NewGLabPharma Subsidiary Receives Approval for Phase 1 Application of Diabetes Combination Drug

[Asia Economy Reporter Hyungsoo Park] NewG Lab Pharma announced on the 15th that its drug development subsidiary, NewG Lab Therapeutics, has received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial of the diabetes combination therapy drug ‘NGL-101’.

NGL-101 is a combination drug that merges two leading diabetes treatment components into a single pill. It is expected not only to improve dosing convenience but also to deliver superior therapeutic effects.

The main ingredients of NGL-101, dapagliflozin and sitagliptin, have clinical evidence supporting their use, allowing market approval with just a Phase 1 clinical trial. This is expected to enable rapid market entry. Dapagliflozin is the same ingredient as AstraZeneca’s FORXIGA, the market leader in SGLT-2 inhibitors, and sitagliptin is the same ingredient as MSD’s JANUVIA, the top performer in the DPP-4 inhibitor market.

The domestic diabetes treatment market is dominated by FORXIGA and JANUVIA, with most patients receiving combination prescriptions. According to industry sources, in 2020, the domestic off-prescription sales of FORXIGA amounted to 64.8 billion KRW, and JANUVIA’s off-prescription sales reached 176.2 billion KRW.

Once NGL-101 receives market approval, the product will be manufactured by the subsidiary Arije Pharm, which has KGMP-certified facilities, and distributed by the parent company NewG Lab Pharma. This is expected to maximize synergy between affiliated companies. NewG Lab Pharma has obtained pharmaceutical wholesale and retail licenses for drug distribution.

A representative from NewG Lab Therapeutics stated, "We plan to launch NGL-101 in September next year, coinciding with the expiration of JANUVIA’s patent," adding, "We intend to release two to three or more new products annually."

He further added, "In addition to the diabetes combination therapy, we are preparing to launch multiple new products, including a bioequivalence study for a generic drug with improved dosing convenience for urological diseases and a new formulation of over-the-counter drugs for pain and rhinitis treatment."

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