Hana Pharm said Thursday that it is conducting phase 3 trials for a new sedative anesthetic agent called remimazolam (HNP-2001).
The ultrashort-acting anesthetic has proved to have all the advantages of existing anesthetics such as propofol and midazolam while having an excellent sedative effect, rapid recovery, and low respiratory suppression side effects. It is also hydrolyzed rapidly in the body while remains stable, given it carries less hepatoxicity risk in the metabolic process.
Hana Pharm signed a partnership agreement with German pharmaceutical firm Paion in 2013 to gain the raw material, finished product manufacturing, and formulation technology of remimazolam.
Paion had selected Hana Pharm as an exclusive partner in Korea, proving the latter’s excellent R&D and sales capabilities in the anesthesia sphere.
Hana Pharma expects to strengthen its position in the anesthetic market by securing domestic rights. After obtaining approval for the third phase of clinical trials in October last year, the firm launched P3 clinical trials in March. The company aims to launch the anesthetic in 2021.
According to Hana, global trials for remimazolam are underway with various local partners. More than 1,700 participants have signed up for the phase 3 tests, making it only a matter of time until verifying safety and efficacy of the drug, the firm said.
Hana would use a portion of its public offering funds acquired through the KOSPI listing for the launch of remimazolam and its production lines. The company plans to build a new EU-GMP-scale plant specialized in producing injectable products and build a mass production system by constructing a freeze-drying line dedicated to remimazolam.
“We have secured domestic rights to remimazolam, an innovative drug for anesthetic agents, and have been proceeding with the third phase of clinical trials in Korea since March this year,” a Hana Pharm official said. “We will secure a new growth engine for Hana Pharm as we continue to expand research personnel and invest in clinical trials and production facilities,”
Hana Pharm is also researching MRI contrast agents, with plans for P1 trials, as well as therapies for diabetic retinopathy and nonalcoholic steatohepatitis.