MIL62 / Beijing Mabworks Biotech - LARVOL DELTA

MIL62 Shows Increased Remission and Reduced Relapse Versus Cyclosporine A in MN (HCPLive) - "The 2-year, multicenter, randomized, open-label phase 3 trial evaluated whether adults with biopsy-proven MN achieved complete remission, defined as a urine protein-creatinine ratio (UPCR) <0.3 g/g with <15% decline in estimated glomerular filtration rate (eGFR) compared to standard-of-care cyclosporine A...By week 76, complete remission occurred in 49.4% of patients receiving MIL62 compared with 3.9% receiving cyclosporine A, an absolute difference of 46.5% (95% confidence interval [CI], 32.1-60.9; P <.0001; RR, 12.5; 95% CI, 4.0-39.0). At week 52, complete remission rates continued to favor MIL62 over cyclosporine A (37.7% vs 6.6%; P <.0001). Overall remission rates were consistently higher with MIL62 at weeks 24, 52, and 76 (all P <.001)."

P3 data • Nephrology

Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial (KIDNEY WEEK 2025) - P3 | "Conclusion MIL62 significantly improved remission rates, accelerated disease control, and preserved kidney function versus cyclosporine, with acceptable safety. These results support MIL62 as a promising therapeutic option for Primary MN."

Clinical • Late-breaking abstract • P3 data • Glomerulonephritis • Renal Disease

Updated NMOSD Diagnostic Criteria, Tavapadon NDA Submitted, MIL-62 Shows Promising Treatment Effects in NMOSD (NeurologyLive) - "Findings from a phase 3, randomized, double-blind, placebo-controlled trial (NCT05314010) showed that treatment with MIL62 (Mabworks Biotech), a glycoengineered type II anti-CD20 monoclonal antibody, led to low relapse risk and reduced disability progression in aquaporin-4 (AQP4)-IgG-positive neuromyelitis optica spectrum disorder (NMOSD). Over a 52-week treatment period, 4.4% of patients (2 of 25) randomized to MIL62 experienced a relapse compared with 45.7% (21 of 46) of those on placebo (HR, 0.069; 95% CI, 0.016-0.296; P <.001). In addition, investigators recorded an annualized relapse rate (ARR) of 0.092 in the MIL62 group vs 1.180 in the placebo cohort."

P3 data • Neuromyelitis Optica Spectrum Disorder

Type II Anti-CD20 Antibody MIL62 in AQP4-Positive Neuromyelitis Optica Spectrum Disorder: A Multicenter, Randomized, Double-Blind, Phase III Trial (ECTRIMS 2025) - P3 | "MIL62 significantly reduced relapse risk and disability progression in AQP4-IgG–positive NMOSD, with a favorable safety profile. Disclousure of interest: Dehui Huang: nothing to disclose. Lei Wu: nothing to disclose."

Clinical • Late-breaking abstract • P3 data • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis (clinicaltrials.gov) - P1/2 | N=41 | Active, not recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd.

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Jan 2026

Enrollment closed • Trial completion date • Glomerulonephritis • Renal Disease • EGFR

A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P1/2 | N=94 | Completed | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Apr 2025

Trial completion • Trial completion date • Glomerulonephritis • Renal Disease

Tianguangshi: Announcement on the acceptance of the new drug application for the core product MIL62 [Google translation] (Eastmoney.com) - "Recently, Beijing Tianguangshi Biotechnology Co., Ltd. (hereinafter referred to as the 'Company') received the 'Acceptance Notice' issued by the National Medical Products Administration (hereinafter referred to as the 'NMPA'). The company's new drug application (NDA) for the recombinant humanized monoclonal antibody MIL62 injection for the treatment of neuromyelitis optica spectrum disorder (NMOSD) was accepted by the NMPA. The relevant situation is now announced as follows: Basic information about drugs; Product Name: Recombinant humanized monoclonal antibody MIL62 injection; Specification: 200mg (8ml)/bottle; Acceptance number: CXSS2500054."

China filing • Neuromyelitis Optica Spectrum Disorder

A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Tianguangshi's MIL62 second indication reaches Phase III clinical milestone: treatment of neuromyelitis optica spectrum disorders successfully unblinded [Google translation] (Mabworks Press Release) - P3 | N=140 | NCT05314010 | Sponsor: Beijing Mabworks Biotech Co., Ltd. | "Recently, Beijing Tianguangshi Biotechnology Co., Ltd...announced that the Phase III clinical trial of its independently developed innovative third-generation CD20 antibody MIL62 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) reached the preset endpoint event number ahead of schedule and completed data unblinding. The preliminary analysis data of the primary endpoint obtained by the company showed that the time to first clinical relapse within 52 weeks or within 52 weeks in the Phase III clinical trial MIL62 treatment group was significantly better than that of the placebo group based on the evaluation of the Clinical Endpoint Committee (CEC), reaching the statistical superiority standard preset in the protocol and with good safety."

P3 data • Neuromyelitis Optica Spectrum Disorder

Type II Glycoengineered Anti-CD20 Antibody MIL62 or Cyclosporine in Chinese Primary Membranous Nephropathy: A Multicenter, Randomized, Open-Label Phase 1b/2 Trial (KIDNEY WEEK 2024) - P3 | "Background: A novel glycoengineered type II anti-CD20 antibody, MIL62 with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively. MIL62 was superior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months. A phase 3 clinical trial of MIL62 in pMN is ongoing (NCT05862233)."

Clinical • P1/2 data • Glomerulonephritis • Renal Disease

MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma (clinicaltrials.gov) - P3 | N=168 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology • CD20

A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Trial primary completion date: Nov 2024 ➔ Mar 2025

Trial primary completion date • Glomerulonephritis • Renal Disease

MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) (clinicaltrials.gov) - P1/2 | N=53 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Phase classification: P1b/2 ➔ P1/2 | Trial primary completion date: May 2024 ➔ Jan 2024

Phase classification • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial primary completion date • Glomerulonephritis • Renal Disease • EGFR

Recent Advances in the Treatment of Neuromyelitis Optica Spectrum Disorder (ANA 2024) - " A total of 18 clinical trials investigating 17 potential treatments for NMO which include 2 studies on BAT4406F and one study on each of the following: ublituximab, efgartigimod, divozilimab, orelautinib, ofatumumab, zanuutinib, daratumumab, TACI-antibody fusion protein injection (RC18),MIL62, ravulizumab, chimeric antigen receptor (CAR) T cell therapy, B001, edralutinib, baricitinib, belimumab and mitoxantrone. Since the etiology of NMO is multifactorial, inflammation, demyelination, and neuronal death should be considered while investigating new therapies to prevent relapse-related disability."

CNS Disorders

Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. (PubMed, EClinicalMedicine) - P1b/2, P3 | "MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively. Beijing Mabworks Biotech Co. Ltd, Beijing China and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015)."

Journal • P1/2 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Oncology • Thrombocytopenia

Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial (Lancet) - P1b/2 | N=53 | NCT04110301 | Sponsor: Beijing Mabworks Biotech Co., Ltd. | "This multicentre, single-arm, phase 1b/2 trial aimed to explore the efficacy, pharmacokinetics, and safety of MIL62 combined with lenalidomide in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL)....Disease control rate was 96% (48/50, 95% CI: 86, 100), proportion of patients with duration of response (DoR) > 6 months was 77% (33/43). The median follow-up for survival was 12.3 months (IQR 12.0–12.6). The 1-year progression-free survival rate was 72% (95% CI: 57, 83), 9-month DoR rate was 74% (95% CI: 58, 85), and 1-year overall survival rate was 98% (95% CI: 85, 100)."

P1/2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

The Type II Glycoengineered Anti-CD20 Antibody MIL62 or Cyclosporine in Chinese Primary Membranous Nephropathy: Updated Results of an Ongoing, Multicenter, Randomized, Open-Label Phase 1b/2 Trial (KIDNEY WEEK 2023) - P3 | "Background: A novel glycoengineered type II anti-CD20 antibody, MIL62 with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively. The 12-week iR and 24-week overall remmision of MIL62 was significantly higher than CsA , and had a manageable safety profile. A phase III clinical trial of MIL62 in pMN is ongoing (NCT05862233)."

Clinical • P1/2 data • Glomerulonephritis • Hematological Malignancies • Lymphoma • Oncology • Renal Disease

MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) (clinicaltrials.gov) - P1b/2 | N=53 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Trial completion date: May 2023 ➔ May 2025 | Trial primary completion date: Jan 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma (clinicaltrials.gov) - P3 | N=168 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology • CD20

A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Renal Disease • EGFR

A Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - P2/3 | N=200 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

THE TYPE Ⅱ ANTI-CD20 MONOCLONAL ANTIBODY MIL62 OR CYCLOSPORINE IN CHINESE PRIMARY MEMBRANOUS NEPHROPATHY: PRELIMINARY RESULTS OF A PHASE ⅠB/Ⅱ TRIAL (ERA-EDTA 2023) - P1/2 | "A novel glycoengineered type Ⅱ anti CD20 antibody, MIL62 with a nearly completely afucosylated N-glycans in Fc region, has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively. The 12-week immunological remission rate in the MIL62 group was significantly higher than the Cyclosporine group. MIL62 had a manageable safety profile. This phase Ib/II preliminary data warrant further phase III clinical trials of MIL62 in pMN."

Glomerulonephritis • Hematological Disorders • Renal Disease • Thrombocytopenia

A Clinical Study of MIL62 in Primary Membranous Nephropathy (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd.

New P3 trial • Glomerulonephritis • Renal Disease