Anigen Submits Application for Approval of Ganirelix Active Pharmaceutical Ingredient for Infertility Treatment to US FDA

Anygen, a peptide bio-material specialized company, announced on the 21st that it has submitted a Drug Master File for the active pharmaceutical ingredient (API) of 'Ganirelix' to the U.S. FDA (Food and Drug Administration) for ANDA approval.

Ganirelix is a generic injection of 'Ogarutran (Ganirelix Acetate)' by the U.S. pharmaceutical company MSD, used as an early ovulation suppressant in infertility treatment. Ganirelix is used to prevent the premature surge of luteinizing hormone (LH) in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technology. Currently, the infertility treatment market size is $5.8 billion (approximately 7.7 trillion KRW) in the U.S. and 26 billion yuan (approximately 4.7 trillion KRW) in China.

Anygen has been developing the product to commercialize Ganirelix and obtained the only domestic product approval from the Korean Ministry of Food and Drug Safety in December last year. Following domestic approval, Anygen has been preparing the FDA product approval application in collaboration with its U.S. partner to expand into the global market.

An Anygen official stated, “Ganirelix contains specific amino acids, and we produce it using our excellent peptide production technology and yield improvement methods. Compared to the market size, there are few peptide manufacturers worldwide capable of producing Ganirelix.” He added, “After approval, based on the reliability secured through FDA approval and the scarcity of the raw material, it is expected that Anygen will achieve significant results in the U.S. market through its API sales business and contract development and manufacturing organization (CDMO) business.”

Anygen CEO Kim Jae-il said, “Anygen is a specialized peptide hormone manufacturing company and has succeeded in domesticating the Ganirelix API, a small and medium-sized enterprise research project, to actively participate in the government’s infertility treatment support project.” He continued, “In infertility clinics, peptide therapeutics ‘Leuprorelin’ and ‘Ganirelix’ are used sequentially, and since Anygen has both treatments, it is expected to increase sales in the infertility market while responding to the government’s efforts to solve the low birthrate problem.”

Meanwhile, in addition to API production and supply, Anygen is conducting non-clinical toxicity tests of the diabetes and obesity peptide therapeutic ‘AGM-217’ through a Japanese CRO. The company plans to complete non-clinical animal testing in 2025 and proceed with human clinical trials in 2026.