Anpingxi (ripertamab) / Sinocelltech, CSPC Pharma - LARVOL DELTA

EFFICACY AND SAFETY OF A NOVEL ANTI-CD20 AGENT RIPERTAMAB IN TREATMENT OF PRIMARY MEMBRANOUS NEPHROPATHY : A MULTI-CENTER, RETROSPECTIVE STUDY IN CHINA (ERA 2025) - No abstract available

Retrospective data • Glomerulonephritis • Renal Disease

The efficacy and safety of ripertamab in inducing remission of primary membranous nephropathy: a retrospective study (ERA 2025) - No abstract available

Retrospective data • Glomerulonephritis • Renal Disease

Efficacy and safety of ripertamab for treating primary membranous nephropathy among adults: a multicenter, retrospective, real-world study. (PubMed, Front Immunol) - "Ripertamab demonstrated efficacy and good tolerability for the treatment of PMN in a Chinese real-world setting. These findings support the use of ripertamab as a therapeutic option for PMN patients and suggest the need for further investigation into its long-term safety and efficacy."

Journal • Real-world evidence • Retrospective data • Glomerulonephritis • Renal Disease

RIPERT-CIDP: Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (clinicaltrials.gov) - P3 | N=175 | Not yet recruiting | Sponsor: Zhongming Qiu

New P3 trial • Pain

RPE-ITP: Ripertamab Plus Eltrombopag vs. Eltrombopag in ITP Patients Post-Steroid Failure (clinicaltrials.gov) - P=N/A | N=78 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Effectiveness and Safety of Ripertamab in the Treatment of Primary Membranous Nephropathy: A Retrospective Study (ChiCTR) - P=N/A | N=20 | Recruiting | Sponsor: Department of Nephrology, Zhongshan Hospital of Xiamen University; Zhongshan Hospital of Xiamen University

New trial • Glomerulonephritis • Renal Disease • CD19 • CD20

PC-002 (Sepantronium Bromide) Enhances the Antitumor Efficacy of Anti-CD20 Antibody By CD20 Upregulation (ASH 2024) - "P493 tet-off cells were treated with tetracycline to suppress the expression of c-Myc (Myc-off)...Furthermore, mouse xenografts (RAMOS, SU-DHL-4, SU-DHL-10 and OCI-LY7) were established to evaluate the efficacy of YM155 (2 mg/kg, 168-hour-infusion) in combination with anti-CD20 antibody, including Rituximab, Ripertamab and Ofatumumab in vivo...Moreover, the up-regulation of CD20 after PC-002 treatment in RFP/Luc cells was confirmed by whole transcriptome analysis. These results indicate that PC-002 enhances the efficacy of anti-CD20 antibody by downregulating c-Myc, and support the planned clinical investigation of the combination of PC002 with an anti-CD20 antibody such as rituximab in patients with relapsed/refractory c-Myc driven Burkitt lymphoma or diffuse large B-cell lymphoma.Conclusion : In conclusion, our preclinical data highlight the potent anti-tumor effects of PC-002 in combination with anti-CD20 antibody in patients with DLBCL and BL, and warrant the planned..."

Clinical • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Orthopedics • Solid Tumor • Targeted Protein Degradation • MYC • USP7

Efficacy and Safety of a NOVEL ANTI-CD20 Agent (SCT400) in CD20-Positive B-NHL: A Retrospective, Realworld Study in Chongqing, China (ASH 2024) - "The outcomes indicate that SCT400 could potentially replace rituximab in medical practice. Nonetheless, to solidify these findings, additional research with an expanded patient group is essential."

Real-world • Real-world evidence • Retrospective data • Anemia • B Cell Lymphoma • Bone Marrow Transplantation • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Febrile Neutropenia • Follicular Lymphoma • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Small Lymphocytic Lymphoma • Thrombocytopenia

A Novel Anti-CD20 Monoclonal Antibody for Treating Relapsed Immune Thrombocytopenia (ASH 2024) - "Background and Objective : The anti-CD20 monoclonal antibody, such as rituximab, is a guideline-recommended reagent for refractory/relapsed immune thrombocytopenia (ITP) treatment...Four patients (28.6%) had previously received treatment with two medications, while ten patients (71.4%) had been treated with three or more different medications, including immunoglobulins, all-trans retinoic acid (ATRA), cyclosporine, sirolimus, and thrombopoietin receptor agonists (TPO-RAs), etc. Before Ripertamab treatment, the average platelet count was 20×109/L...During the follow-up period, a total of 4 patients relapsed, with three of them occurring in the third month after the initial treatment and one in the first month after the initial treatment. Adverse events included an infusion-related reaction (fever in 14.2% of patients) during the first dose and an upper respiratory tract infection (7.1%).Conclusion : Ripertamab can effectively induce remission of relapsed ITP and..."

B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Thrombocytopenic Purpura • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Thrombocytopenia • Thrombocytopenic Purpura

Efficacy and Safety of Ripertamab With or Without Other Drugs in B-cell Non-Hodgkin's Lymphomas (ChiCTR) - P=N/A | N=400 | Recruiting | Sponsor: Institute of Hematology and Oncology, Harbin The First Hospital; Institute of Hematology and Oncology, Harbin The First Hospital

New trial • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

EFFICACY AND SAFETY OF A NOVEL ANTI-CD20 AGENT "RIPERTAMAB (SCT400)" -BASED CHEMOTHERAPY IN PATIENTS WITH CD20-POSITIVE B-NHL: A MULTI-CENTER, RETROSPECTIVE, REAL-WORLD STUDY IN CHINA (EHA 2024) - "Our study's real-world findings offer preliminary evidence of the efficacy and safety of Ripertamab, a rituximabalternative, in the treatment of B-NHL among the Chinese population. These results suggest that Ripertamabmay serve as a viable substitute for rituximab in clinical settings. However, to reinforce the validity of ourconclusions, further investigation involving a larger cohort is warranted."

Real-world • Real-world evidence • Retrospective data • Anemia • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Fatigue • Febrile Neutropenia • Infectious Disease • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma

Efficacy and safety of Ripertamab in paediatic glomerular disease (ERA-EDTA 2024) - "Ripertamab as a novel anti-CD20 monoclonal antibody developed by China, has been structurally optimized to specifically bind to the transmembrane antigen CD20, with an amino acid difference in the constant region sequence compared to rituximab. This study suggests that ripertamab could be an effective and safe treatment for various pediatric glomerular diseases."

Clinical • ANCA Vasculitis • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Vasculitis

The efficacy and safety of ripertamab (SCT400) in the treatment of primary membranous nephropathy: a single center retrospective study (ERA-EDTA 2024) - "Ripertamab, a novel anti-CD20 monoclonal antibody developed in China, has been shown to be non-inferior to rituximab in efficacy and safety in patients with B-cell non Hodgkin's lymphoma. Ripertamab can effectively induce remission of PMN and have a favorable safety profile."

Retrospective data • Glomerulonephritis • Hematological Malignancies • Hepatology • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Disease • Solid Tumor • Systemic Lupus Erythematosus

Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD (clinicaltrials.gov) - P3 | N=81 | Not yet recruiting | Sponsor: Air Force Military Medical University, China

Combination therapy • New P3 trial • Glomerulonephritis

A multi-center, open-label, randomized, parallel-controlled phase II study comparing pharmacokinetic, pharmacodynamics and safety of ripertamab (SCT400) to rituximab (MabThera) in patients with CD20-positive B-cell non-Hodgkin lymphoma. (PubMed, Chin J Cancer Res) - "The incidences of treatment-emergent adverse events and treatment-related adverse events were also comparable between the two groups. In this study, the PK, PD, immunogenicity, and safety profile of ripertamab (SCT400) were similar to rituximab (MabThera) in Chinese patients with CD20-positive B-cell NHL."

Journal • P2 data • PK/PD data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Efficacy and Safety of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody (SCT400) Combined with CHOP in Patients with Treatment-Naïve Diffuse Large B-Cell Lymphoma: A Multicenter, Randomized, Single-Blind, Parallel Active-Controlled, Phase III Study (ASH 2021) - P3 | "Objectives: This phase III study aimed to evaluate the safety and efficacy of SCT400 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) compared with rituximab plus CHOP in patients with treatment-naïve diffuse large B-cell lymphoma (DLBCL) (ClinicalTrials.gov, identifier: NCT02772822). SCT400 plus CHOP showed non-inferiority of efficacy to rituximab plus CHOP in patients with treatment-naïve DLBCL. The safety and immunogenicity profiles of SCT400 were comparable with rituximab, with no new treatment-related AE occurred. SCT400 could be a therapeutic option for DLBCL."

P3 data • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb (Bioworld) - "Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile."

Non-US regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Comparison of Efficacy and Safety of Ripertamab (SCT400) Versus Rituximab (Mabthera ) in combination with CHOP in Patients with Previously Untreated CD20-positive Diffuse Large B-cell Lymphoma: A Randomized, Single-blind, Phase III Clinical Trial. (PubMed, Hematol Oncol) - "This study demonstrated that S-CHOP was not inferior to R-CHOP in the first-line treatment of CD20-positive DLBCL Chinese patients in efficacy, safety and immunogenecity. S-CHOP could be an alternative first-line treatment for DLBCL, and was expected to be a cost-effective alternative to rituximab and offer an opportunity to increase access to the biologics."

Combination therapy • Journal • P3 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Shenzhou Cell: SCT800 and SCT400 marketing authorization applications are still under review [Google translation] (Finet Group) - "...Shenzhou Cell (688520) said in response to investors’ questions on the interactive platform that the company submitted applications for marketing authorization for SCT800 (recombinant eight factors) and SCT400 (CD20 antibody) at the end of 2019, and is still under review During the approval process. Shenzhou Cell stated that there is not necessarily a clear time relationship between the production license of the drug and the product marketing license."

Non-US regulatory • Hemophilia • Oncology