The EULAR conference of the international rheumatology and immunology community will be held in Vienna, the capital of Austria, from June 12th to June 15th, 2024. At the invitation of the conference, the VDJ-001 clinical research team orally reported the phase II clinical data of a new high affinity IL-6R monoclonal antibody (code: VDJ-001) compared head to head with tocilizumab in patients with active rheumatoid arthritis (RA) on the first day of the opening ceremony on June 12th. The report shows that this study has achieved the primary endpoint and key secondary endpoints. VDJ-001 is safe and effective for moderate to severe RA patients with poor response to methotrexate, and the proportion of ACR70 patients in the 6 mg/kg group of VDJ-001 is 33.3%, which exceeds the 30% of the positive control drug tocilizumab 8mg/kg group in the same study and is higher than the Phase III clinical history data of other marketed drugs, indicating the potential of VDJ-001 to become the best RA treatment drug in its class.

　　A total of 181 patients with moderate to severe active RA who had poor response to methotrexate were enrolled in this study. They were randomly and double-blindly divided into four study groups (VDJ-001 4mg/kg+MTX, 6mg/kg+MTX, MTX, and tocilizumab 8mg/k+MTX positive drug group) according to a 1:1:1:1 ratio, with head to head control and intravenous infusion once every four weeks. The main endpoint of the study was the proportion of subjects who met the American College of Rheumatology's 20% mild response standard (ACR20) at week 12 after three doses; The secondary endpoints of the study included the proportion of patients who achieved moderate response to ACR50 and high response to ACR70 at week 12, as well as the ongoing analysis of safety, pharmacokinetics, pharmacodynamics, and immunogenicity characteristics of VDJ-001. Currently, the ACR70 of drugs on the international market is relatively low, mostly at 20%. How to improve the ACR70 response rate for moderate to severe RA patients with poor response to methotrexate or DMARDS is a global challenge.

　　About VDJ-001

　　VDJ-001 is a recombinant humanized monoclonal antibody targeting IL-6R, developed based on the human B cell antibody evolution and screening technology platform with independent intellectual property rights. It is an original IL-6R innovative antibody drug in China and also an independently developed antibody drug for rare disease iMCD adaptation. It has received major government support such as the National Major New Drug Creation Project and the Beijing Municipal Science and Technology Commission's Major New Drug Creation. Its indications include rheumatoid arthritis, idiopathic Castleman's disease (iMCD), cytokine storm, immune related adverse reactions, inflammatory chronic kidney disease, chronic heart inflammation, etc. Its international patents have been approved in multiple countries such as China and the United States. At present, the project has completed phase II clinical trials for two indications, rheumatoid arthritis and rare disease iMCD, and is about to enter critical phase III clinical research.

　　Regarding the EULAR Conference

　　The EULAR Conference, also known as the European Alliance of Associations for Rheumatology, includes keynote speeches, seminars, poster displays, and covers various rheumatic diseases. It is an important international academic conference. The EULAR Conference is held once a year, where rheumatologists, researchers, doctors, and other healthcare professionals from around the world gather in the technology hall to share the latest research, clinical practice, and treatment progress, and enhance understanding and management of rheumatic diseases.

　　Regarding Weidejie Biotechnology:

　　Beijing VDJBio Co., LTD. focuses on innovative antibody drug development in the field of autoimmune diseases. With a unique antibody discovery and optimization platform, a complete platform for small, medium, and industrial production of large molecule drugs, we have developed a series of potential antibody/fusion protein drugs for the treatment of autoimmune diseases.