NewG Lab Completes Contract for Outsourced Production of Anticancer Agent Daeha

[Asia Economy Reporter Hyunseok Yoo] Newgelab announced on the 3rd that its U.S. subsidiary Newgelab Pharma, which is engaged in the development of new anticancer drugs targeting metabolism, has completed a CDMO (Contract Development and Manufacturing Organization) contract with the U.S. UIP (The University of Iowa Pharmaceuticals) for the production of finished pharmaceuticals.

In line with the principle of operating multiple CDMOs in Europe and the U.S., Newgelab Pharma also signed a similar contract last year with AMRI, a global pharmaceutical company based in the U.K.

As a result, the anticancer drug KAT (Ko Anticancer Therapeutics) under development by Newgelab Pharma can now be produced as a finished pharmaceutical product at global CDMO companies equipped with production facilities that meet EU-GMP and cGMP standards.

The finished pharmaceuticals for clinical trials will be manufactured respectively by AMRI (Albany Molecular Research, Inc.) and UIP. AMRI is a global CDMO company with pharmaceutical production facilities that meet EU-GMP and cGMP standards across 19 sites in 9 countries in the U.S., Europe, and Asia. The finished pharmaceutical production facility for KAT is located in Glasgow, U.K.

UIP is a pharmaceutical company affiliated with the University of Iowa in the U.S. It has over 40 years of experience in pharmaceutical production with facilities that meet cGMP standards. It is also the largest and most experienced university-affiliated pharmaceutical company registered with the U.S. Food and Drug Administration (FDA).

cGMP is the FDA’s Good Manufacturing Practice and quality control standard that must be followed to ensure the safety and efficacy of pharmaceuticals. EU-GMP is the Good Manufacturing Practice standard of the European Medicines Agency (EMA). Both UIP and AMRI have strict quality control standards covering everything from raw material procurement to the entire production process, including manufacturing facilities.

Shinyoung Han, Head of Clinical Division at Newgelab, said, "The production of the active pharmaceutical ingredient for KAT, a representative anticancer drug, is handled by Sigma-Aldrich. With the completion of this contract, we have fully established a production system from the active pharmaceutical ingredient to the finished pharmaceutical product."

The anticancer drug KAT is one of Newgelab’s key anticancer pipelines and works by blocking the metabolic process of cancer cells, effectively starving and killing only the cancer cells. Its efficacy has been confirmed in various cancer types including liver cancer, breast cancer, bladder cancer, and melanoma, and it has numerous treatment cases involving actual patients.

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