CTC Bio said it has obtained marketing authorization for two oral dissolving film (ODF)-type erectile dysfunction treatments in three countries -- Thailand, Mexico, and Chile.
The products approved for sale are reformulated versions of sildenafil (original: Viagra) and tadalafil (original: Cialis).
"We have obtained marketing authorization for sildenafil in Thailand and tadalafil in Mexico and Chile," the company said. "Considering that the market size of erectile dysfunction drugs in Thailand, Mexico, and Chile is approximately 180 billion won ($135.9 million), 300 billion won, and 40 billion won, we expect rapid sales growth in the future."
The approval in the three countries follows CTC Bio's recent acceleration into the global erectile dysfunction treatment market.
The company has already signed export contracts with about 60 countries and has been focusing on overseas markets.
With the recent approval in Mexico, Chile, and Thailand, CTC Bio has currently expanded its export markets for its erectile dysfunction treatment to 24 countries, including countries such as Turkey, Vietnam, Russia, and Peru.
According to the company, the global market for erectile dysfunction drugs is much larger than the domestic market, as many countries classify such treatments as over-the-counter (OTC) drugs, meaning they can be purchased at pharmacies without a prescription.
Korea's erectile dysfunction drug market, which can only be purchased with a prescription, is also estimated to be around 250 billion won as of 2022.
"Although the approval process varies by country, we are significantly reducing the speed of approval based on our know-how in preparing the necessary documents for approval," a company official said. "As the number of overseas sales licenses increases, we believe it will drive stable sales growth in the human medicine business."
The company also expects to obtain approvals and start sales in more than five additional countries this year, he added.
Meanwhile, CTC Bio has recently completed its phase 3 clinical trial for CDFR0812-15, a premature ejaculation, and erectile dysfunction drug, and plans to apply for product approval in Korea in the first half of this year.
CDFR0812-15, a novel product for premature ejaculation and erectile dysfunction that combines clomipramine (Product: Condencia Tab.), used to treat premature ejaculation, and sildenafil, a treatment for erectile dysfunction.