Bejescin (obinutuzumab-β) / Beijing Mabworks Biotech, Everest Medicines - LARVOL DELTA

Efficacy and safety of obinutuzumab β, a novel glycoengineered type II anti-CD20 antibody, in patients with active systemic lupus erythematosus: results from a multicenter, randomized, double-blind, placebo-controlled phase 2 trial (ACR Convergence 2026) - No abstract available

Clinical • P2 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Chinese PLA General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • ANCA Vasculitis • Glomerulonephritis • Nephrology • Vasculitis

Obinutuzumab β for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial. (PubMed, Nat Med) - P3 | "In this multicenter, randomized, double-blind phase 3 trial, we evaluated obinutuzumab β (MIL62), a novel glycoengineered type II anti-CD20 monoclonal antibody, in patients with NMOSD. These findings support obinutuzumab β as a glycoengineered type II anti-CD20 therapeutic option for patients with AQP4-IgG+ NMOSD. ClinicalTrials.gov identifier: NCT05314010 ."

Clinical • Journal • P3 data • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Chinese PLA General Hospital

New P2 trial • ANCA Vasculitis • Glomerulonephritis • Nephrology • Vasculitis

Obinutuzumab β (MIL62), a Novel Glycoengineered Type II Anti-CD20 Antibody, for Active Lupus Nephritis: 104-Week Results of a Phase 1b/2 Randomized, Double-Blind, Placebo-Controlled Trial (EULAR 2026) - P1/2 | "Despite this, first- generation Type I anti-CD20 antibodies like rituximab failed to meet primary endpoints in the landmark EXPLORER and LUNAR trials [2,3]...Forty-one patients were randomized (4:1) to receive SOC (mycophenolate mofetil target dose 1.0–1.5 g/d and tapered glucocorticoids) plus either obinutuzumab β or placebo...Conclusions Obinutuzumab β 1000 mg Q6M combined with SOC demonstrated a sustained trend toward higher renal response rates through 104 weeks in active LN. The treatment was well-tolerated with a manageable safety profile, supporting further clinical investigation."

Clinical • P1/2 data • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Novel Coronavirus Disease

Everest Medicines has obtained exclusive rights for the clinical development and commercialization of Bejescin (MIL62, Obinutuzumab beta Injection) across the Asia-Pacific region, including Southeast Asia, India, South Korea, Australia, New Zealand, Hong Kong SAR, Macao SAR, and Taiwan region, China. (Yahoo Finance) - "Under the terms of the agreement, Everest Medicines will pay Mabworks an upfront payment of RMB 23 million and sales milestone payments of up to RMB 186 million. Mabworks will also be eligible to receive a share of gross profit in the region."

Licensing / partnership • Follicular Lymphoma • Nephrology • Neuromyelitis Optica Spectrum Disorder • Systemic Lupus Erythematosus

Safety and Efficacy of Obinutuzumab β (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial. (PubMed, Neurol Ther) - P3 | "Obinutuzumab β demonstrated manageable safety and may have promising efficacy against NMOSD. Despite the lack of a comparator group, the results support evaluation in phase III trials."

Journal • P1 data • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

COST EFFECTIVENESS ANALYSIS OF OBINUTUZUMAB? VERSUS CYCLOSPORINE A IN THE TREATMENT OF PRIMARY MEMBRANOUS NEPHROPATHY (ISPOR 2026) - "Obinutuzumab β offers improved efficacy and cost savings for PMN compared to CsA. Given the high unmet need in PMN management and the economic burden of current therapies, Obinutuzumab β represents a valuable addition to the treatment landscape."

Cost effectiveness • HEOR • Glomerulonephritis • Nephrology • Renal Disease

A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=316 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Impact of afucosylation strategy on antibody function: a comparative study of glycoengineered anti-CD20 antibodies Obinutuzumab and Obinutuzumab beta. (PubMed, MAbs) - "These structural differences not only fine-tune ADCC potency, but also impact antibody stability. Particularly, complete afucosylation of MIL62 led to optimized ADCC potency and effectively suppressed pathogenic B cells repopulation in a delta-like ligand 3 (DLL3) re-challenge model, providing a critical framework for designing next-generation antibodies with superior therapeutic efficacy."

Clinical • Journal • Immunology • DLL3

A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd.

New P3 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting | Phase classification: P2/3 ➔ P2 | N=200 ➔ 120

Enrollment change • Enrollment closed • IO biomarker • Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

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