Peptron Receives Marketing Authorization in Mexico for Prostate Cancer Treatment

Peptron has received marketing authorization for Loop One® (PT105), a treatment for prostate cancer and precocious puberty, from Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS).

According to Peptron on Nov. 9, Loop One® is a once-monthly injection containing leuprolide. It is the first commercialized product to use Peptron's proprietary drug-delivery platform, SmartDepot™. Designed to release the drug continuously over a set period, it can maintain its efficacy over the long term.

In particular, the product has demonstrated bioequivalence (BE) to the original Japanese product and, for the first time outside Japan, has also demonstrated pharmacokinetic (PK) equivalence to standards used in developed countries. Leuprolide is a representative hormone therapy used to treat a range of conditions, including precocious puberty and prostate cancer.

Peptron received domestic marketing authorization for Loop One® in July 2025 and has since been gradually expanding the commercialization of its internally developed medicines in Korea and overseas. Following this authorization, the company is moving forward with the procedures required to supply and sell the product in Mexico and seeking business partnerships to ensure a stable market entry. The authorization also lays the groundwork for expanding into Latin American markets, with further market growth expected.

A Peptron official said, "This authorization in Mexico is significant because it lays the groundwork for the overseas expansion of a commercialized product featuring our proprietary SmartDepot technology. Having achieved commercialization milestones overseas following domestic marketing authorization, we will continue to pursue expansion into global markets, including Latin America, to ensure a stable supply of the product to local markets."

This content was produced with the assistance of AI translation services.