Peptron, Inc. announced on November 17 that it has successfully established bioequivalence of "PT105," once-a-month injectable Leuprolide for the treatment of prostate cancer, breast cancer, endometriosis, and precocious puberty. Takeda's Leuplin, the original drug for PT105, is one of the biggest blockbuster drugs that has achieved a total of $1.34 billion in sales and the global market share over the past 30 years. Material, Composition and Use patents have expired, but Peptron obtains full equivalence due to the difficulty in generic drug development of emulating Takeda's manufacturing process and technology.

Peptron aims to enter into the domestic and global market with 1-, 3- and 6-month formulations of generic Leuprolide. In August 2022, Peptron and Invex Therapeutics received phase 3 IND approvals from the U.S. FDA, MHRA and others for Presendin (PT320). Currently, there is no treatment available for idiopathic intracranial hypertension (IIH), the main target of Presendin, and the global market size of IIH is approximately $1.5 billion USD.

Peptron expects a significant revenue potential and increased demands in contract development and manufacturing services. Peptron aims to enter into the domestic and global market with 1-, 3- and 6-month formulations of generic Leuprolide.