Sanofi's Recombinant Quadrivalent Influenza Vaccine Supemtek® Approved in 31 European Countries for Adults Aged 18 and Older

• This is the world’s first and currently only approved recombinant quadrivalent vaccine indicated for adults aged 18 years and olderInfluenza Vaccine；

• Recombinant QuadrivalentInfluenza VaccineAntigen Content Is the StandardInfluenza Vaccinethree times;

• Compared with the standard quadrivalent vaccine based on chicken embryo technologyInfluenza VaccineIn comparison, the recombinant quadrivalent influenza vaccine further reduces the risk of influenza in adults aged 50 years and older by 30%.[1]，[2]。

Sanofi Pasteur’s Recombinant Quadrivalent Influenza Vaccine Receives Marketing Authorization from the European CommissionMarketed in the 27 EU Member States, as well as in the United Kingdom, Norway, Iceland, and Liechtensteinfor the prevention of influenza in adults aged 18 years and older. This next-generation influenza vaccine is the world’s first and currently only approved recombinant quadrivalent influenza vaccine. The vaccine was approved in Europe under the brand name Supemtek.®, previously approved in the United States under the trade nameFlublok Quadrivalent®。

Unlike traditional influenza vaccines produced in chicken embryos, recombinant quadrivalent influenza vaccines can avoid the risk of reduced vaccine strain match and decreased vaccine efficacy caused by adaptive mutations of the virus strains during production.to ensure precise genetic matching with the influenza vaccine production strains recommended annually by the World Health Organization (WHO).Additionally, the recombinant quadrivalent influenza vaccine contains three times the antigen dose.Compared with standard-dose quadrivalent influenza vaccine, recombinant quadrivalent influenza vaccine can further reduce by 30% in adults aged 50 years and older.[1]，[2]Risk of Influenza.

This EU approval is based on data from two Phase III randomized controlled trials, the results of which confirmed the efficacy of the next-generation recombinant quadrivalent influenza vaccine (Flublok Quadrivalent® /Supemtek®) safety, immunogenicity, and efficacy, with a total of more than 10,000 subjects enrolled[1]，[2]。

Furthermore, the effectiveness of recombinant quadrivalent influenza vaccine in the elderly population in Hong Kong has been strongly confirmed in clinical studies. ABenjamin John Cowling, Chair of the Department of Epidemiology and Biostatistics, School of Public Health, The University of Hong Kongstudies have shown: “By comparing the immunogenicity of recombinant quadrivalent influenza vaccine and standard quadrivalent influenza vaccine in the elderly population in Hong Kong,Recombinant quadrivalent influenza vaccine elicits higher post-vaccination antibody titers than standard-dose quadrivalent influenza vaccine, with a more pronounced immunogenicity advantage against the H3N2 subtype.[3]。”

Each year, the number of influenza-related deaths worldwide ranges from 290,000 to 650,000.[4]，[5]Between them, influenza-associated hospitalizations reached approximately 10 million.[6]. The latest data shows that,Within one week of influenza infection, the risk of acute myocardial infarction increases by up to 10-fold.StrokeRisk increased by up to 8-fold[7]—The disease burden it causes far exceeds the well-known respiratory complications of influenza.

Professor Zeng Guang, Member of the High-Level Expert Group of the National Health Commission and Former Chief Epidemiologist of the Chinese Center for Disease Control and PreventionBased on the conclusions drawn from relevant scientific literature, it is reiterated: “Compared to the World Health Organization's estimate of 5%-10% annually among adults globally[8]the influenza attack rate, the overall incidence of influenza in China is still underestimated."Under the new normal of COVID-19 prevention and control, special attention should be paid to strengthening influenza prevention and control to guard against potential 'COVID-19–influenza' dual outbreaks."

Zhang Heping, General Manager of Sanofi Pasteur Chinastated: “Following the U.S., Recombinant Quadrivalent Influenza Vaccine Gains ‘Pass’ for European Market, which is deeply encouraging. Currently, we are maintaining close communication and collaboration with various institutions,Strive to introduce the recombinant quadrivalent influenza vaccine as soon as possible“, fulfilling our firm commitment to advancing innovative technologies in influenza vaccines, and striving to bring this new generation of global influenza vaccine to the Chinese public at an early date.”

Sanofi Pasteur boasts the world’s most comprehensive portfolio of vaccines for the prevention of respiratory infectious diseases, supplying over 1 billion doses globally each year, including more than 200 million doses of influenza vaccine. One in every 2.5 influenza vaccines on the global market is supplied by Sanofi Pasteur. To address the pressures of the pandemic,During the 2020/2021 influenza season, Sanofi Pasteur increased its global influenza vaccine supply by 20%, reaching an unprecedented production volume of 250 million doses.and covering a broad portfolio of influenza vaccine products, providing immune protection for people of all age groups.