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

Efficacy and Safety of Romiplostim N01 for Injection in Promoting Platelet Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=87 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

New P2 trial • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Thrombocytopenia • Transplantation

QL0911-302: QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (clinicaltrials.gov) - P2/3 | N=235 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Trial completion date: Dec 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Oncology • Thrombocytopenia

Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia (clinicaltrials.gov) - P2 | N=97 | Recruiting | Sponsor: Anhui Provincial Hospital | Trial primary completion date: Jun 2026 ➔ Jan 2027

Trial primary completion date • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer (clinicaltrials.gov) - P2 | N=53 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Thrombocytopenia

A Single-Center, Prospective, Real-World Study to Evaluate the Efficacy and Safety of Romiplostim N01 (Ruilisheng) in Patients with Solid Tumors and Cancer TherapyInduced Thrombocytopenia (CTIT) (ChiCTR) - P4 | N=211 | Not yet recruiting | Sponsor: The Fourth Hospital of Hebei Medical University; The Fourth Hospital of Hebei Medical University

New P4 trial • Real-world evidence • Oncology • Solid Tumor • Thrombocytopenia

Romiplostim N01 for Sepsis-associated Thrombocytopenia: A Single-center, Single-arm Clinical Study (ChiCTR) - P=N/A | N=36 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

New trial • Hematological Disorders • Infectious Disease • Septic Shock • Thrombocytopenia

Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia (clinicaltrials.gov) - P2 | N=97 | Recruiting | Sponsor: Anhui Provincial Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

The efficacy and safety of Romiplostim N01 combined with Glucocorticoids as first-line treatment for immune thrombocytopenia. (ISTH 2026) - P2 | "The treatment regimen consisted of romiplostim N01 at a starting dose of 3 μg/kg in combination with either dexamethasone (40 mg/day for 4 days) or conventional-dose prednisone (1 mg/kg/day). Conclusions This combined therapy as a first-line treatment for ITP patients has demonstrated good efficacy and safety characteristics, and is expected to offer a new and promising first-line treatment option for ITP patients. Table or Figure Upload (1) Table 1 Patients characteristic Page 2 Table or Figure Upload (2) Table2 Results in romiplostim N01 combined with glucocorticoids treatment DOI*10.1016/j.rpth.2026.104467"

Clinical • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia (clinicaltrials.gov) - P3 | N=210 | Sponsor: Qilu Pharmaceutical Co., Ltd.

Trial initiation date • Anemia • Aplastic Anemia • Hematological Disorders

ROMIPLOSTIM N01 FOR PLATELET RECOVERY AFTER UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES: A PHASE II, SINGLE-ARM STUDY (EHA 2026) - "Summary/Conclusion In this interim analysis, romiplostim N01 may promote platelet engraftment and recovery after unrelated UCBT, with no treatment- related SAEs. Final analyses are ongoing."

Clinical • P2 data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Cytomegalovirus Infection • Extranodal Natural Killer/T-cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Transplantation • CD34

A PROSPECTIVE, SINGLE-ARM STUDY OF ROMIPLOSTIM N01 FOR PLATELET ENGRAFTMENT AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE MYELOMA (EHA 2026) - "All patients received melphalan conditioning prior to autologous stem cell transplantation, followed by administration of romiplostim N01 starting on day +1 post- transplantation. Summary/Conclusion This study will provide prospective evidence on the efficacy and safety of romiplostim N01 for promoting platelet engraftment in MM patients post-ASCT. The preliminary findings are expected to support its potential as a treatment option to reduce post-transplant bleeding complications and platelet transfusion dependency, thereby improving patient outcomes."

Clinical • Hematological Disorders • Hematological Malignancies • Immune Thrombocytopenic Purpura • Multiple Myeloma • Thrombocytopenia • Thrombocytopenic Purpura • Transplantation

ROMIPLOSTIM N01 AS SWITCH THERAPY IN CANCER THERAPY-RELATED THROMBOCYTOPENIA: A REAL-WORLD STUDY (EHA 2026) - "The differential responses across etiological subgroups highlight the importance of etiology-guided treatment strategies. Long-term safety requires validation in future prospective studies."

Clinical • Real-world • Real-world evidence • Aplastic Anemia • Immune Thrombocytopenic Purpura • Oncology • Solid Tumor • Thrombocytopenia • Thrombocytopenic Purpura

ROMIPLOSTIM N01 FOR PROMOTING PLATELET ENGRAFTMENT AFTER ALLO-HSCT: INTERIM RESULTS OF A PHASE II EXPLORATORY TRIAL FROM NICHE COHORT (EHA 2026) - "No treatment-interrupting or treatment-related adverse events were observed through last follow-up. Summary/Conclusion 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

CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Peking Union Medical College Hospital | N=43 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Anemia • Aplastic Anemia • Hematological Disorders

Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Peking Union Medical College Hospital | N=43 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Anemia • Aplastic Anemia • Hematological Disorders • Oncology

A prospective, single-arm, exploratory study on the efficacy and safety of romiplostim N01 for cancer treatment–induced thrombocytopenia in patients with gastrointestinal cancers. (ASCO 2026) - P=N/A | "Romiplostim N01 shows promising efficacy for CTIT in GI cancers, with most patients achieving rapid platelet recovery (median 7 days) and no need for transfusions. The manageable safety profile suggests it is a viable supportive care option. These findings will provide further support for its clinical use."

Clinical • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Musculoskeletal Pain • Oncology • Rectal Cancer • Solid Tumor • Thrombocytopenia

A phase II, single-arm study of romiplostim N01 for cancer treatment–induced thrombocytopenia in leukemia patients. (ASCO 2026) - P2 | "Preliminary findings suggest Romiplostim N01 may be effective in promoting platelet recovery with a manageable safety profile in leukemia patients with CTIT. Final results will provide further evidence for its clinical application."

Clinical • P2 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Oncology • Thrombocytopenia

Romiplostim-N01 for cancer therapy-induced thrombocytopenia: A propensity score-matched cohort study. (PubMed, Medicine (Baltimore)) - "Multivariate regression analysis confirmed that romiplostim-N01 was independently associated with an elevation in PLT count. These findings position romiplostim-N01 as a favorable alternative to rhIL-11 or rhTPO in CTIT, given its enhanced early PLT response and reduced risk of chemotherapy disruption."

Journal • Retrospective data • Hematological Disorders • Oncology • Solid Tumor • Thrombocytopenia

ITJ(QN)2510: A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia (clinicaltrials.gov) - P1 | N=280 | Not yet recruiting | Sponsor: Shanghai 10th People's Hospital

New P1 trial • Hematological Disorders • Infectious Disease • Septic Shock • Thrombocytopenia

N01-A-PICIT-GT: Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Peking University People's Hospital

New P2 trial • Breast Cancer • Cervical Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Hormone Receptor Positive Breast Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Thrombocytopenia

N01-A-PICIT-GI: Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Peking University People's Hospital

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia

Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia (clinicaltrials.gov) - P2 | N=43 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P2 trial • Anemia • Aplastic Anemia • Hematological Disorders • Oncology

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Initiation date: Jul 2025 ➔ Dec 2025 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Cholangiocarcinoma • Hematological Malignancies • Oncology • Pediatrics • Solid Tumor • Thrombocytopenia

Romiplostim N01 accelerates platelet engraftment in autologousstem cell transplantation using non-cryopreserved peripheral blood stem cells for plasma cell neoplasms. (PubMed, Front Immunol) - "Romiplostim N01 safely accelerates thrombopoietic recovery and substantially reduces cost when combined with non-cryopreserved PBSCs. This strategy represents a practical and economically favorable supportive-care model for ASCT."

Journal • Retrospective data • Amyloidosis • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Transplantation

CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA (clinicaltrials.gov) - P2 | N=43 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P2 trial • Anemia • Aplastic Anemia • Hematological Disorders