Peptron wins Korea nod for long-acting Takeda challenger in prostate cancer, early puberty

Peptron has landed Korea’s first marketing approval for a domestically developed leuprolide treatment, positioning the biotech to take on Takeda’s blockbuster Lupron in prostate cancer and precocious puberty, the medical term for early puberty.

The drug, Leupone, is a once-monthly injection built on Peptron’s SmartDepot platform, which enables sustained release of peptide therapies. It’s also the company’s first commercial product to be fully self-manufactured.

According to Peptron, Leupone is the only leuprorelin product in Korea to show full bioequivalence to Lupron, matching both clinical outcomes and pharmacokinetics. No other generic outside Japan has met this standard, despite Lupron’s three-decade dominance of the category.

The approval clears the way for domestic rollout under an exclusive partnership with LG Chem, which will handle sales and distribution while Peptron leads manufacturing. 

LG Chem’s existing dominance in pediatric endocrinology with its growth hormone drug Eutropin is expected to provide a strategic edge in the precocious puberty segment.

Peptron said Leupone also stands out for its smaller particle size, reduced injection gauge, and extended shelf life of up to 36 months, offering advantages in ease of use and supply chain efficiency.