase 1 clinical trials in the United States, mainland China, and Taiwan. HCB303 is a next-generation multi-target immunotherapy candidate currently under clinical development planning, while HCB206, the Company's dual-mechanism autoimmune disease program, is viewed as an important potential driver of future pipeline value. Dr. Liu noted that, in biotechnology licensing and partnership discussions, early clinical data supported by proof-of-concept findings are often a key factor in attracting global pharmaceutical partners. Such data may provide initial evidence of safety, clinical activity, and potential differentiation in patients. HCB101 has shown encouraging early clinical activity in ongoing multinational Phase 1b/2a studies. In a mid-dose cohort evaluating HCB101 in combination with standard therapy for second-line gastric cancer, the regimen demonstrated an objective response rate (ORR) of 80%, with favorable safety and tumor reduction observations. Preliminary data from gastric cancer and first-line triple-negative breast cancer cohorts have also shown encouraging response and disease control signals. If subsequent Phase 2a proof-of-concept data across multiple indications remain supportive, the Company believes HCB101 may further positioned for global partnering discussions. HanchorBio is pursuing a multi-indication clinical development strategy for HCB101, designed to support flexible business development opportunities, including licensing, co-development, and potential strategic transactions. Following its licensing agreement last year with Henlius for the development and commercialization rights to HCB101 in mainland China and certain territories, valued at up to US$202 million, HanchorBio has continued to advance discussions with multiple global pharmaceutical companies. The Company is currently engaged in ongoing partnering discussions for global and regional rights to HCB101 outside previously licensed territories. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company's proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies. For more information, please visit: . SOURCE HanchorBio Inc. 21% more press release views with Request a Demo