Anygen, a peptide bio-material specialized company, announced on the 26th that the Ministry of Food and Drug Safety (MFDS) visited its Osong plant, a site for peptide development including obesity and infertility treatment drugs, and held a meeting.
The plant visit and meeting were attended by Park Yoon-joo, Director of MFDS, Kim Young-rim, Head of the Pharmaceutical Review Department, personnel from the Advanced Pharmaceutical Quality Review Division, as well as 20 development managers from domestic and international companies including Novo Nordisk, Johnson & Johnson, Astellas Pharma, Janssen, Daewon Pharmaceutical, Yuhan Corporation, Huons, Korea United Pharm, and Regeninopharm.
According to the company, during the visit to Anygen’s Osong plant, Director Park Yoon-joo and MFDS officials highly evaluated the company as the only domestic manufacturer of peptide active pharmaceutical ingredients (APIs) leading the development of peptide medicines.
At the meeting, discussions were held on the current status of synthetic peptide guidelines and major challenges. The MFDS stated, “To support new drug development applying advanced technologies, we are proactively establishing a regulatory system based on scientific knowledge, including developing quality evaluation guidelines for synthetic peptide pharmaceuticals.”
Director Park Yoon-joo said, “If there are any points where regulatory improvements are needed during the development and commercialization of synthetic peptides, please let us know anytime. The MFDS will always listen closely to the development sites and actively work to resolve issues.”
An Anygen official said, “Anygen’s Plant 1 (Jangseong) and Plant 2 (Osong) are specialized peptide manufacturing plants, and they are highly regarded by pharmaceutical companies and regulatory agencies for their outstanding peptide production capabilities. For the smooth growth of the domestic peptide industry, it is necessary to have guidelines at the level of advanced countries such as the US, Europe, and Japan, as well as development programs to support peptide drug development. We are working closely with the MFDS to address this.”
Anygen’s Osong plant independently undertakes contract manufacturing of domestic and international peptide clinical drugs and has established the manufacturing process for the diabetes and obesity peptide therapeutic ‘AGM-217.’ Currently, non-clinical toxicity tests are underway in Japan.
Anygen plans to complete non-clinical animal testing of ‘AGM-217’ in 2025 and obtain IND approval for Phase 1 clinical trials from the MFDS in the latter half of 2025. Additionally, for Ganirelix, an infertility treatment peptide API approved by the MFDS in 2023, the company plans to submit a Drug Master File (DMF) to the US Food and Drug Administration (FDA) this year to enter the global pharmaceutical market. Currently, Anygen is reviewing the pharmaceutical DMF data together with Interchem in the US.
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