Daewoong Pharmaceuticals' Head of New Drug Development, Joon-Seok Park, unveiled the company's forward-thinking approach to drug development during the '2023 Open Innovation Plaza' held by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on November 14th. He detailed the growth trajectory for 'Envlo,' the groundbreaking SGLT-2 inhibitor series drug designed for diabetes treatment.

Envlo, the 36th new drug developed in South Korea, made its official debut in May. This SGLT-2 inhibitor, with its minute 0.3mg dosage, a mere 1/30th of comparable drugs, has showcased remarkable efficacy in reducing blood sugar levels while ensuring safety. Its approved uses encompass monotherapy, combination therapy with Metformin, and triple therapy with Metformin and Gemigliptin.

Park outlined the genesis of Envlo, emphasizing its roots in open innovation. He spotlighted the acquisition of the candidate substance Ipragliflozin from GC Biopharma, marking a pivotal moment in Daewoong Pharmaceuticals' journey. This strategic move, initiated in June 2014 and finalized in May 2016, exemplifies the company's commitment to forging successful collaborations.

Furthermore, Daewoong Pharmaceuticals' focus on advancing its proprietary new drugs gained traction after regaining domestic rights for the diabetes treatment 'Januvia' from MSD (Merck) in 2016. Park underscored the unique mechanism of action of SGLT-2 inhibitors, not just limited to diabetes management but potentially extending to cardiovascular diseases and hypertension, broadening their therapeutic scope.

Envlo stands as the fifth SGLT-2 inhibitor in South Korea and the eighth globally. Park highlighted its exceptional potency in inhibiting the SGLT-2 target protein, particularly its high distribution within the kidneys, resulting in heightened effectiveness compared to existing counterparts.

The extensive success of Envlo in clinical trials, even at low doses, has been a pivotal milestone. Phase 3 trials, conducted based on regulatory advice utilizing a 0.3mg dosage, confirmed its exceptional efficacy, underscoring the collaborative efforts with GC Biopharma.

Daewoong Pharmaceuticals has already commenced Envlo's distribution in Central and South American regions, with plans for broader global expansion. Additionally, the drug's indications are expanding, with Phase 2 clinical trials underway for obesity and Phase 1 trials approved for macular degeneration—an exciting step towards diversifying its applications.

Park concluded by affirming Daewoong Pharmaceuticals' commitment to innovative drug development, propelled by strategic partnerships and an unwavering dedication to expanding Envlo's therapeutic horizons.