Nirsevimab (Beyfortus): First Long-Acting Monoclonal Antibody Approved in China for RSV Prevention in All Infants
AstraZeneca
Biopharmaceutical Manufacturer
Sanofi
Pharmaceutical R&D Developer
Beyfortus (Nirsevimab), a single-dose long-acting antibody jointly developed by AstraZeneca and Sanofi, was approved in the EU on November 3, 2022, for the prevention of RSV-induced lower respiratory tract disease in newborns and infants during their first RSV season.
On November 7, 2022, Nirsevimab was approved in the UK for the prevention of RSV-induced lower respiratory tract disease in newborns and infants during their first RSV season.
On July 18, 2023, the U.S. FDA approved Nirsevimab for the prevention of lower respiratory tract disease caused by RSV in neonates and infants entering or born during their first RSV season, as well as in children up to 24 months of age who remain at high risk for severe RSV disease during their second RSV season.
On January 2, 2024, AstraZeneca and Sanofi jointly announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab) has officially been approved for marketing by the China National Medical Products Administration (NMPA) to prevent lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in newborns and infants. The drug is suitable for newborns and infants who are about to enter or be born during their first RSV infection season. Nirsevimab is expected to be used in China during the 2024-2025 RSV infection season.
Nirsevimab (Nirsevimab/MEDI8897) is a fully human recombinant IgG1κ monoclonal antibody targeting the prefusion conformation (pre-F) of the RSV F protein. By introducing three M252Y/S254T/T256E (YTE) mutations in the Fc fragment, it reduces antibody degradation and extends the half-life to 63-73 days. A single dose provides protection for up to five months and is used to prevent RSV-related LRTI in all infants. Nirsevimab provides passive immunity by binding to a highly conserved epitope Φ on the prefusion site of the RSV F protein (different from the binding site site Ⅱ of Palivizumab), thereby inhibiting the membrane fusion step necessary for viral entry.
In terms of immunization methods: The long-acting antibody Beyfortus is a "passive immunization" approach, which does not require the involvement of the human immune system. This antibody is directly delivered into the bloodstream, where it binds to pathogens, preventing the virus from infecting healthy cells.
In terms of onset time: Compared with vaccines, Beyfortus provides highly effective protection immediately after use, while vaccines often take 1-2 weeks to produce the corresponding antibodies.
In terms of the applicable population: Many infants have an immune system that is not yet fully matured shortly after birth, making it difficult to achieve comprehensive protection through direct vaccination. "Passive immunity" may be a more direct and effective method, and the respiratory syncytial virus is one of the leading pathogens causing lower respiratory tract infections in infants and young children.
Palivizumab, a product of AstraZeneca, is a humanized monoclonal antibody. It targets antigenic epitope II of the Pre-F fusion protein and was approved by the FDA for marketing in 1998.
Clesrovimab from Merck & Co., targeting the Pre-F IV epitope, is currently in Phase III clinical trials.
Rilematovir (JNJ-53718678) from Janssen can specifically target and bind to the fusion protein F on the virus surface, inhibiting RSV fusion protein-mediated fusion with the host cell membrane and preventing viral entry.
Sanofi's nanobody platform is also developing RSV nanobodies (ALX 0171).
Regeneron's Suptavumab Fails in Phase III Clinical Trial, Development Halted.
The conformation of the RSV F protein is crucial for the development and evaluation of vaccines and antiviral drugs. The Pre-F form can induce more effective neutralizing antibodies, while the Post-F form can be used as a control when screening for Pre-F specific antibodies.ACROBiosystems Baipusaishisi supports RSV-related research and vaccine development by launchingRSV Strain B1/A2 with specially designed trimeric pre-fusion conformationPre-F, After FusionPost-FAndG protein；RSV-F Broad-Spectrum Antibodies and Pre-F & Post-F Specific Antibodies (Including Paired Antibodies)、Pre-F/Post-F Antigen and Antibody Detection Kitetc.RSV Vaccine Development Comprehensive Solution！
Human/Mouse/Cotton Rat/Monkey Anti-Pre-F Antibody Detection Kit, welcome to click and view!
✔ Specially Designed Natural Conformation:Pre-F protein in its native trimeric conformation before fusion, Post-F protein after fusion, and G protein
✔Rich product types:Covering the correct conformation of RSV Pre-F, Post-F, and G proteins, RSV-F0 broad-spectrum antibodies and Pre-F specific antibodies, Pre-F, Post-F antigens, and antibody detection kits;
✔High Purity:Purity >90% as verified by SDS-PAGE and SEC-MALS;
✔High Activity:The strong binding ability of Pre-F and Post-F proteins with their specific antibodies was verified by ELISA.
✔High Immunogenicity:Natural conformation RSV-F and G proteins can induce higher antibody titers.
● SEC-MALS
Pre-F trimer protein purity >90% as verified by SEC-MALS
The purity of HRSV (A) Fusion glycoprotein F0, His Tag (Cat. No. RSF-V52H7) is more than 90% and the molecular weight of this protein is around 175-200 kDa verified by SEC-MALS.
● ELISA
As verified by ELISA, HRSV (A) Fusion glycoprotein F0 binds to 12C6, while Post-Fusion glycoprotein F0 does not bind to it, consistent with the reported binding of antibody D25 in the literature.
Immobilized HRSV (A) Pre-fusion glycoprotein F0, His Tag (Cat. No. RSF-V52H7) at 1 μg/mL (100 μL/well) can bind Monoclonal Anti-RSV-Pre-F0 specific Antibody, Human IgG1 (12C6) (Cat. No. RS0-S286)/Anti-Fusion glycoprotein F0 Antibody, Human IgG1 (D25) with a linear range of 0.1-2 ng/mL. HRSV (A) Post-fusion glycoprotein F0, His Tag (Cat. No. RSF-V52H6) is verified not recoginized by Monoclonal Anti-RSV-Pre-F0 specific Antibody, Human IgG1 (12C6) (Cat. No. RS0-S286)/Anti-Fusion glycoprotein F0 Antibody, Human IgG1 (D25) in low concentration (Routinely tested).
Correct（RAS-T161）The method validation was performed for the kit MRD, cutoff value, specificity, linearity and linear range, precision and accuracy, and robustness.
● Precision
The method validation of this kit included MRD, cutoff value, specificity, linearity and linear range, precision and accuracy, and robustness.
a. Within-batch precision:Seven samples were tested 10 times within a batch to evaluate the intra-batch precision.
b. Between-batch precision:Seven samples were tested three times in inter-batch repeatability to evaluate the precision between batches.
The intra-assay coefficient of variation (CV < 10%) and inter-assay coefficient of variation (CV < 10%) of this project have been verified to meet the standard range declared by the kit, satisfying laboratory requirements and can be used for routine project testing.
● Accuracy
Set three quality control point concentrations, each repeated 10 times, with recovery rates all within the 80-120% range.
● Typical Data
Scan the QR code to get the RSV comprehensive solution manual, more validation data awaits your review!
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