{"success":true,"data":{"pressRelease":{"id":"138759","rtpr_id":"nPnbvTQSRa-20260909","ticker":"7827","exchange":"TWSE","all_tickers":["7827"],"title":"HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit","author":"PR Newswire","published_at":"2026-09-09T10:00:05.030Z","article_body":"HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit\n\nPR Newswire\n\nTAIPEI and SHANGHAI and SAN FRANCISCO, Sept. 9, 2026\n\nHCB101 represents the first known U.S. Expanded Access case for a SIRPα Fc\nfusion protein enabling continued therapy beyond the parent study.\n\nTAIPEI and SHANGHAI and SAN FRANCISCO, Sept. 9, 2026 /PRNewswire/\n-- HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology\ncompany developing next-generation immunotherapies for oncology and\nimmune-mediated diseases, today announced that the U.S. Food and Drug\nAdministration (FDA) has cleared its HCB101 Single-Patient Expanded Access\nProtocol (HCB101- EA-001) as \"safe to proceed\".\n\nThe FDA determination enables a patient who experienced clinical benefit while\nreceiving HCB101 in the Company's Phase 1 study to continue treatment with\nHCB101 beyond the parent clinical trial. Expanded Access, or compassionate\nuse, allows patients with serious or life-threatening diseases to receive\ninvestigational therapies outside standard clinical trials when specific\nregulatory criteria are met. In an individual-patient Expanded Access request,\nFDA considers the patient's clinical circumstances, including whether the\npotential benefit justifies the potential risks and whether those risks are\nreasonable in the context of the disease.\n\n\"For us, this starts with the patient,\" said Scott Liu, Ph.D., Founder and\nChairman of HanchorBio. \"When a patient is benefiting from an investigational\ntherapy and has limited treatment options, we believe every appropriate avenue\nto continue access should be considered. HCB101 was created to make a\nmeaningful difference, and this milestone reflects the patient-first principle\nguiding our FBDB™ platform.\"\n\nFDA's determination that HCB101-EA-001 is \"safe to proceed\" applies\nspecifically to this individual-patient Expanded Access protocol and does not\nconstitute approval of HCB101 or an FDA determination of efficacy.\n\n\"Working within the FDA framework, we translated an individual patient's need\ninto a practical solution allowing treatment to continue,\" said Alvin Luk,\nPh.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive\nOfficer (USA) of HanchorBio. \"That is where clinical medicine, regulatory\nscience, and drug development properly align.\"\n\nA Potential First for the SIRPα-Fc Fusion Protein Class\n\nWhile Expanded Access pathways have previously been utilized for the anti-CD47\nmonoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:\n\nTargeted Continuation: Unlike broad population access programs, HCB101-EA-001\nwas specifically established to extend treatment for an individual patient who\ndetermined clinical benefit during a Phase 1 clinical trial.\n\nNovel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to\nblock the CD47-SIRPα \"don't eat me\" signal and trigger macrophage-mediated\ntumor-cell phagocytosis.\n\nBased on publicly available information, HanchorBio believes this is the first\nreported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a\nsignificant precedent as HanchorBio continues to advance the program globally\nacross multiple tumor types and combination strategies.\n\nAbout HCB101\n\nHCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein\ndeveloped using HanchorBio's FBDB™ platform. HCB101 blocks CD47–SIRPα\nsignaling to restore macrophage-mediated antitumor immunity and downstream de\nnovo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and\nin combination (NCT06771622) across solid and hematologic malignancies and\nholds U.S. FDA Orphan Drug Designation for gastric cancer.\n\nAbout HanchorBio\n\nHanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company\nfocused on inventing next-generation biologics for cancer and immune-mediated\ndiseases using its proprietary FBDB™ platform. HanchorBio's pipeline\nincludes clinical-stage programs HCB101 and HCB301, next-generation\ntrispecific program HCB303, and additional candidates across oncology and\nimmune-mediated diseases.\n\nLearn more at http://hanchorBio.com (http://hanchorbio.com/)\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements regarding HCB101,\nincluding its clinical development, potential therapeutic benefits, regulatory\ninteractions, and the significance of the HCB101-EA-001 Expanded Access\nprotocol. These statements are subject to risks and uncertainties that could\ncause actual results to differ materially from those expressed or implied.\n\nHCB101 is investigational and has not been approved for commercial use by the\nU.S. FDA or any other regulatory authority. FDA's determination that\nHCB101-EA-001 is \"safe to proceed\" applies only to this specific Expanded\nAccess protocol and does not constitute approval of HCB101 or a determination\nof its safety or efficacy for a broader patient population.\n\nHanchorBio undertakes no obligation to update forward-looking statements\nexcept as required by applicable law.\n\nView original\ncontent:https://www.prnewswire.com/news-releases/hanchorbio-reaches-clinical-milestone-for-hcb101-as-us-fda-allows-continued-treatment-for-phase-1-patient-experiencing-clinical-benefit-302871871.html\n(https://www.prnewswire.com/news-releases/hanchorbio-reaches-clinical-milestone-for-hcb101-as-us-fda-allows-continued-treatment-for-phase-1-patient-experiencing-clinical-benefit-302871871.html)\n\nSOURCE HanchorBio Inc.\n\n\n\nIRPR@hanchorbio.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPnbvTQSRa-20260909","title":"HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit","author":"PR Newswire","ticker":"7827","created":"2026-09-09T10:00:05.030Z","tickers":["7827"],"exchange":"TWSE","article_body":"HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit\n\nPR Newswire\n\nTAIPEI and SHANGHAI and SAN FRANCISCO, Sept. 9, 2026\n\nHCB101 represents the first known U.S. Expanded Access case for a SIRPα Fc\nfusion protein enabling continued therapy beyond the parent study.\n\nTAIPEI and SHANGHAI and SAN FRANCISCO, Sept. 9, 2026 /PRNewswire/\n-- HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology\ncompany developing next-generation immunotherapies for oncology and\nimmune-mediated diseases, today announced that the U.S. Food and Drug\nAdministration (FDA) has cleared its HCB101 Single-Patient Expanded Access\nProtocol (HCB101- EA-001) as \"safe to proceed\".\n\nThe FDA determination enables a patient who experienced clinical benefit while\nreceiving HCB101 in the Company's Phase 1 study to continue treatment with\nHCB101 beyond the parent clinical trial. Expanded Access, or compassionate\nuse, allows patients with serious or life-threatening diseases to receive\ninvestigational therapies outside standard clinical trials when specific\nregulatory criteria are met. In an individual-patient Expanded Access request,\nFDA considers the patient's clinical circumstances, including whether the\npotential benefit justifies the potential risks and whether those risks are\nreasonable in the context of the disease.\n\n\"For us, this starts with the patient,\" said Scott Liu, Ph.D., Founder and\nChairman of HanchorBio. \"When a patient is benefiting from an investigational\ntherapy and has limited treatment options, we believe every appropriate avenue\nto continue access should be considered. HCB101 was created to make a\nmeaningful difference, and this milestone reflects the patient-first principle\nguiding our FBDB™ platform.\"\n\nFDA's determination that HCB101-EA-001 is \"safe to proceed\" applies\nspecifically to this individual-patient Expanded Access protocol and does not\nconstitute approval of HCB101 or an FDA determination of efficacy.\n\n\"Working within the FDA framework, we translated an individual patient's need\ninto a practical solution allowing treatment to continue,\" said Alvin Luk,\nPh.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive\nOfficer (USA) of HanchorBio. \"That is where clinical medicine, regulatory\nscience, and drug development properly align.\"\n\nA Potential First for the SIRPα-Fc Fusion Protein Class\n\nWhile Expanded Access pathways have previously been utilized for the anti-CD47\nmonoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:\n\nTargeted Continuation: Unlike broad population access programs, HCB101-EA-001\nwas specifically established to extend treatment for an individual patient who\ndetermined clinical benefit during a Phase 1 clinical trial.\n\nNovel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to\nblock the CD47-SIRPα \"don't eat me\" signal and trigger macrophage-mediated\ntumor-cell phagocytosis.\n\nBased on publicly available information, HanchorBio believes this is the first\nreported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a\nsignificant precedent as HanchorBio continues to advance the program globally\nacross multiple tumor types and combination strategies.\n\nAbout HCB101\n\nHCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein\ndeveloped using HanchorBio's FBDB™ platform. HCB101 blocks CD47–SIRPα\nsignaling to restore macrophage-mediated antitumor immunity and downstream de\nnovo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and\nin combination (NCT06771622) across solid and hematologic malignancies and\nholds U.S. FDA Orphan Drug Designation for gastric cancer.\n\nAbout HanchorBio\n\nHanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company\nfocused on inventing next-generation biologics for cancer and immune-mediated\ndiseases using its proprietary FBDB™ platform. HanchorBio's pipeline\nincludes clinical-stage programs HCB101 and HCB301, next-generation\ntrispecific program HCB303, and additional candidates across oncology and\nimmune-mediated diseases.\n\nLearn more at http://hanchorBio.com (http://hanchorbio.com/)\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements regarding HCB101,\nincluding its clinical development, potential therapeutic benefits, regulatory\ninteractions, and the significance of the HCB101-EA-001 Expanded Access\nprotocol. These statements are subject to risks and uncertainties that could\ncause actual results to differ materially from those expressed or implied.\n\nHCB101 is investigational and has not been approved for commercial use by the\nU.S. FDA or any other regulatory authority. FDA's determination that\nHCB101-EA-001 is \"safe to proceed\" applies only to this specific Expanded\nAccess protocol and does not constitute approval of HCB101 or a determination\nof its safety or efficacy for a broader patient population.\n\nHanchorBio undertakes no obligation to update forward-looking statements\nexcept as required by applicable law.\n\nView original\ncontent:https://www.prnewswire.com/news-releases/hanchorbio-reaches-clinical-milestone-for-hcb101-as-us-fda-allows-continued-treatment-for-phase-1-patient-experiencing-clinical-benefit-302871871.html\n(https://www.prnewswire.com/news-releases/hanchorbio-reaches-clinical-milestone-for-hcb101-as-us-fda-allows-continued-treatment-for-phase-1-patient-experiencing-clinical-benefit-302871871.html)\n\nSOURCE HanchorBio Inc.\n\n\n\nIRPR@hanchorbio.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-09-09T10:00:05.107143361Z","server_sent_at_ms":1788948005107},"received_at":"2026-09-09T10:00:05.156Z","source_url":"https://www.prnewswire.com/news-releases/hanchorbio-reaches-clinical-milestone-for-hcb101-as-us-fda-allows-continued-treatment-for-phase-1-patient-experiencing-clinical-benefit-302871871.html"},"analysis":{"id":"127599","press_release_id":"138759","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Single-patient Expanded Access clearance — the release explicitly states it is not an approval or FDA efficacy determination","Clinical benefit claim rests on one Phase 1 patient; 'clinical milestone' framing is promotional","HCB101 remains investigational with no commercial approval in any jurisdiction"],"eventType":"clinical_trial","narrative":"The U.S. FDA cleared HanchorBio's single-patient Expanded Access protocol HCB101-EA-001 as 'safe to proceed,' allowing a Phase 1 patient who experienced clinical benefit on HCB101 to continue treatment beyond the parent clinical trial.\n\nHanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein; HCB101 blocks the CD47–SIRPα 'don't eat me' signal to trigger macrophage-mediated tumor-cell phagocytosis and is built on the company's FBDB™ platform.\n\nThe clearance applies only to this individual protocol and does not constitute approval or an efficacy determination. HCB101 is in Phase 1 testing as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"First-of-class Expanded Access precedent for a SIRPα-Fc fusion protein — positive program signal but single-patient, non-approval news."},"keyFigures":{"drugName":"HCB101","phaseOfTrial":"Phase 1"},"quotedText":"When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered.","namedEntities":{"people":[{"name":"Scott Liu, Ph.D.","role":"Founder and Chairman of HanchorBio"},{"name":"Alvin Luk, Ph.D., M.B.A.","role":"President and Chief Medical Officer (Group) and Chief Executive Officer (USA)"}],"products":["HCB101","FBDB™ platform","HCB301","HCB303"],"companies":[{"name":"HanchorBio, Inc.","ticker":"7827","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"FDA cleared a single-patient Expanded Access protocol for HCB101 after a Phase 1 patient showed clinical benefit — a modest positive signal and a claimed first for the SIRPα-Fc class, but explicitly not an approval or efficacy determination."},"tickerRelevance":{"others":[],"primary":"7827"},"globalImportance":22,"audienceRelevance":15,"eventTypeSecondary":["regulatory"],"importanceComponents":{"tickerTier":"small-cap (TWSE-listed clinical-stage biotech)","eventGravity":"single-patient expanded access clearance, not approval","noveltyClaim":"first reported U.S. Expanded Access case for SIRPα-Fc class","sectorWeight":"clinical milestone with modest signal value","issuerAuthored":true}},"event_type":"clinical_trial","event_type_secondary":["regulatory"],"sentiment":"bullish","material_impact_score":2,"narrative":"The U.S. FDA cleared HanchorBio's single-patient Expanded Access protocol HCB101-EA-001 as 'safe to proceed,' allowing a Phase 1 patient who experienced clinical benefit on HCB101 to continue treatment beyond the parent clinical trial.\n\nHanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein; HCB101 blocks the CD47–SIRPα 'don't eat me' signal to trigger macrophage-mediated tumor-cell phagocytosis and is built on the company's FBDB™ platform.\n\nThe clearance applies only to this individual protocol and does not constitute approval or an efficacy determination. HCB101 is in Phase 1 testing as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.","key_figures":{"drugName":"HCB101","phaseOfTrial":"Phase 1"},"named_entities":{"people":[{"name":"Scott Liu, Ph.D.","role":"Founder and Chairman of HanchorBio"},{"name":"Alvin Luk, Ph.D., M.B.A.","role":"President and Chief Medical Officer (Group) and Chief Executive Officer (USA)"}],"products":["HCB101","FBDB™ platform","HCB301","HCB303"],"companies":[{"name":"HanchorBio, Inc.","ticker":"7827","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-09T10:03:17.514Z","global_importance":22,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap (TWSE-listed clinical-stage biotech)","eventGravity":"single-patient expanded access clearance, not approval","noveltyClaim":"first reported U.S. Expanded Access case for SIRPα-Fc class","sectorWeight":"clinical milestone with modest signal value","issuerAuthored":true}},"durationMs":32706,"modelName":"glm-5.3-flash"}}