Rui Lisheng (romiplostim biosimilar) / Qilu Pharma - LARVOL DELTA

A Multicenter, Single-Arm Study of Romiplostim N01 in Megakaryocytic Engraftment after Allogeneic Hematopoietic Stem Cell Transplantation for Bone Marrow Failure Diseases (ChiCTR) - P4 | N=35 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New P4 trial • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Transplantation

Romiplostim N01 for the treatment of cancer treatment-induced thrombocytopenia (ChiCTR) - P=N/A | N=950 | Not yet recruiting | Sponsor: Yidu Central Hospital of Weifang City; Yidu Central Hospital of Weifang City

New trial • Oncology • Thrombocytopenia

Single-center clinical study on the efficacy and safety of romiplostim N01 in promoting platelet engraftment after hematopoietic stem cell transplantation (ChiCTR) - P=N/A | N=88 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guilin Medical University; The First Affiliated Hospital of Guilin Medical University

New trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • NKG2D

To Observe the Efficacy of Romiplostim N01 in Promoting Platelet Engraftment and Treating Thrombocytopenia After HSCT (ChiCTR) - P4 | N=240 | Not yet recruiting | Sponsor: Wuhan Childrens Hospital; Wuhan Childrens Hospital

New P4 trial • Bone Marrow Transplantation • Hematological Disorders • Thrombocytopenia • Transplantation

A real-world study on the treatment of aplastic anemia with Romiplostim N01 (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: Hebei Province Hospital of Chinese Medicine; Hebei Province Hospital of Chinese Medicine

New P4 trial • Anemia • Aplastic Anemia • Hematological Disorders

A Single-Arm, Multicenter, Exploratory Study on the Efficacy and Safety of Romiplostim NO1 in Platelet Recovery After Autologous Hematopoietic Stem Cell Transplantation (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University

New trial • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Transplantation • CD34

ROMIPLOSTIM N01 FOR PROMOTING PLATELET ENGRAFTMENT AFTER ALLO-HSCT: INTERIM RESULTS OF A PHASE II EXPLORATORY TRIAL FROM NICHE COHORT (EBMT 2026) - "In summary, this interim analysis indicates that romiplostim N01 may accelerate platelet engraftment after allo-HSCT and demonstrated favorable tolerability and safety during the observation period; however, its clinical value requires confirmation in larger studies."

P2 data • Bone Marrow Transplantation • Hematological Malignancies • Thrombocytopenia

A prospective, single-arm study of romiplostim N01 for prevention of chemotherapy-induced thrombocytopenia in patients with non-Hodgkin's lymphoma (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Jiangxi Cancer Hospital; Jiangxi Cancer Hospital

New P4 trial • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia (clinicaltrials.gov) - P3 | N=210 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Anemia • Aplastic Anemia • Hematological Disorders

QL0911-302: QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (clinicaltrials.gov) - P2/3 | N=235 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Thrombocytopenia

An exploratory study of ropustine N01 in the treatment of thrombocytopenia (ctit) caused by immune combined with chemotherapy / targeted therapy in advanced solid tumors (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University

New trial • Gastric Cancer • Hematological Disorders • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia (clinicaltrials.gov) - P2/3 | N=63 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Feb 2024 | Trial primary completion date: May 2023 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia

QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (clinicaltrials.gov) - P2/3 | N=235 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2/3 trial • Hematological Disorders • Oncology • Thrombocytopenia

Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. (PubMed, J Transl Int Med) - P3 | "QL0911, a biosimilar to romiplostim (Nplate®), may be a novel treatment option for patients with ITP who have failed or relapsed from first-line treatment in China. Ongoing studies will provide further data on long-term efficacy and safety in such patient populations."

Clinical • Journal • P3 data • Hematological Disorders • Infectious Disease • Respiratory Diseases • Thrombocytopenia • Thrombocytopenic Purpura

EFFICACY AND SAFETY OF QL0911 IN ADULT PATIENTS WITH CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III TRIAL (EHA 2023) - P3 | "QL0911 was well tolerated, and increased and maintained platelet counts in adults with ITP. QL0911, as a biosimilar of romiplostim (Nplate®), may become a novel treatment option for ITP patients with failure or relapse from first-line treatment in China. Ongoing studies will provide further data as to long-term efficacy and safety in such patient populations."

Clinical • P3 data • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Nephrology • Respiratory Diseases • Thrombocytopenia • Thrombocytopenic Purpura

Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia (clinicaltrials.gov) - P2/3 | N=50 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2/3 trial • Hematological Disorders • Solid Tumor • Thrombocytopenia