The 67th American Society of Hematology (ASH) Annual Meeting was grandly held from December 6 to 9, 2025, in Orlando, USA. As the most influential annual event in the global field of hematology, ASH brings together over 30,000 top scholars, clinical experts, and researchers from more than 100 countries each year to share cutting-edge academic achievements, groundbreaking clinical research, innovative diagnostic and treatment concepts, and valuable practical experiences. Professor Lu Zhang, Chief Physician of the Department of Hematology at Peking Union Medical College Hospital, representing the team of Professor Jian Li, Professor Yujun Dong, and Professor Liangming Ma, was invited to present the Phase II research data of VDJ-001 for the treatment of idiopathic multicentric Castleman disease (iMCD) at the conference (Abstract No.: Presentation 4787).

The study has met both its primary and key secondary endpoints. Data from a median treatment period exceeding 20 cycles show that VDJ-001 demonstrated favorable safety and efficacy in iMCD patients, with 96% of patients achieving long-term benefits. Some participants have already entered an extension phase lasting up to the fourth year.

iMCD is a rare hematologic disease that threatens patients' lives, health, and quality of life. It has been included in China's First List of Rare Diseases. Currently, the remission rates of internationally available drugs are relatively low, and the response rate in previous prospective clinical studies has been approximately 34%. Improving the treatment standards for this rare disease is a challenge faced by physicians and patients worldwide dedicated to this field. To address this challenge, this study enrolled 25 iMCD patients, who were assigned to five groups according to the protocol: VDJ-001 at 4 mg/kg, 6 mg/kg, or 8 mg/kg administered once every two weeks, or 4 mg/kg and 6 mg/kg administered once every three weeks via intravenous infusion. The primary endpoint was the safety and tolerability after three doses, while secondary endpoints included the proportion of patients meeting the international response criteria (CDCN 2018) at week 12, as well as pharmacokinetic, pharmacodynamic, and immunogenicity analyses of VDJ-001. To date, among the 25 patients enrolled in the study, except for one who discontinued treatment due to inadequate efficacy, the remaining 24 patients (96%) have achieved long-term benefits from VDJ-001 treatment and continue to use the drug. Throughout the study, the drug exhibited a favorable safety profile, with no treatment discontinuations due to safety concerns.

About VDJ-001

VDJ-001 is a proprietary recombinant humanized monoclonal antibody targeting IL-6R. Developed based on a human B-cell antibody evolution and screening technology platform, it is an original innovative IL-6R antibody drug in China and the first domestically developed antibody drug to undergo clinical research for the rare disease indication of iMCD. It has received key governmental support, including the National Major New Drug Innovation Project and the Beijing Municipal Science and Technology Commission Major New Drug Innovation Project. Its indications cover rheumatoid arthritis, idiopathic multicentric Castleman disease (iMCD), cytokine storms, immune-related adverse reactions, inflammatory chronic kidney disease, chronic cardiac inflammation, and more. International patents for VDJ-001 have been granted in multiple countries, including China and the United States. Currently, VDJ-001 has completed Phase II clinical trials for both rheumatoid arthritis and iMCD indications and has advanced to pivotal Phase III studies.

About Weidejie Biotech

Beijing VDJBio Co., LTD. focuses on the development of innovative antibody drugs for autoimmune diseases. Leveraging a unique antibody discovery and optimization platform, as well as a comprehensive small-scale, pilot-scale, and industrial-scale production system for macromolecular drugs, the company has developed a series of promising therapeutic antibodies and fusion protein drugs for autoimmune diseases.