Shionogi Seeks Japan Approval for COVID-19 Vaccine
TOKYO (Reuters) – Shionogi & Co Ltd said on Thursday it had filed for approval in Japan of its experimental COVID-19 vaccine.
The move comes two days after Japanese regulators granted emergency approval for Shionogi’s oral treatment for COVID, the first for a domestic drugmaker.
The filing for the recombinant protein-based vaccine, known as S-268019, was based on results from five clinical trials in Japan, Shionogi said in a statement.
The company seeks to market the shot as a primary vaccine and booster against the coronavirus.
The drugmaker’s stock surged in early trade before paring gains on the first trading day since the approval of its COVID pill.
Regulators in Japan had previously denied emergency approval for the drug, a protease inhibitor known as ensitrelvir, saying they wanted to see more data on its effectiveness. There were also concerns that the drug could pose a risk to pregnancies, based on results from animal studies.
Shionogi last month raised its full-year sales forecast on expectations that it would win regulatory approval. The company has signed an agreement to sell about a million doses to the Japanese government, pending approval, and has received U.S. government funding for a global trial.
The pill would compete with oral COVID-19 treatments developed by Pfizer Inc and Merck & Co which have already been approved in Japan.
Shionogi shares were up 0.6% in Tokyo, compared to a 1.1% advance in the benchmark Nikkei gauge. The stock earlier surged as much as 5.9%.
(Reporting by Rocky Swift; Editing by Rashmi Aich)
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