Bioson Pharmaceutical Obtains MFDS Approval for Onaprazju... "Birth of Non-Opioid Analgesic Innovative Drug"

Vivozon Pharmaceutical announced on the 13th that its non-narcotic analgesic Anapraju (generic name Opiranjelin) has received marketing authorization from the Ministry of Food and Drug Safety. With this, Anapraju became the 38th domestically developed new drug in Korea.

Discovered through multi-target new drug development platform technology, Anapraju is the world's first non-narcotic, non-anti-inflammatory analgesic. It works by simultaneously inhibiting Glycine Transporter 2 (GlyT2) and Serotonin Receptor 2a (5HT2a), blocking pain signals and transmission occurring at multiple sites in both the central and peripheral nervous systems.

Previously, Vivozon Pharmaceutical secured statistical significance for efficacy in domestic Phase 3 clinical trials and applied for marketing authorization from the Ministry of Food and Drug Safety in November last year. Efficacy was confirmed through the primary endpoint 'Sum of Pain Intensity Difference over 12 hours (SPID 12)' and secondary endpoints 'Number of patient-controlled analgesia (PCA) requests over 12 hours' and 'Consumption of PCA and rescue medication over 12 hours.'

This approval is expected to bring a revolutionary change to the moderate or higher pain treatment market, where there are no alternatives other than narcotic analgesics and unmet medical needs are high. From the clinical stage, Anapraju has been evaluated as a 'game changer' in the medical community due to its lower side effects and no addiction risk compared to narcotic analgesics, while demonstrating rapid analgesic effects.

The company stated that although Anapraju holds the title of a domestically developed new drug, it differs significantly from previous domestic new drugs. While previous domestic new drugs were imitation drugs such as Best In Class or Me Too drugs within their class, Anapraju is meaningful as the first innovative new drug (First In Class) with a very high development difficulty.

A Vivozon Pharmaceutical representative said, "We are pleased to share the news of new drug approval with shareholders and investors who have trusted and waited for the company for a long time," adding, "This approval will accelerate the product launch and marketing activities we have been preparing for."