[Click e-Stock] "Peptone Completes Validation of Smart Depot Platform"

On July 16, Shinhan Investment Corp. analyzed Peptone, stating that the company "has completed validation through the commercialization of its sustained-release technology." The firm did not provide a separate investment opinion.

Um Minyong, a research analyst at Shinhan Investment Corp., said on this day, "Peptone received product approval from the Ministry of Food and Drug Safety, which is a result achieved by only a select few among big pharma companies such as AstraZeneca, Sanofi, and Ipsen." LoopOne is a generic drug for the treatment of prostate cancer, uterine fibroids, and precocious puberty, replicating Lupron (active ingredient: leuprorelin), the original once-monthly medication from Takeda Pharmaceutical of Japan.

LoopOne was introduced in May 2025. By leveraging its proprietary technology, Peptone achieved a release pattern similar to Lupron, with an initial rapid release over 24 hours followed by sustained release for one month.

Um emphasized, "LoopOne is the only product in Korea to demonstrate bioequivalence, as it met the criteria of having its Cmax (maximum plasma concentration) and AUC (area under the curve) within the 80?125% confidence interval compared to the original. It also offers a competitive advantage in pain reduction due to its significantly thinner needle diameter compared to competitors."

He further stated, "This approval by the Ministry of Food and Drug Safety for LoopOne validates the sustained-release Smart Depot Platform technology. The fact that the main ingredient, leuprorelin, is a peptide, along with Peptone's in-house R&D, its own manufacturing plant, and clinical capabilities, as well as the change from a once-weekly to a once-monthly formulation, are all factors that open up the possibility of expanding into multiple obesity and MASH treatments, including those currently being co-developed with Lilly."

LG Chem holds the domestic marketing rights for LoopOne and is expected to launch the product between September and October 2025. With domestic approval, Peptone is discussing licensing rights for approximately 30 countries, including Korea and Japan, with multiple pharmaceutical companies. Um added, "Preparations are underway to enter the global LoopOne competitor drug market, which is valued at about $1 billion (1.3 trillion KRW), and construction for the plant that will manufacture both LoopOne and Lilly samples is also progressing smoothly. As a result, expectations for a formal contract remain high."