Regarding The Oral Medicine For Covid-19, Shionoyi's Latest Response

Osaka, Japan, April 13, 2022 – Tesirogi Isao, President and CEO of Shionogi Co., Ltd., announced that Shionogi summarized his views on recent media reports on the oral antiviral drug S-217622 for COVID-19.

On April 4, 2022, Shionogi received a request from a Japanese news agency to confirm information they had obtained from their own interviews regarding certain non-clinical data on S-217622 and to provide our own opinion. The information is that abnormal fetal skeletal morphology was observed in a nonclinical safety study of S-217622.

On April 6, Shionogi responded that such an observation had arisen and shared the company's assessment of the significance of these nonclinical results from a clinical perspective. The non-clinical study results were reported to the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in December 2021 and included in the NDA filing on February 25, 2022.

(1) This nonclinical study was conducted as one of the regulatory safety studies required for drug development. These observations were made at doses higher than clinical doses, exceeding expected human blood concentrations and dosing periods.

(2) Pregnant, lactating and potentially pregnant women are generally excluded from clinical trials, as was the case with S-217622.

(3) Report the results of this non-clinical study to the medical institution conducting the clinical trial in a timely manner, and inform the clinical subjects of risk-related information including the results, and participate in the clinical trial after informed consent.

(4) The clinical significance of the non-clinical findings will be comprehensively judged in PMDA's ongoing approval review, and the content of the package insert will be determined through this process.

In conclusion, Shionoyoshi believes that this matter will not affect the approval decision of S-217622. The company will continue to work with PMDA while advancing ongoing clinical trials to gather additional information on safety and efficacy.

Shionoyi’s shares closed down 8% today, with a current market value of around $17.9 billion.