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Drug information

Drug's link(s)
Generic name

RB-0026 ; 库莱韦拜单抗

Brand names

investigational

Compound type

Biotherapeutic

Drug class/category

Monoclonal antibody - Respiratory syncytial virus F protein inhibitor

Summary

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)

Approval status

A marketing authorization application has reportedly been accepted by China's NMPA/CDE and granted priority review.

Regulatory authorities

Submitted to NMPA

Therapeutic area(s)

  • Respiratory syncytial virus (RSV)
Use case(s)
  • Prevention

Administration route

Intramuscular

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Use of drug

Ease of administration
  • To be determined
Frequency of administration
  • Once
User acceptance
Not provided

Dosage

Available dose and strength

to be determined

Maximum dose

to be determined

Recommended dosing regimen

to be determined

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

ReYoung
Originator
China

ReYoung

ReYoung (Suzhou) Biology Science & Technology Co., Ltd.

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

Not provided

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL