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W ith the next marketing approval the year 2021 gets off to a promising start for PAION, and we congratulate Hana Pharm on this achievement, said Dr. Jim Phillips, CEO of PAION AG. With the recently started construction of their own production plant for BYFAVO TM, our partner continues to invest in the success of BYFAVO TM and we are looking forward to the upcoming market launch. Dr. Younha Lee, CEO of Hana Pharm, announced: We are thrilled to announce BYFAVO TM approval in South Korea and sincerely thankful for the rewarding partnership with PAION since 2013. Today s approval allows us to leverage Hana Pharm s significant development and commercialization expertise in anesthesiology in South Korea. We will be accelerating the remaining process towards product launch in South Korea and also the regulatory and commercial partnering progress in Singapore, Thailand, Vietnam, Indonesia, the Philippines and Malaysia this year. ....
DGAP-Ad-hoc: PAION AG / Key word(s): Regulatory Approval PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO) IN GENERAL ANESTHESIA IN SOUTH KOREA 07-Jan-2021 / 11:14 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO TM) IN GENERAL ANESTHESIA IN SOUTH KOREA Aachen (Germany), 07 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces that Hana Pharm, remimazolam licensee for South Korea, today informed PAION that South Korea s Ministry of Food and Drug Safety (MFDS) has approved the New Drug Application (NDA) for BYFAVO ....