Peptron said Friday its prostate cancer and precocious puberty therapy has won designation as an investigational new drug from the Ministry of Food and Drug Safety.
The company plans to start clinical trials of its pipeline, PT105, in March and complete them by September. It will then submit the non-disclosure agreement and launch the new drug into the market in the second half of 2022.
PT105 is long-acting prostate cancer therapy lasting for one month, developed by its original platform, SmartDepot technology. It has an identical component to Leuplin from Takeda Pharmaceutical Co., a blockbuster drug with sales of 53 billion won ($48.2 million) in 2019.
Peptron established a mass-production process, improving drug particles’ size, significantly advancing convenience for drug administration, it said.
Peptron expects the drug to have high competitiveness because it can reduce patients’ pain using 26 gauge instead of thick gauge shots, one of the disadvantages of the existing product.
Researchers will conduct the clinical trial using a cross-over (two by two) method in Chungnam National University Hospital in Daejeon to test PT105’s efficacy and safety compared to Leupliln.
“We expect PT105 produced in Osong Biopark GMP factory will become a steady seller for the company, and enter the global market as a first generic pharmaceutical with the same pharmacokinetics profile of the original product,” a Peptron official said. “We have completed the selection of preferred bidder for a local licensing agreement,” the official added.