LG Chem Submits Marketing Authorization Application for Zemidafam ER Tablet 50/10/1000 mg in South Korea, Clinical Data Show Efficacy and Safety
LG Chem has submitted a marketing authorization application to the Ministry of Food and Drug Safety MFDS for Zemidafam ER Tablet 50/10/1000 mg, a triple combination therapy for type 2 diabetes. This product aims to improve treatment convenience for patients inadequately controlled on dual therapy.
Clinical trials demonstrated that the triple combination of gemigliptin, dapagliflozin, and metformin was superior to mono or dual therapies in reducing HbA1c, with a favorable safety profile. Key studies showed significant HbA1c reductions versus placebo.
The company plans to launch the product in 2027. This application is a key milestone for strengthening its diabetes treatment portfolio. However, final approval is subject to regulatory review and uncertainty remains.
[AI Summary]LG Chem's domestic filing for Zemidafam ER Tablet is an R&D milestone with no capital dilution or share issuance. Positive clinical data support potential if approved, but approval risk persists. No changes to the company's financial health or credit profile.
KOSPI Filing Information
Major Management Matters Related to Investment Judgment (Application for Domestic Product Approval of Gemidapaem Seobangjeong)