Nirsevimab is a Monoclonal Antibody owned by AstraZeneca, and is involved in 7 clinical trials, of which 3 were completed, and 4 are ongoing.

Nirsevimab (MEDI-8897, SP-0232) is an RSV mAb. It acts by neutralizing the RSV-F protein. The antibody D25 binds to the RSV F protein prefusion complex. The cocrystal structure for one of these antibodies, D25, in complex with the F glycoprotein revealed D25 to lock F in its prefusion state by binding to a quaternary epitope at the trimer apex. They recognize a prefusion complex of the RSV-F protein. By targeting the RSV-F protein in the compact prefusion conformation, these antibodies could halt the critical unfolding of this protein into the conformation required for viral entry into cells.

The revenue for Nirsevimab is expected to reach a total of $17.8bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Nirsevimab NPV Report.

Nirsevimab was originated by AIMM Therapeutics and is currently owned by AstraZeneca. Sanofi and Swedish Orphan Biovitrum are the other companies associated in development or marketing of Nirsevimab.

Nirsevimab Overview

Nirsevimab (Beyfortus) is a human recombinant monoclonal antibody. It is formulated as a solution for the intramuscular route of administration. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.

Nirsevimab (MEDI-8897, SP-0232) is under development for the prevention of lower respiratory tract disease caused by respiratory syncytial virus infection in infants. It is administered intramuscularly as a solution. It is a D25 RSV-specific antibody and it is engineered with a triple-amino-acid (M252Y/S254T/T256E [YTE]) substitution within its Fc region. These antibodies are specific for the RSV-F protein. It is based on AIMSelect And AIMProve technology.

Sanofi Overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

The company reported revenues of (Euro) EUR39,175 million for the fiscal year ended December 2021 (FY2021), an increase of 4.8% over FY2020. In FY2021, the company’s operating margin was 20.7%, compared to an operating margin of 37.8% in FY2020. In FY2021, the company recorded a net margin of 15.9%, compared to a net margin of 32.9% in FY2020. The company reported revenues of EUR13,138 million for the third quarter ended September 2022, a decrease of 36.8% over the previous quarter.

Quick View – Nirsevimab

Report Segments
  • Innovator (NME)
Drug Name
  • Nirsevimab
Administration Pathway
  • Intramuscular
Therapeutic Areas
  • Infectious Disease
Key Companies
  • Sponsor Company: AstraZeneca
  • Originator: AIMM Therapeutics
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.