[Asia Economy Reporter Chunhee Lee] Medytox Korea's next-generation botulinum toxin formulation ‘MBA-P01’ has completed its Phase 3 clinical trial. The goal is to obtain approval within this year.
Medytox's affiliate Medytox Korea announced on the 5th that the domestic Phase 3 clinical trial for MBA-P01 was completed as the final visit of the clinical trial subjects ended on the 30th of last month.
To launch ‘MBA-P01’ domestically, Medytox Korea received approval for the Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety in June last year and conducted comparative studies on efficacy and safety with 318 adults requiring improvement of moderate to severe glabellar lines. After data compilation and report preparation, they plan to apply for product approval from the Ministry of Food and Drug Safety as early as next month.
MBA-P01 is a toxin formulation that applies a new manufacturing process for the raw material and uses the latest production technology to improve production yield and quality compared to existing products. Like Medytox’s existing formulations ‘Innotox’ and ‘Coretox,’ only non-animal-based media were used during the strain cultivation process.
A Medytox Korea official stated, "With the Phase 3 clinical trial of MBA-P01 completing faster than planned, we have taken a step closer to obtaining marketing approval this year," adding, "We will also make every effort to establish marketing strategies for the rapid market entry and market share increase of MBA-P01."
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