Pegberon (ypeginterferon alpha-2b) / Xiamen Amoytop Biotech - LARVOL DELTA

Long-term outcomes of a novel initial regimen: Rituximab plus pegylated interferon α-2b in untreated advanced indolent B-cell lymphoma – 5-year follow-up of the ripple study (ASH 2025) - P2 | "Induction therapy consisted of rituximab biosimilar (Henliritux®; 375mg/m² IV on day 1) plus Peg-IFN-α2b (Pegberon®; 135μg SC on days 1 and 8) every 21 days for 6 cycles.Responders received maintenance (rituximab every 8 weeks; Peg-IFN-α2b monthly) for ≤2 years. Rituximab biosimilar with Peg-IFN-α2b demonstrates durable efficacy and manageabletoxicity in treatment-naïve iBCL, particularly in FL and MALT subtypes. Absence of HBV reactivationsuggests potential synergism between Peg-IFN-α2b and entecavir in HBV suppression. These resultssupport further evaluation in larger randomized trials."

Metastases • B Cell Lymphoma • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatitis C • Hepatology • Immune Modulation • Immunology • Indolent Lymphoma • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Small Lymphocytic Lymphoma • Thrombocytopenia • Waldenstrom Macroglobulinemia • IFNA1

Efficacy and safety of entecavir, peginterferon alfa-2b and GM-CSF combination therapy: the anchor randomized controlled trial. (PubMed, Hepatol Int) - P3 | "In virally suppressed patients with HBsAg level < 3000 IU/mL, ETV plus Peg-IFN significantly increased HBsAg loss and HBsAg seroconversion, whereas adding GM-CSF conferred no additional efficacy benefit. Age, early on-treatment HBsAg level and 24-week HBV RNA decline correlated with HBsAg loss. This trial is registered at ClinicalTrials.gov, NCT02327416."

Journal • Hepatitis B • Infectious Disease • Inflammation • CSF2

Novel Chemotherapy-Free Initial Treatment of Rituximab Biosimilar Plus Pegylated Interferon α-2b in Pts with Untreated Advanced Indolent B-Cell Non-Hodgkin's Lymphoma: Results of the Ripple 3-Year Follow-up Study (ASH 2023) - P2 | "During induction phase, pts received rituximab biosimilar (Henliritux® Shanghai Henlius Biotech) 375 mg/m2 intravenous infusion on d1. Peg-IFN-α2b (Pegberon®, Xiamen Amoytop Biotech) was given at a dose of 135ug, subcutaneously, on d1,8...Simultaneously, CHB pts orally treated with entecavir continuously... Rituximab biosimilar plus pegylated interferon α-2b provided favorable response in newly diagnosed advanced iBCL with mild toxicity. No hepatitis B virus reactivation was observed."

Clinical • Metastases • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Fatigue • Follicular Lymphoma • Hematological Malignancies • Hepatitis B • Hepatology • Indolent Lymphoma • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Small Lymphocytic Lymphoma • Thrombocytopenia • Waldenstrom Macroglobulinemia • IFNA1

Drug Repositioning of Pegbing® for Essential Thrombocythemia: Insights from PK/PD Modeling and Extrapolation. (PubMed, Clin Pharmacol Ther) - "A higher maintenance dose may be required in patients with severe ET. Moreover, this study provides a valuable reference for drug repositioning between two indications with significant differences."

Journal • PK/PD data • Essential Thrombocythemia • Hematological Disorders • Hepatitis B • Infectious Disease • Inflammation • Myeloproliferative Neoplasm • Thrombocytosis

Combination therapy of entecavir, peginterferon alpha and granulocyte-macrophage colony stimulating factor enhanced HBsAg loss and HBsAb response (EASL 2025) - "In virally-suppressed patients with CHB, combination of ETV and Peg-IFN with or without GM-CSF improved the rates of HBsAg loss and HBsAb positivity. HBsAg trajectory may accurately predict HBsAg loss under Peg-IFN-based therapy."

Combination therapy • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CSF2

Combination therapy of entecavir, peginterferon alpha and granulocyte-macrophage colony stimulating factor enhanced HBsAg loss and HBsAb response (APASL 2025) - "In virally-suppressed patients with CHB, combination of ETV and Peg-IFN with or without GM-CSF improved the rates of HBsAg loss and HBsAb positivity. HBsAg trajectory may accurately predict HBsAg loss under Peg-IFN-based therapy."

Combination therapy • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CSF2

Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Essential Thrombocythemia • Hematological Disorders • Myeloproliferative Neoplasm • Thrombocytosis

A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P=N/A | N=350 | Enrolling by invitation | Sponsor: Xiamen Amoytop Biotech Co., Ltd.

New trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (ChiCTR) - P2 | N=27 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Institute of Hematology

New P2 trial • Essential Thrombocythemia • Hematological Disorders • Myeloproliferative Neoplasm • Thrombocytosis

Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET (clinicaltrials.gov) - P2 | N=27 | Not yet recruiting | Sponsor: Xiamen Amoytop Biotech Co., Ltd.

New P2 trial • Essential Thrombocythemia • Hematological Disorders • Myeloproliferative Neoplasm • Thrombocytosis

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P3 | N=475 | Completed | Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Rituximab Biosimilar Combined with Pegylated Interferon α-2b in Patients with Untreated Advanced Indolent B-Cell Non-Hodgkin's Lymphoma: Preliminary Results from a Multicenter, Single-Arm, Phase II Study (ASH 2021) - P2 | "During induction phase, pts received rituximab biosimilar (Henliritux ® Shanghai Henlius Biotech) 375 mg/m 2 intravenous infusion on d1. Peg-IFN-α2b (Pegberon ® , Xiamen Amoytop Biotech) was given at a dose of 135ug, subcutaneously, on d1,8...Simultaneously, CHB pts orally treated with entecavir continuously... Rituximab biosimilar plus pegylated interferon α-2b provided favorable response in newly diagnosed advanced iBCL and was well tolerated. No hepatitis B virus reactivation was observed. Further investigation is warranted."

Clinical • P2 data • Anemia • Fatigue • Hematological Malignancies • Hepatitis B • Hepatology • Indolent Lymphoma • Infectious Disease • Inflammation • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • IFNA1

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P3 | N=475 | Active, not recruiting | Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Trial completion date: Sep 2023 ➔ Dec 2023 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

[VIRTUAL] Short-term peginterferon alpha re-treatment induced a high functional cure rate in patients with hepatitis B surface antigen recurrence after cessation of peginterferon alpha-based regimens (EASL-ILC 2021) - "All patients received an individualized peg-IFN alpha −2b (PegBeron, 180 μg, subcutaneous injection, once weekly, Chinese-made) re-treatment... High rate of HBsAg clearance can be achieved by short- course of peg-IFN alpha-2b re-treatment in patients with HBsAg recurrence after cessation of peg-IFN alpha-based regimens."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • IFNA1

Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy (clinicaltrials.gov) - P=N/A; N=473; Completed; Sponsor: Xiamen Amoytop Biotech Co., Ltd.; Enrolling by invitation ➔ Completed; N=775 ➔ 473

Enrollment change • Trial completion • Hepatitis B • Hepatology • Infectious Disease

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P3; N=475; Active, not recruiting; Sponsor: Xiamen Amoytop Biotech Co., Ltd.

New P3 trial • Hepatitis B • Hepatology • Infectious Disease

Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B (clinicaltrials.gov) - P3; N=820; Completed; Sponsor: Xiamen Amoytop Biotech Co., Ltd.; Active, not recruiting ➔ Completed

Trial completion