Recently, the news of the suspension of the Pasteur flu vaccine under the vaccine giant Sanofi has attracted widespread market attention.
On the afternoon of August 27th, a reporter from Shanghai Securities News consulted Sanofi China as a consumer. The company stated that due to efficacy issues, Sanofi has decided to temporarily suspend the supply and sale of influenza vaccines in China. Sanofi China stated that all circulating and used vaccines meet the necessary quality standards for release, and no signs or evidence of product safety and efficacy being affected have been found. The decision to temporarily suspend the supply and sale of these vaccines in China is only a preventive measure. The company further stated that it has suspended the influenza vaccine for the 2024-2025 flu season nationwide and has initiated the return process proactively.
In early trading today, domestic influenza vaccine stocks opened higher one after another, with Hualan Vaccine and Jindike rising sharply by "20cm" to the daily limit up. Vaccine companies such as Baike Biotechnology, Hualan Biotechnology, and Zhifei Biotechnology also collectively rose red.
It is understood that currently, the main suppliers of influenza vaccines in China include Hualan Biotechnology, Jindike, Sinovac Biotech, as well as Changchun Institute, Wuhan Institute, and Shanghai Institute under Sinopharm Group.
Sanofi responds: supply suspended due to decreased potency
Late in the night of August 26, many WeChat groups and childcare official account in Shanghai reported that Jiahui Medical had suspended the vaccination of Sanofi's Pasteur influenza vaccine. The vaccines involved were trivalent influenza virus split vaccine (trade name: Valin) and tetravalent influenza virus split vaccine (trade name: Valga).
It is reported that a large proportion of the population receiving the two suspended flu vaccines are children. Valin is suitable for adults and children over 36 months old, while Valjia is suitable for people aged 6 months and above.
On the afternoon of the 27th, a reporter from Shanghai Securities News consulted Sanofi China as a consumer. The company stated that during the ongoing stability testing process, Sanofi observed a decreasing trend in the potency of the influenza vaccines Valin and Valga during the 2024-2025 influenza season (relevant reference data for the expected biological effects of the vaccines).
According to the official website of Sanofi, the company currently has two flu vaccines on the market in China. On February 21, 2023, the Sanofi quadrivalent influenza virus split vaccine, Vernier, was approved by the National Medical Products Administration for influenza prevention in infants and young children aged 6-35 months; In May of the same year, the vaccine was expanded to cover the entire population (aged 6 months and above). In July 2023, Sanofi quadrivalent influenza vaccine will be officially supplied to the Chinese market.
Sanofi is currently one of the world's largest suppliers of influenza vaccines, with global sales of 2.977 billion euros and 2.669 billion euros in 2022 and 2023, respectively.
It is worth noting that the manufacturer of Sanofi influenza vaccine is Shenzhen Sanofi Pasteur Biological Products Co., Ltd. (referred to as "Sanofi Pasteur"), and there has been a recall precedent before. In April 2018, Sanofi Pasteur reported that the company had found a decreasing trend in the efficacy of some batches of influenza virus split vaccines during routine monitoring, and actively recalled the relevant batches of influenza virus split vaccines, with a recall level of three.
Domestic influenza vaccine is popular
In response to the discontinuation of Sanofi's influenza vaccine supply, the market generally expects domestic influenza vaccine companies to gain more market share and attention.
After the opening of the market this morning, Hualan Vaccine and Jindike hit the daily limit up, while other listed companies involved in influenza vaccines, including Hualan Biotechnology, Baike Biotechnology, Zhifei Biotechnology, etc., also saw impressive gains.
At present, domestic companies are relatively mature in the research and reserve of influenza vaccines.
According to the 2023 annual report of Hualan Vaccine, the company has obtained the "Drug Registration Certificate" for influenza vaccines including quadrivalent influenza virus split vaccine, quadrivalent influenza virus split vaccine (children's dosage form), and H1N1 influenza virus split vaccine. From 2021 to 2023, the company received 100 batches, 103 batches, and 94 batches of influenza vaccines respectively, and the number of influenza vaccine batches issued continues to remain the highest in China.
Jindike is the second domestic enterprise to obtain approval for the issuance and sale of quadrivalent influenza vaccines. The company stated in its 2023 annual report that its quadrivalent influenza vaccine related indicators are superior to the standards of the Chinese Pharmacopoeia and the European Pharmacopoeia. The company is deeply developing a series of quadrivalent influenza vaccine products, including a pediatric quadrivalent influenza vaccine focused on infants and young children aged 6 to 3 years old, and a high-dose quadrivalent influenza vaccine focused on elderly people aged 65 and above.
The Shanghai Stock Exchange reporter called the Secretary General's Office of Hualan Vaccine as an investor. Regarding whether the production capacity and batch issuance of Sanofi's influenza vaccine will accelerate after the suspension of vaccination, the staff stated that these are all preliminary tasks. Currently, the company has already issued many batches of influenza vaccines and has begun to supply the market. Some markets can now be vaccinated, and the company's production volume can meet market demand.
Industry insiders have pointed out that due to the production cycle of vaccines, including batch issuance, which takes a long time, the production plan of vaccine manufacturers is usually set at the beginning of the year. The duration and continued impact of Sanofi's suspension of influenza vaccine supply cannot be determined at this time, and further response from the company is needed.
Previously, the domestic market for quadrivalent influenza vaccines had already shown some signs of chill. In the first half of this year, the quadrivalent influenza vaccine experienced a wave of collective price reductions. In May of this year, China National Pharmaceutical Group was the first to lower the price of quadrivalent influenza vaccines to below 100 yuan, and then companies such as Hualan Vaccine, Sinovac Biotech, and Jindike also lowered their prices. Nowadays, the profits of quadrivalent influenza vaccines have declined significantly compared to before.
And whether Sanofi's temporary suspension of influenza vaccine supply can open up greater market space for domestic influenza vaccine companies needs to be continuously monitored.
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