Major South Korean pharmaceutical companies are waiting for the U.S. Food and Drug Administration’s (FDA) approval for their novel drugs, raising expectations for the possible release of the first FDA-approved Korean blockbuster drug.

Hanmi Pharmaceutical and Yuhan Corp. have filed for FDA approval for their non-small cell lung cancer (NSCLC) treatments. Because none of NSCLC treatment has received FDA approval yet, one of their drugs could be Korea’s first FDA-approve blockbuster drug if granted.

Hanmi Pharmaceutical licensed out its NSCLC treatment, Poziotinib, to U.S.-based Spectrum Pharmaceuticals in February 2015. Hanmi Pharm submitted a New Drug Application (NDA) for poziotinib to the FDA on Jan. 7.

Yuhan’s NSCLC treatment, lazertinib, was originally developed by Oscotec Inc. and was licensed out to Yuhan Corp. in 2015 and then sublicensed globally to Janssen in 2018 for 1.4 trillion won ($1.1 billion). If lazertinib receives FDA approval, Yuhan will receive a milestone payment of 200 billion won from Janssen.

Janssen is currently conducting Phase 3 clinical trials for lazertinib and amivantamab combination therapy. If it is granted a fast-track designation, it may receive FDA approval within this year.

GC Pharma’s plasma-derived immunodeficiency drug, IVIG-SN, is also garnering attention. The FDA previously rejected the license application for IVIG-SN, asking the company to provide supplementary information on the drug’s manufacturing procedures. IVIG-SN currently accounts for 36 percent of GC Pharma’s total sales.

IVIG-SN is an immunoglobulin formulation made by separating and purifying certain proteins from plasma, the fluid part of blood, and is used to treat primary immunodeficiency diseases (PIDDs) such as congenital immunodeficiency and immunodeficiency. In February last year, GC Pharma filed for FDA-approved indication for IVIg-SN 10% use in primary immunodeficiency. The FDA approval decision will be announced late next month, and if granted FDA approval, IVIG-SN will lead the American immunoglobulin drug market which is worth 10 trillion won.

Another Korean pharmaceutical company Mezzion Pharma may release the world’s first Fonton treatment. Mezzion Pharma submitted an NDA application to the FDA for Udenafil, a treatment for patients 12 years of age and older who have undergone the Fontan operation for single ventricle heart disease (SVHD). Udenafil has been granted a priority review which will shorten the FDA`s review of the application to six months.

By Kim Si-gyun and Susan Lee

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