HCB101 / HanchorBio, Fosun Pharma - LARVOL DELTA

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

HCB101-201: 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

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

Key Findings Highlighted in the Mini-Oral:…Combination Therapy (HCB101-201; NCT06771622) (PRNewswire) - "HanchorBio Announces oral presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025....Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC. No new safety signals across all evaluated combinations....2L GC: 58.3% ORR (7/12) for all cohorts evaluated, 77.8% ORR (7/9) for mid-dose cohorts, and 100% DCR; Tumor shrinkage up to -78.2%; 1L HER2+ GC: 33% ORR (1/3); 1L TNBC: 50% ORR (3/6) and 100% DCR."

P1/2 data • Colorectal Cancer • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

HanchorBio Presents First-in-Human Data of HCB101 Monotherapy in Relapsed/Refractory Non-Hodgkin Lymphoma at ASH 2025 (PRNewswire) - "Key Results (data cutoff: October 14, 2025): Thirteen patients with R/R NHL received HCB101 (5.12 – 24.0 mg/kg QW). No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. All treatment-related adverse events were Grade 1-2, confirming a cytopenia-sparing safety profile. CD47 receptor occupancy (RO) reached ≥ 75-85% at 1.2 mg/kg and ≥ 90% at 8 mg/kg, demonstrating a broad pharmacologic window."

First-in-human • P1 data • Non-Hodgkin’s Lymphoma

HanchorBio Presents First-in-Human Phase 1 Data of HCB101 at the 67th American Society of Hematology (ASH) Annual Meeting (HanchorBio Press Release) - "The accepted abstract (#3299) includes a focused sub-analysis from HanchorBio’s ongoing multinational, open-label Phase 1 study evaluating HCB101 monotherapy across solid and hematologic malignancies, highlighting results from the R/R NHL cohort. HCB101 demonstrated a cytopenia-sparing safety profile along with early signals of clinical activity, representing a meaningful advancement in CD47–SIRPα therapeutic design."

P1 data • Non-Hodgkin’s Lymphoma

Title: Phase 1b/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors (PRNewswire) - "HanchorBio Presents...Late-Breaking Abstracts at the Society for Immunotherapy of Cancer 2025....In second-line gastric cancer (GC): 100% confirmed partial response rate (6/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel. Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW. In first-line triple-negative breast cancer (TNBC): Confirmed partial response with 73% tumor reduction at the effective dose."

Late-breaking abstract • P1/2 data • Gastric Cancer • Triple Negative Breast Cancer

Title: HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers (PRNewswire) - "HanchorBio Presents...Late-Breaking Abstracts at the Society for Immunotherapy of Cancer 2025....In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg/kg. CD47 receptor occupancy ≥99% achieved at doses ≥5 mg/kg, with dose-proportional pharmacokinetics. Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL). Several patients achieved stable disease, with progression-free survival up to 32 weeks."

Late-breaking abstract • P1 data • Marginal Zone Lymphoma • Squamous Cell Carcinoma of Head and Neck

HanchorBio will also present two late-breaking abstracts on November 7 to showcase clinical data on its SIRPα-Fc fusion protein HCB101…at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)… (PRNewswire)

Clinical data • Late-breaking abstract • Oncology

Phase Ib/IIa Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors (SITC 2025) - P1, P1/2 | "Cohorts included: a) second-line (2L) GC (HCB101 plus ramucirumab and paclitaxel); and b) first-line (1L) TNBC (HCB101 plus toripalimab and nab-paclitaxel). NCT06771622Ethics Approval The study was approved by following ethics committees: 1.Cancer Hospital of Shandong First Medical University Ethics Committee; Number of theapproval: SDZLEC2024-412-04; 2.The Fifth Affiliated Hospital, Sun Yat-sen University Ethics Committee; Number of the approval:2025-Y241-3; 3.Dongguan People's Hospital Ethics Committee; Number of the approval: DRYA2025-015-B3; 4.Qilu Hospital of Shandong University Dezhou Hospital Ethics Committee; Number of the approval: 2025-003-002; 5.Binzhou Medical University Affiliated Hospital Ethics Committee; Number of the approval: 2025-011-03; Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this..."

Clinical • Late-breaking abstract • Metastases • P1/2 data • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD47 • SIRPA

HCB101, a Next-Generation Fc-Engineered anti-CD47 SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers (SITC 2025) - "Dezhou Hospital of Qilu Hospital of Shandong University Ethics Committee; Number of the approval: 2025-008-003.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • IO biomarker • Late-breaking abstract • Metastases • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD47 • SIRPA

HCB101: a novel potent ligand-trap Fc-fusion protein targeting the CD47-SIRPα pathway with high safety and preclinical efficacy for hematological and solid tumors. (PubMed, J Hematol Oncol) - "HCB101 demonstrates high-affinity binding to CD47, robustly promotes macrophage-mediated phagocytosis of tumor cells without affecting red blood cells and exhibits unique advantages over current CD47-targeting agents, including Hu5F9-G4, TTI-622, and ALX148. Additionally, HCB101 treatment increased the M1/M2 macrophage ratio in the tumor microenvironment, suggesting repolarization of tumor-associated macrophages (TAMs) toward a pro-inflammatory phenotype. No dose-limiting toxicities or hematologic adverse effects were observed in murine or non-human primate studies."

IO biomarker • Journal • Preclinical • Hematological Disorders • Oncology • Solid Tumor • CD47 • SIRPA

HanchorBio Presents Phase 1 HCB101 Clinical Results at FACO 2025 Demonstrating Safety and Early Antitumor Activity (PRNewswire) - "Key highlights from the study as of July 10, 2025, include: Favorable safety profile: Among 49 patients enrolled across 10 dose levels (0.08-18.00 mg/kg, QW), only one dose-limiting toxicity (DLT) was observed, a transient Grade 3 thrombocytopenia at the 2.56 mg/kg dose level....; Encouraging antitumor activity: Two confirmed partial responses (PRs) in head and neck squamous cell carcinoma (HNSCC) and non-Hodgkin lymphoma, alongside durable disease control in multiple patients."

P1 data • Non-Hodgkin’s Lymphoma • Squamous Cell Carcinoma of Head and Neck

HanchorBio today announced that its proprietary HCB101…has been officially granted a US patent (Patent No. 12,447,195) by the United States Patent and Trademark Office (USPTO) (PRNewswire) - "...The patent represents major international recognition for the company's innovative technology for immuno-oncology....The USPTO recognized HCB101's original mutation design and unprecedented potency as clear evidence of novelty and inventive step....Following this US patent grant, HanchorBio will advance patent filings across Europe, Taiwan, and other Asian countries as part of its broader global IP roadmap."

Patent • Oncology

HanchorBio Showcases Pipeline Momentum with HCB101…Data Across...Major Oncology Meetings in Q4 2025 (PRNewswire) - "HanchorBio...announced that new clinical data from HCB101, its differentiated, engineered SIRPα-Fc fusion protein...will be presented at...major international oncology congresses in the fourth quarter of 2025. The upcoming presentations will showcase progress from HCB101, including both the HCB101-101 monotherapy (NCT05892718) and the HCB101-201 combination (NCT06771622) studies..."

Clinical data • Lymphoma • Solid Tumor

The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Chang Gung Memorial Hospital

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial) (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Taipei Veterans General Hospital, Taiwan

New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

HanchorBio Receives Third Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Gastric Cancer (HanchorBio Press Release) - "HanchorBio...announced that the Taiwan Food and Drug Administration (TFDA) has approved a third investigator-initiated trial (IIT) evaluating HCB101 in combination with zolbetuximab and chemotherapy for the first-line treatment of patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will be conducted at Kaohsiung Medical University Chung-Ho Memorial Hospital....The open-label, dose-escalation, and dose-expansion trial (HCB101-IIT-GC-202501) is designed to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination with zolbetuximab and chemotherapy in patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or GEJ adenocarcinoma who have progressed following prior standard therapy."

New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: FBD Biologics Limited | Trial completion date: Nov 2025 ➔ Nov 2029 | Trial primary completion date: May 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor