HCB101 / HanchorBio, Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

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' (PRNewswire) - "The FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company's Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. Expanded Access, or compassionate use, allows patients with serious or life-threatening diseases to receive investigational therapies outside standard clinical trials when specific regulatory criteria are met....FDA's determination that HCB101-EA-001 is 'safe to proceed' applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy."

FDA event • Oncology

HCB101 Plus Ramucirumab and Paclitaxel in Second-line Advanced Gastric Cancer: Results From a Phase 1b/2a Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Gastric Cancer • Oncology • Solid Tumor

HCB101 as a Cross-GI Innate Immune Backbone: Clinical Validation in Gastric Cancer and Early Extension to Colorectal Cancer (ESMO 2026) - No abstract available

Clinical • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor

HCB101 as an Innate Immune Backbone for PD-1-Based Combinations: Early Clinical Signals in HNSCC and TNBC (ESMO 2026) - No abstract available

Clinical • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-1

HanchorBio Tests Broader Ambitions for HCB101 Through InxMed Partnership (PRNewswire) - "Under the MOU, the two companies will conduct preclinical and translational research evaluating HCB101 in combination with InxMed's investigational assets, including IN10018/ifebemtinib, a FAK inhibitor, and OMTX705....HanchorBio has been developing the asset with gastric cancer as an important clinical anchor....InxMed brings a complementary profile. Its lead asset, IN10018/ifebemtinib, has advanced into late-stage clinical development, including a Phase III trial in China for platinum-resistant recurrent ovarian cancer....The collaboration gives HanchorBio a way to test whether HCB101's macrophage-centered immune activation can be paired with drugs targeting the tumor's physical and biological defenses, including fibrosis, stromal barriers, and immune exclusion."

Licensing / partnership • Platinum resistant • Gastric Cancer • Ovarian Cancer

HCB101 GC GEJ: Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Early Safety and Antitumor Activity of HCB101 Plus Ramucirumab and Paclitaxel in Second-line Advanced Gastric Cancer: Results from a Phase 1b/2a Trial (ESMO-GI 2026) - No abstract available

Clinical • Metastases • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The differentiated SIRPα–IgG4 Fc fusion protein HCB101 in monotherapy and combination therapy. (ASCO 2026) - P1, P1/2 | "In HCB101-201, 2L-GC treated with HCB101 plus ramucirumab and paclitaxel demonstrated 8 PRs and 5 SDs, with two additional patients at 12 mg/kg pending first assessment. HCB101 demonstrates a class-distinguishing profile for a macrophage checkpoint inhibitor, with durable monotherapy antitumor activity and a wide therapeutic window up to 36 mg/kg, addressing long-standing limitations of CD47-directed therapies. The early and reproducible combination activity across multiple solid tumors, including GC, HER2+ GC, and TNBC, has supported rapid cohort expansion. These data position HCB101 as a next-generation innate immune checkpoint backbone with broad clinical applicability and a clear rationale for future combination-based registrational development."

Combination therapy • First-in-human • IO biomarker • Monotherapy • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lymphoma • Marginal Zone Lymphoma • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2 • SIRPA

HCB101 as a Cross-GI Innate Immune Backbone: Clinical Validation in Gastric Cancer and Early Extension to Colorectal Cancer (ESMO-GI 2026) - No abstract available

Clinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Early Clinical Activity of the Novel SIRPαIgG4 Fc Fusion Protein HCB101 in Combination with AntiPD-1 and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer (GBCC 2026) - P1/2 | "The triplet combination of HCB101, anti-PD-1 therapy, and nab-paclitaxel demonstrated uniform early disease control and encouraging antitumor activity in this initial TNBC cohort. These findings support further dose expansion and continued clinical development of HCB101-based macrophage-checkpoint immunotherapy combinations in advanced TNBC."

Clinical • Combination therapy • IO biomarker • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • SIRPA

HanchorBio Reports Preliminary First-Line HER2+ Gastric Cancer Data for HCB101, Demonstrating 83.3% ORR (HanchorBio Press Release) - "Among 6 efficacy-evaluable patients treated across multiple dose levels (5.12, 8, and 12 mg/kg), 5 achieved confirmed partial responses (PRs), yielding an objective response rate (ORR) of 83.3%. The disease control rate (DCR) was 100%. Tumor reductions were observed in all evaluable patients, with multiple cases demonstrating deep responses ranging from -30% to -65%. Responses have been observed across dose levels, with patient follow-up ongoing. While the dataset remains early and limited in size, the observed ORR compares favorably with historical benchmarks for standard-of-care first-line HER2-positive gastric cancer regimens..."

P1/2 data • Gastric Cancer

Shanghai Henlius Biotech…announced that the first patient has been dosed in a Phase 1b/2 trial (HLX701-CRC201) evaluating its novel recombinant human SIRPα-Fc fusion protein, HLX701, in combination with cetuximab and chemotherapy in patients with advanced RAS/BRAF wild-type metastatic colorectal cancer (mCRC) (Henlius Press Release) - "This Phase 1b/2 clinical study compares HLX701 in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI) versus placebo in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI) in patients with recurrent, unresectable, or metastatic RAS/BRAF wild-type colorectal cancer who have previously received chemotherapy."

Trial status • Colorectal Cancer

Early safety, pharmacokinetics, and translational profiling of HCB101 in combination with standard-of-care regimens: Results from the phase Ib/IIa HCB101-201 study (ESMO-TAT 2026) - P1, P1/2 | "HCB101 demonstrates favorable combination tolerability, preserved PK and RO, and early signals of biological activity across diverse SOC backbones. These results support the further development of HCB101 as a differentiated innate checkpoint backbone for combination strategies in solid tumors."

Clinical • Combination therapy • IO biomarker • P1/2 data • PK/PD data • Breast Cancer • Gastric Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • SIRPA

First-in-human phase I evaluation of HCB101, a SIRPα–Fc innate checkpoint fusion protein: Safety, pharmacokinetics, and receptor occupancy (ESMO-TAT 2026) - P1 | "HCB101 demonstrates a favorable safety profile, dose-proportional PK, and near-complete target engagement at biologically active exposures. These findings support continued dose escalation and the further development of HCB101 as a macrophage checkpoint backbone therapy in solid tumors."

Clinical • First-in-human • P1 data • PK/PD data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • SIRPA

Phase 1 Monotherapy and Combination Data for HCB101, a Novel SIRPα–Fc Innate Checkpoint Fusion Protein (AACR-IO 2026) - P1, P1/2 | "HCB101-201 (NCT06771622) is a Phase 1b/2a study evaluating HCB101 in combination with standard-of-care backbones across multiple tumor types, including chemo-, VEGF-, HER2-, PD-1-, and EGFR-directed regimens such as ramucirumab + paclitaxel in gastric cancer. In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr B076."

IO biomarker • Monotherapy • P1 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lymphoma • Marginal Zone Lymphoma • Ovarian Cancer • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • CD47 • EGFR • HER-2 • SIRPA

HanchorBio Presents Dose-Dependent Tumor Responses and Deepening Tumor Shrinkage with HCB101 Triple Combination in Second-Line Gastric Cancer at the 11th Asia-Pacific Gastroesophageal Cancer Congress (HanchorBio Press Release) - "Early clinical data show 100% ORR at 5.12 mg/kg, 100% DCR across doses, and dose-dependent tumor shrinkage; the 12 mg/kg cohort remains ongoing....Efficacy (15 efficacy-evaluable patients across dose levels). Objective response rate (ORR) by dose: 2.56 mg/kg: 0%; 5.12 mg/kg: 100%; 8 mg/kg: 81%; 12 mg/kg (ongoing): preliminary ORR observed to date. Disease control rate (DCR): 100% across all doses. Mean tumor shrinkage by dose: 2.56 mg/kg: –6.0%; 5.12 mg/kg: –33.4%; 8 mg/kg: –46.0%; 12 mg/kg: –27.9% (data continue to mature)."

P1/2 data • Gastric Cancer

HCB101-201: Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=500 | Active, not recruiting | Sponsor: FBD Biologics Limited | Recruiting ➔ Active, not recruiting | N=150 ➔ 500

Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer (PRNewswire) - "HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer."

Orphan drug • Gastric Cancer

HCB101-101: A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: FBD Biologics Limited | N=60 ➔ 80

Enrollment change • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

HanchorBio Secures Japanese Patent for Engineered SIRPα-IgG4 Fusion Protein HCB101 (HanchorBio Press Release) - "The granted patent, titled 'ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF' (Engineered SIRPα Variants and Methods of Use Thereof), reinforces HanchorBio’s intellectual property position in one of the world’s most rigorous and strategically important pharmaceutical jurisdictions.....The granted Japanese patent covers core engineered features of these SIRPα variants and their therapeutic use, reinforcing long-term differentiation and combination flexibility across solid tumor indications."

Patent • Solid Tumor

Henlius Biotech…announced that recently, the Investigational New Drug (IND) application for a Phase 1b/2 clinical trial of HLX701 (recombinant human SIRPα-IgG4 Fc fusion protein injection) (“HLX701”) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer has been approved by the National Medical Products Administration (NMPA). (FUTU)

New P1/2 trial • Colorectal Cancer

Dose-dependent antitumor activity of HCB101 plus ramucirumab and paclitaxel in previously treated gastric cancer. (ASCO-GI 2026) - P1/2 | "HCB101 combined with ramucirumab and paclitaxel demonstrated manageable safety and promising dose-dependent antitumor activity in 2L gastric cancer. While the 2.56 mg/kg dose showed disease stabilization, all evaluable participants in the 5.12 and 8.00 mg/kg cohorts achieved PRs, suggesting the presence of a therapeutic window. These early findings support continued investigation of HCB101 as a differentiated CD47-SIPRa therapy with potential to reprogram the gastric tumor microenvironment and improve outcomes for patients with previously treated advanced gastric cancer."

Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • SIRPA

HCB101, a differentiated SIRpα-fc fusion protein, demonstrates favorable safety and early antitumor activity across solid tumors and lymphomas (ESMO-IO 2025) - P1, P1/2 | "In HCB101-201, combinations showed striking efficacy: in 2L GC, HCB101 with ramucirumab and paclitaxel achieved 100% ORR (6/6) at 5.12–8.0 mg/kg, with regressions up to –78.2%, far exceeding historical benchmarks (∼28%). Safety across combination cohorts was consistent with known SOC toxicities and manageable with standard interventions, with no new immune-related or off-target safety signals attributable to HCB101.Conclusions HCB101 demonstrates a favorable safety profile, durable monotherapy activity in HNSCC and NHL, and striking combination efficacy in GC and TNBC. These data establish HCB101 as a differentiated SIRPα-CD47 therapy with the potential to overcome class limitations and support registrational development across multiple tumor types."

Clinical • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • SIRPA

First-in-human phase I study of HCB101, a 3.5th-generation CD47-SIRPα fc fusion protein: Cytopenia-sparing safety, broad pharmacologic window, and low-dose clinical activity in relapsed/refractory non-Hodgkin lymphoma (ASH 2025) - P1 | "HCB101, a 3.5th-generation CD47-SIPRα Fc fusion protein, demonstrates a favorable, cytopenia-sparingsafety profile (no DLTs, no Grade ≥3 TRAEs), a low-dose PD saturation (≥90% RO at 1.28 mg/kg and ≥99%RO at 5 mg/kg; MTD not reached at >24 mg/kg), and durable monotherapy activity at 8.00 mg/kg inheavily pretreated R/R NHL. Compared with earlier CD47-targeting modalities, including first-generationantibodies (e.g., Gilead, I-MAB) and second-generation wild-type SIRPα-Fc fusions (e.g., Pfizer,ImmuneOnco), HCB101 achieves superior receptor occupancy, safety beyond 24.0 mg/kg, and earlyclinical efficacy at 8.00 mg/kg – well below the upper dose levels – supporting a broad pharmacologicwindow. The selective CD47-SIRPα fusion design distinguishes HCB101 from first-generation antibodies,which are limited by anemia and dosing complexity."

Clinical • First-in-human • IO biomarker • P1 data • B Cell Lymphoma • Hematological Malignancies • Leukopenia • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Solid Tumor • Thrombocytopenia • CD47 • SIRPA

Key Findings Highlighted in the Mini-Oral: Monotherapy (HCB101-101; NCT05892718) (PRNewswire) - "HanchorBio Announces oral presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025....Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW....Durable antitumor activity, including confirmed PRs in: HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks); MZL - Marginal zone lymphoma (~89% tumor regression, ≥16 weeks); Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma."

P1 data • Colorectal Cancer • Marginal Zone Lymphoma • Non Small Cell Lung Cancer • Ovarian Cancer • Sarcoma • Squamous Cell Carcinoma of Head and Neck