Shots:

• The approval follows PR designation and is based on P-III KRONOS study assessing budesonide/glycopyrronium/formoterol fumarate vs Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate- demonstrated significant improvement in FEV1
• The approval marks the first NMPA approval for a fixed-dose triple-combination regimen in a pressurized metered-dose inhaler device which utilizes Aerosphere delivery technology
• Breztri Aerosphere is an approved triple combination therapy in Japan and is under regulatory review in the US & EU. The triple combination regimen is k/a PT010 outside of China

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