Sanofi's Quadrivalent Influenza Vaccine for 2025–2026 Season Receives Chinese Regulatory Approval and Re-enters Market with Stable Pricing

Recently, Sanofi China officially announced that itsTargeting2025-20The quadrivalent influenza virus split vaccine for the 26th flu season has officially received approval and release from the National Medical Products Administration.. In other words,Sanofi's Quadrivalent Influenza Vaccine to Re-enter China Market Soon

Influenza is an acute respiratory infectious disease caused by the influenza virus. Its antigenicity is highly variable, and it spreads rapidly, potentially leading to complications such as pneumonia, neurological damage, and shock, and in severe cases, even death. Relevant research analysis shows,The number of influenza cases in China each year is approximately84 million to 144 million, meaning that 1 in every 10 people will suffer from the flu.

According to the "Technical Guidelines for Influenza Vaccine Preventive Vaccination in China (2023-2024)》 shows that influenza vaccines approved for marketing in China includeTrivalent Inactivated Vaccine (IIV3), Trivalent Live Attenuated Vaccine (LAIV3)AndQuadrivalent Inactivated Vaccine (IIV4)Among them, IIV3 and IIV4 include split-virus vaccines and subunit vaccines. The guidelines recommend that everyone aged ≥6 months without contraindications should receive the influenza vaccine. However, for populations eligible to receive different types or brands of vaccine products, any influenza vaccine can be voluntarily chosen, with no preferential recommendation.

In August 2024, due to potency issues, Sanofi decided to temporarily halt the supply and sales of its influenza vaccine in China. SanofiYesOne of the world's largest suppliers of influenza vaccines,It currently hasTwo influenza vaccines launched in China are respectivelyTrivalent Influenza Vaccine (Split Virion) - Vaxigrip, Quadrivalent Influenza Vaccine (Split Virion) - VaxigripTetra. According to the product manual,Vaxigrip is suitable for adults andChildren over 36 months of age，Valganciclovir is suitable for individuals aged 6 months and above.。

According to public data,In 2022 and 2023, the global sales of Sanofi's influenza vaccine were 2.977 billion euros and 2.669 billion euros, respectively. In the first half of 2024, Sanofi accounted for 18% of the batch release of trivalent influenza vaccines and 15% of the batch release of quadrivalent influenza vaccines.As forIn China，Data shows,Sanofi's annual influenza vaccine doses remain basically stable atApproximately 10 million doses.

Now,Less than a year later, Sanofi announced that it had resolved the technical issues and confirmed the stability of the potency of the new batch of products.Resumption of Supply of Chinese Flu Vaccines，And reintroduce the quadrivalent influenza vaccine to the Chinese market.

According to Sanofi's statement to the Caixin Media:"In the process of producing influenza vaccines for the 2025-2026 flu season, we optimized the evaluation of immunogenicity and product stability.Completed the pilot production of the bulk solution in December 2024, followed by continuous research and testing. All results have demonstrated stable potency.”

In addition, according to a relevant person in charge of Sanofi, the company will properly ensure the production and supply of vaccines. The quadrivalent influenza vaccine produced in China adopts the same production quality control standards as the rest of the world, with some key materials imported from abroad.Considering factors such as exchange rates and production costs, Sanofi will not adjust the price of its influenza vaccine products.

According to information from the China Business Herald, based on previous information from the vaccine reservation platform,The price of Sanofi's quadrivalent influenza vaccine is inAround 138 RMB per vialWhen Sanofi had just announced the suspension of product supply, the reporter saw in the vaccine reservation system that the product had not been removed. In Beijing area, the price of Sanofi's quadrivalent influenza virus split vaccine (0.5ml/vial) was 153 to 248 yuan per vial.

It is worth noting that, because it is applicable toPeople aged 6 months and above, along with the brand recognition accumulated in the global market,Sanofi's Quadrivalent Vaccine Targets High-Payment-Willingness Population in First- and Second-Tier Cities, Forming a "Differentiated Competition" Situation with Chinese Vaccines。Its quadrivalent influenza vaccine has been resupplied, and presumably the subsequent threePrice Flu VaccineThe return is not far away.

Sanofi, as one of the top four vaccine companies globally,ItsThe vaccine pipeline mainly includes:1) Influenza; 2) Pertussis; 3) Meningitis; 4) RSV Vaccine, the overall global vaccine market has high entry barriers and a stable competitive landscape.，Therefore, the overall sales of vaccines remained stable.。

Among them, Sanofi's influenza vaccine product line currently includesTraditionalFluzon Inactivated Influenza Vaccine、New High-Dose Inactivated Flu Vaccine Fluzon (2009)、New Flublok Recombinant Influenza Vaccine (2017)According to QYResearch, the global influenza vaccine market size reached approximately USD 6 billion in 2023.It is expected to reach 12.36 billion US dollars by 2030., with a compound annual growth rate (CAGR) of 4.8% in the next few years.

In addition, according to SanofiThe 2025 Q1 quarterly report shows that, in terms of vaccines, Sanofi's recent highlights mainly include the Phase III clinical readout of the next-generation rabies vaccine SP0087, which is worth looking forward to.

References:

[1] Sanofi's Quadrivalent Influenza Vaccine for the 2025-2026 Flu Season Approved for Release in China. Sanofi China. June 13, 2025.

[2] Sanofi Returns to the Scene: Imported Quadrivalent Influenza Vaccine Approved for Marketing in China, Reigniting Competition in the Local Market. 21st Century Economic Report. June 13, 2025.

[3] @Everyone, This Type of Vaccine Has Dropped Significantly in Price! China Business Perspective. June 17, 2025.

[4] Sanofi Returns to Stir Up the Market! The Battle in China's Flu Vaccine Market Reignites. Cailian Press. June 16, 2025.

[5] French pharmaceutical giant - Sanofi Research (II). In-depth Value Investment Research Notes. October 18, 2024.

[6] [Medical Field Review] Update on Overseas Pharmaceutical Companies' Progress in Q1 2025: Sanofi SNY. Empty Guest. May 07, 2025.

[7] Sanofi financial report, etc.

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