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Shionogi starts document submission for S-217622 to treat COVID 19 in China.
Shionogi has commenced the submission of preparatory documents for a new drug application of its COVID-19 drug S-217622 in China through a joint venture with a local company.
The joint firm with Ping An Life Insurance, called Ping An-Shionogi, submitted the documents to the Center for Drug Evaluation of the China National Medical Products Administration (NMPA). The submission of preparatory documents will facilitate the NDA process. For the Chinese submission, Shionogi plans to use the same clinical and preclinical study data as those that have been filed in Japan. The company places its top priority on work related to obtaining emergency approval in Japan and has also expressed its plans to expand the drug into global markets.
Condition: Coronavirus/COVID-19 Infection
Type: drug