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DGAP-News: PAION AG
/ Key word(s): Regulatory Admission
09.07.2021 / 11:30
The issuer is solely responsible for the content of this announcement.
PAION ANNOUNCES THAT NMPA ACCEPTS SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BESYLATE IN GENERAL ANESTHESIA BY CHINESE LICENSEE YICHANG HUMANWELL
Aachen (Germany), 09 July 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that its Chinese remimazolam licensee Yichang Humanwell informed PAION that the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.
Yichang Humanwell recently successfully completed the clinical development for remimazolam besylate in general anesthesia.
Dr. Jim Phillips, CEO of PAION AG, commented: "Yichang Humanwell has already made great progress in the China market with Ruima(R) (remimazolam besylate) in procedural sedation, exceeding our initial expectations. We are therefore very pleased that the second indication for use in general anesthesia has been submitted under an NDA, and look forward to the outcome of the NMPA review, and possibly further market expansion for use."
Remimazolam besylate (brand name Ruima(R)) was approved in China for procedural sedation during colonoscopy in July 2020.
Byfavo(R) (remimazolam besylate)
Byfavo is an ultra-short-acting intravenous benzodiazepine sedative. In the human body, Byfavo is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Byfavo can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. Data demonstrate that Byfavo has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
About PAION
PAION AG is a publicly listed specialty pharmaceutical with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. PAION's lead compound is Byfavo (remimazolam besylate), an intravenous, ultra-short-acting benzodiazepine sedative, approved in Europe for procedural sedation. Remimazolam besylate is partnered in multiple territories and different indications outside of Europe. It is marketed in the U.S. as BYFAVO(TM) by Acacia Pharma, in Japan as Anerem(R) by Mundipharma, in China as Ruima(R) by Yichang Humanwell and in South Korea as Byfavo(TM) by Hana Pharm.
In addition to Byfavo(R), PAION is preparing to launch the two products GIAPREZA(R) (angiotensin II) and XERAVA(R) (eravacycline) in Europe. Giapreza is a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. Xerava is a novel fluorocycline type of antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany).
Contact
Ralf Penner
Vice President Investor Relations/Public Relations
PAION AG
Heussstrasse 25
52078 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG' management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update such forward-looking statements to reflect future events or developments.
09.07.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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