Drug name
Last update: Sep 2026Clulevibart (RB0026)
Developer(s)
Drug information
RB-0026 ; 库莱韦拜单抗 ; Clulevibart
investigational
Biotherapeutic
Monoclonal antibody - Respiratory syncytial virus F protein inhibitor
RB0026 appears to be a fully human, long-acting anti-RSV monoclonal antibody targeting the RSV F protein, currently being developed by ReYoung (Suzhou) Biology Science & Technology Co., Ltd. for prevention of RSV disease in infants. RB0026's binding targets are likely RSV sites II and IV (compared to site 0 preF for nirsevimab and site IV preF and postF for clesrovimab)
A marketing authorization application has reportedly been accepted by China's NMPA/CDE and granted priority review.
Submitted to NMPA
Therapeutic area(s)
- Respiratory syncytial virus (RSV)
- Prevention
Administration route
Intramuscular
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- To be determined
- Once
Dosage
to be determined
to be determined
to be determined
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Related entries
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Additional information
Developer(s)
ReYoung
ReYoung Biology Science & Technology Co., Ltd.
Drug structure
Scale-up and manufacturing prospects
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Excipients & delivery device(s)
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Safety, Efficacy and Evidence Summary
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Clulevibart - Full human antibody against respiratory syncytial virus
Disclosed are an antibody (preferably a fully human antibody R66) against respiratory syncytical virus RSV, encoding nucleic acids thereof, a vetor and a host cell comprising the same, and a preparation method thereof. Disclosed are also a use of the antibody (preferably a fully human antibody R66) against RSV in the prevention and treatment of RSV-related diseases, and a use of the same in detecting TSV. The above antibody against RSV is preferably a fully human monoclonal antibody. Compared with other animal-derived (e.g., murine) anti-RSV antidodies, the immunogenicity caused by species differences is greatly reduced. With good specificity and affinity, if used for clinic, it will greatly reduce side effects.
WO2017092645
Compound
Eliteimmune Inc.
Not provided
November 29, 2036
Granted in China, Japan, Australia, the United States, South Korea and patent application is pending in Europe.