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

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

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 • 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

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