Peptron Obtains European Medicines Agency GMP Certification for Osong Bio Park Factory

Peptron Osong Plant.

[Asia Economy Reporter Lee Gwan-joo] Peptron announced on the 14th that it has obtained the EU GMP QP certification from the European Medicines Agency for the clinical drug production of 'Prisendin,' a treatment for idiopathic intracranial hypertension (IIH) jointly developed with Australian company Invex.

Peptron's Osong Bio Park plant, which received the certification, is a smart sustained-release peptide drug clinical development and production-commercialization facility with a total floor area of 4,700㎡. It is specialized for injectable finished drugs in the new drug development pipeline and can produce up to 1 million vials annually.

Australian company Invex was established by researchers from the University of Birmingham in the UK, who led the world's largest IIH clinical trials, to develop treatments. They confirmed the strong clinical efficacy of the GLP-1 peptide and received orphan drug designation under the product name Prisendin in the US and Europe, currently preparing for Phase 3 clinical trials for approval.

Peptron will continuously supply the drugs needed for the global clinical trials, which will proceed for about two years, through its Osong GMP facility. Additionally, clinical trials will be expanded not only to Europe and Australia but also to the US, with plans to soon apply for the US FDA Investigational New Drug (IND) approval.

CEO Choi Ho-il stated, “Our core technology, the 'Smart Depot' technology, has proven to be the world's most advanced commercialization technology by successfully achieving mass production and meeting the quality standards of developed countries for sustained-release drugs.” He added, “Building on this, we will do our best to achieve early results for innovative new drugs under development using this technology, including those for degenerative brain diseases, as well as sustained-release drugs for new drugs from multinational pharmaceutical companies.”

This content was produced with the assistance of AI translation services.