tocilizumab biobetter (VDJ001) / VDJBio - LARVOL DELTA

An open-label Phase II trial of VDJ-001, a high-affinity IL-6R antagonist antibody, for the treatment of patients with idiopathic multicentric castleman disease (ASH 2025) - P2 | "Although siltuximab has been approved in manycountries, this first IL-6 blocking antibody only revealed a beneficial effect for 34% of patients with iMCD.To explore more effective therapy, a novel IL-6R antagonizing antibody (VDJ-001) with high-affinity andpotent activities has been assessed for safety and efficacy in this open-label phase II trial.A total of 25 Chinese iMCD patients with active disease were enrolled in this open-label, multi-center,dose-escalation and regimen study from April 2022 to September 2024; and their treatment responsesand safety profiles after VDJ-001 treatment were monitored up to June 18th, 2025 (last follow-up date)...The PK analysis indicated a different Cminprofile between two doses, [i.e., the median (range) of Cmin by Cycle 4 was 3.04 μg/mL(undetectable~14.4) for 4mg/kg group and 9.66 μg/mL (5.05~16.7) for 6mg/kg group respectively,] andonly 6 mg/kg dose met/exceeded the steady-state requirement of minimal concentration (Cmin)..."

Clinical • P2 data • Dyslipidemia • Eosinophilia • Hematological Disorders • Hypertriglyceridemia • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Rare Diseases • IL6R

VDJ001-RA-Ⅲ: Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=615 | Enrolling by invitation | Sponsor: Beijing VDJBio Co., LTD. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of Anti-IL-6R mAb Injection in Patients With iMCD (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Beijing VDJBio Co., LTD. | Recruiting ➔ Active, not recruiting

Enrollment closed • Rare Diseases • IL6R

VDJ001-RA-Ⅲ: Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=615 | Not yet recruiting | Sponsor: Beijing VDJBio Co., LTD. | Initiation date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Phase III Trial of VDJ001 in Patients with Moderate-to-severe Active Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=615 | Not yet recruiting | Sponsor: Beijing VDJBio Co., LTD.

New P3 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND-TOCILIZUMAB CONTROLLED PHASE II TRIAL OF VDJ-001, A HIGH-AFFINITY IL-6R ANTAGONIST ANTIBODY, FOR THE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS (EULAR 2024) - P2 | " In this double-blind, placebo and positive drug-controlled phase II study, 180 adult patients with moderate-to-severe active rheumatoid arthritis who had inadequate response to methotrexate (MTX) were randomly assigned to 4-treatment arms in 1:1:1:1 ratio, i.e., 4 mg/kg and 6 mg/kg of VDJ-001, 8 mg/kg of Tocilizumab, or placebo, i.v. q4w... VDJ-001 is safe and effective in patients with rheumatoid arthritis. Its higher affinity and higher biological activity seem to be associated with the tendency of higher efficacy. The highly competitive rate (33.3%) on ACR70 response makes VDJ-001 6 mg/kg one of the best treatment options for RA patients."

Clinical • P2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology • IL6R

Tolerability, safety, and pharmacokinetics of a single intravenous administration of a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody in healthy Chinese volunteers. (PubMed, Front Pharmacol) - "As an analog of tocilizumab, it exhibited improved affinity and in vitro activity... The safety and tolerability of VDJ001 are acceptable with a single intravenous dosage of 1∼8 mg/kg. Further clinical trials are warranted."

Clinical • Journal • PK/PD data • IL6R

A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial

A Study of Anti-IL-6R mAb Injection in Patients With iMCD (clinicaltrials.gov) - P2 | N=9 | Recruiting | Sponsor: Beijing VDJBio Co., LTD. | Trial completion date: Feb 2023 ➔ Dec 2024

Trial completion date • Rare Diseases • CRP • IL6 • IL6R

A PROSPECTIVE TRIAL OF A NOVEL RECOMBINANT HUMANIZEDANTI-INTERLEUKIN-6 RECEPTOR MONOCLONAL ANTIBODY INJECTION(VDJ001) IN IDIOPATHIC MULTICENTRIC CASTLEMAN DISEASE: THE PRELIMINARY RESULTS (EHA 2023) - "However, the effective rate of siltuximab, the mostly widely used IL-6 targeted therapy for iMCD, was not satisfactory (34% in clinical trial). VDJ001, a novel recombinant humanized anti-IL-6R mAb, showed excellent safety and efficacy profiles in iMCD patients. Figure 1. Treatment response of iMCD patients after VDJ001 treatment."

Clinical • Eosinophilia • Hematological Disorders • Neutropenia • Rare Diseases • IL6R

A Study of Anti-IL-6R mAb Injection in Patients With iMCD (clinicaltrials.gov) - P2 | N=9 | Recruiting | Sponsor: Beijing VDJBio Co., LTD.

New P2 trial • Rare Diseases • CRP • IL6 • IL6R