Daewoong Receives China Phase 3 Approval for Diabetes Treatment 'Inavogliflozin'
[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical has strengthened its export portfolio to China by obtaining approval for the Phase 3 clinical trial of its new diabetes treatment drug, Inavogliflozin, in China.
On the 22nd, Daewoong Pharmaceutical announced that it received approval from the National Medical Products Administration (NMPA) of China for the Phase 3 clinical trial of Inavogliflozin, a new SGLT-2 inhibitor diabetes drug, in combination with metformin. This came just three months after submitting the Clinical Trial Application (CTA) in November last year.
Daewoong Pharmaceutical plans to immediately proceed with the Phase 3 clinical trial targeting patients with type 2 diabetes in China. According to the topline results of a similar Phase 3 clinical trial conducted domestically in January, the combination therapy of Inavogliflozin and metformin demonstrated non-inferiority compared to the combination therapy of dapagliflozin and metformin. Daewoong Pharmaceutical aims to obtain approval for Inavogliflozin in China by 2025.
Inavogliflozin is the first SGLT-2 inhibitor diabetes treatment drug developed by a domestic pharmaceutical company in Korea. In Phase 3 trials conducted domestically?including monotherapy, dual therapy with metformin, and triple therapy with metformin and DPP4 inhibitors?Inavogliflozin demonstrated excellent efficacy and safety in a total of 630 patients with type 2 diabetes whose blood sugar was inadequately controlled. The domestic launch is targeted for next year.
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Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, “Receiving approval or clinical trial plans for Nabota, Pexuprazan, and now Inavogliflozin in China is proof of Daewoong Pharmaceutical’s outstanding technological capabilities. By rapidly realizing Daewoong Pharmaceutical’s global new drug portfolio, we will further ignite the company’s growth engine and alleviate the discomfort of diabetes patients worldwide.”
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