Japan

Shionogi to apply for approval of first Japan-made oral COVID drug

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Japanese pharmaceutical company Shionogi & Co. plans to apply for government approval to sell its oral COVID-19 drug as early as next week, the company announced Monday.

If approved, it will be the first oral drug developed by a domestic company to treat COVID-19 patients.

The company, which has already started producing the drug, plans to manufacture enough doses for one million patients by March.

The company aims for annual production capacity of the drug for more than 10 million patients from April.

This drug is expected to be a key weapon in the pandemic fight. Once the application is submitted, the Health, Labor and Welfare Ministry will aim to conduct relevant procedures swiftly, while carefully examining the drug’s safety and efficacy.

“We will file an application next week or the week after, and we are discussing [with the health ministry and others] whether we could start supplying [the drug] by the end of February or early March,” Shionogi President Isao Teshirogi said at a press conference in Tokyo on Monday.

Shionogi started manufacturing the drug before filing the application so that it would be able to supply the drug immediately after obtaining approval.

“We have built up production to the point where we can provide 400,000 to 500,000 people with the drug by the end of February,” Teshirogi said.

In a clinical trial, 69 COVID-19 patients were given either the Shionogi drug or a placebo orally once a day for five days.

The ratio of the participants who had infectious virus after taking three doses decreased by 80% for those who received a high dose of the medication, and fell by 63% for those with a low medication dose.

The group that took the drug produced negative test results two days before patients who took the placebo.

While two of the 14 patients in the placebo-controlled group became seriously ill, none of the patients who took the drug developed serious symptoms that required hospitalization.

Shionogi is also analyzing data from an ongoing trial with about 400 patients. Depending on the data, the company intends to apply for approval without waiting for the results from the final stage of the trial.

Only two oral COVID-19 drugs are currently in practical use, produced by the U.S. pharmaceutical firms Merck & Co. and Pfizer Inc.

The Merck drug is prohibited for pregnant women, while Pfizer’s medication, which is believed to have high efficacy, is in high demand worldwide, raising the risk that doses will be difficult to secure.

Given the situation, expectations are high for domestically produced oral drugs.

Shionogi is competitive in the development of antiviral drugs, and succeeded in creating a compound for an oral drug in just nine months. It is said that the process usually takes at least five years.

According to a senior Shionogi official, the company was able to rapidly develop the drug because it “concentrated 70% to 80% of its resources,” on the project.

The government has also been supportive, providing financial support to the company, including/in the form of a subsidy worth ¥2 billion in October.

The government also established a system enabling clinical trials to be conducted on COVID-19 patients recuperating at hotels.

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