Shinpoong Pharmaceutical said Tuesday that the Ministry of Food and Drug Safety has selected SP-8203, its acute ischemic stroke treatment, as part of its “Pharm Navi” program.
SP-8203 is a drug that significantly reduces stroke-related mortality and prognosis, along with reduced adverse effects of rtPA, the current standard therapy for stroke. The company has proven its safety and efficacy through phase 1 and 2a clinical trials.
The Pharm Navi program is the ministry’s new drug development project similar to the U.S. Food and Drug Administration’s Fast Track program. If selected, the company can receive support for product development and global advancement as well as active support on R&D at a government level.
“SP-8203 has been selected as a Pharm Navi-designated item as it is an innovate stroke treatment that has a high unmet medical need,” a company official. “We will receive institutional and technical support from the food and drug safety ministry concerning the real-time permit and review process so that the results of our R&D can be quickly linked to the commercialization.”
The company has been conducting phase 2b clinical trials in 14 clinical sites with the support from the Ministry of Health and Welfare since last year.
“With the selection of Pharm Navi program, we will be able to accelerate clinical trials both in Korea and abroad,” the official added.
<© Korea Biomedical Review, All rights reserved.>