Shionogi seeks Japan’s approval for COVID-19 vaccine

TOKYO, November 24 (Reuters)Shionogi & Co Ltd 4507.T said on Thursday that it had sought Japan’s approval 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 of the recombinant protein vaccine, known as S-268019, was based on the results of five clinical trials in Japan, Shionogi said in a statement.

The company is looking to market the vaccine as a primary and booster vaccine against the coronavirus.

Shares of the drugmaker jumped in early trading before paring gains on the first trading day since its COVID pill was approved.

Regulators in Japan had previously emergency approval denied 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 posed a risk to pregnancies, based on the results of animal studies.

Shionogi last month raises its revenue forecast for the full year on expectations that it would obtain regulatory approval. The company has signed an agreement to sell approximately one million doses to the Japanese government, pending approval, and has received US government funding for a global trial.

The pill would compete with oral COVID-19 treatments developed by Pfizer Inc. PFE.N and Merck & Co. MRK.N which have already been approved in Japan.

Shares of Shionogi rose 0.6% in Tokyo, against a 1.1% advance for the benchmark Nikkei .N225 gauge. The stock jumped up to 5.9%.

(Reporting by Rocky Swift; Editing by Rashmi Aich)

((rocky.swift@thomsonreuters.com;))

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