CrystalGenomics Completes NDA Submission for 'Aselex' New Drug Approval in Russia

[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 4th that it has completed the New Drug Application (NDA) for the sale of the osteoarthritis pain and anti-inflammatory drug 'Aselex (active ingredient Formacoxib)' to the Ministry of Health (MOH) of the Russian Federation.

Previously, CrystalGenomics conducted a Phase 3 clinical trial in Russia involving 250 knee joint patients, dividing them into two groups: one receiving Aselex 2mg once daily and the other receiving Pfizer's Celebrex 200mg. The study was designed as a non-inferiority test (to confirm equal or superior efficacy) to evaluate treatment effectiveness and safety.

According to the topline data results, the company explained that non-inferiority treatment effects were successfully demonstrated across all measures, including the WOMAC OA Index (assessment scale for joint pain, function, and stiffness), VAS (Visual Analog Scale for pain), 15-meter walking time, OMERACT-OARSI (symptom improvement evaluation), and Lequesne index (comprehensive scale for pain, function, and disability). No serious or unexpected adverse effects were observed.

In 2018, CrystalGenomics signed an export contract worth approximately $121.5 million (about 195 billion KRW) with the Russian pharmaceutical company 'Pharmatis International' for Aselex 2mg capsules.

A CrystalGenomics representative stated, "The COX-2 inhibitor market, to which Aselex belongs, is showing the highest annual growth rate exceeding 30% in Russia, and it is expected to play a key cash cow role."

This content was produced with the assistance of AI translation services.