Humedix, a subsidiary of Huons, said Wednesday that it has completed phase 3 clinical trials for Humia, the company’s hyaluronic acid treatment for osteoarthritis.
The treatment combines the company’s high-purity hyaluronic acid production technology with the proprietary biological polymer biotechnology.
The company conducted the phase 3 clinical trials to confirm the efficacy and safety of the drug on osteoarthritis patients at 13 hospitals, including Seoul National University Hospital. They had initially received clinical test approval from the Ministry of Food and Drug Safety in 2016.
The results of the trial demonstrated that a single dose of the drug lasted up to six months, confirming the equivalent duration of the drug with fewer doses when compared to other conventional hyaluronic acid osteoarthritis medications.
Patients had felt inconvenient as they needed to administer hyaluronic acid osteoarthritis medications up to five times a week at the most.
The company expects that the new drug, if approved, will significantly increase the convenience of patients as it will eliminate the inconvenience of having to go to the hospital regularly several times a week.
Humedix will obtain sales approval for Humia based on the results of phase 3 clinical trials and expect to release the product in the second half of this year. The company also plans to expand its osteoarthritis market share along with its already released Highhyal Plus Inj. and Airon Inj.
“Through the phase 3 clinical trials, we have confirmed the convenience and efficacy of Humia,” Humedix CEO Jeong Gu-wan said. “The company plans to expand its overseas markets by emphasizing the increased convenience of the drug, starting with countries in Southeast Asia, such as Vietnam where we are exporting Highhyal Plus Inj. and Airon Inj.”
Humedix will manufacture its new medication at its newly constructed cGMP-level factory.
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