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Japan’s Shionogi Says COVID Drug Reaches Phase III Milestone According to Reuters



© Reuters. FILE PHOTO: Isao Teshirogi, President and CEO at Shionogi & Co Ltd, speaks during an interview with Reuters in Tokyo, Japan June 11, 2019. REUTERS/Issei Kato

TOKYO (Reuters) – Japan’s Shionogi & Co Ltd on Wednesday said its oral treatment for COVID-19 demonstrated a significant reduction in symptoms compared with a placebo in a phase III trial. in Asia.

The company said the drug, a protease inhibitor called ensitrelvir, met its primary criteria in a trial conducted on primarily vaccinated patients with COVID-19 cases from mild to moderate, the company said in a statement.

Shionogi shares jumped after the announcement, rising 2.5% in afternoon trading in Tokyo compared with a 2.1% drop in the benchmark gauge.

Regulators in Japan had previously denied emergency approval for the pill’s use, saying they wanted to see more data on its effectiveness. There are also concerns that the drug may pose a risk to pregnancy, based on results from animal studies.

Shionogi said it shared leading data from the Phase III study with Japanese regulators as part of the drug approval review process.

Shionogi has global aspirations for a drug, also known as S-217622 and brand name Xocova, that will compete with its COVID-19 drug. Pfizer Inc (NYSE:) and Merck & Co Inc. have been approved in Japan and elsewhere.

The company has signed an agreement to sell about one million doses of the drug to the government, pending approval of the drug.

CEO Isao Teshirogi said annual drug production could reach 10 million doses. The company has received US government support for the global phase III test.



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