A wide range of news on Hana Pharm
- Leveraging Hana Pharm's new GMP facility with publicly confirmed financial investment upto $ 55 M. for a possible remimazolam supply to the global market by securing Southeastern Asian commercialization rights
- NDA filed with MFDS, S. Korea in December 2019, lastly
Seoul,S. Korea, Jan 9, 2020
Hana Pharm Co., Ltd., S. Korea ( 293480, Younha Lee, Ph.D., CEO) announces today that it has extended the license agreement for remimazolam with PAION AG, Germany which grants Hana Pharm an exclusive license for the major 6 Southeastern Asian countries.
Hana Pharm entered into an exclusive remimazolam license agreement for South Korea in 2013 and expands the exclusive license to the Southeastern Asian countries including Vietnam, Indonesia, Thailand, Philippines, Singapore and Malaysia.
Paion will receive an upfront payment in the amount of EUR 1.5 million and also, milestone payments related to the product approval and launch in the extended territories.
Dr. Younha Lee, CEO of Hana Pharm stated:
" With this expanded agreement in place, we are pleased and anticipate synergistic effect of the established partnership between Paion AG and Hana Pharm providing a framework for us to possibly supply remimazolam not only to S. Korea but also to Southeastern Asian countries.
Hana Pharm is committed to supply global market with injectables which are conform with regulations in the US, EU and Japan from its new GMP facility in the near future."
Hana Pharm announced a strategic corporate decision about the financial investment upto $50 M. into a new injections manufacturing facility in Novemver 2019, lastly.
Currently, it is being designed and about to break ground sometime in the next couple of months.
Upon completion of the facility, export business of remimazolam will be full-fledged.
Remimazolam which is indicated for general anesthesia, procedural sedation and ICU sedation is a new anesthetic drug candidate, being either clinically developed or NDA filed in the US, EU and Japan with the favorable safety profile having its own reversal agent.
Hana Pharm had successfully completed P3 study of remimazolam in general anesthesia in the major local hospitals in February 2019 and filed NDA with MFDS on December 30, 2019, lastly.