NewG Lab Pharma to Produce and Supply Anticancer Drug Raw Materials for Yuhan Corporation

[Asia Economy Reporter Hyunseok Yoo] NewG Lab Pharma's U.S. subsidiary will receive active pharmaceutical ingredients (APIs) from Korea's top pharmaceutical company Yuhan Corporation, stabilizing the supply chain not only for the currently ongoing clinical trial of the anti-metastatic cancer drug but also for mass production of the drug for future sales.

NewG Lab Pharma announced on the 13th that its U.S. subsidiary, NewG Lab Pharma, Inc., has signed a Master Service Agreement (MSA) with Yuhan Corporation for the production of APIs for the anti-metastatic cancer drug and is preparing for test batch production.

Until now, clinical trial APIs have been produced through Sigma-Aldrich, part of the global pharmaceutical company Merck Group in Germany, but this time, a domestic supply source has been secured.

NewG Lab Pharma explained that the reason for selecting Yuhan Corporation as the domestic supply chain is to ensure smooth progress of the clinical trials of the anti-metastatic cancer drug KAT (Ko Anti-cancer Technology) and to respond to future demand for the drug by selecting multiple Contract Manufacturing Organizations (CMOs) specializing in biopharmaceuticals.

In particular, since KAT can be applied to all cancer types, the APIs supplied by Yuhan Corporation can be used not only for the FDA-approved liver cancer Phase 1+2a clinical trials but also for clinical trials and production of the drug for other cancer types in the future, according to the company.

A NewG Lab Pharma official stated, “Although we have been reliably producing APIs through Sigma-Aldrich of the Merck Group, we have now signed a contract with Yuhan Corporation, which has the best facilities and personnel domestically. Through this contract, we have diversified our API procurement sources and established a foundation to stably manufacture clinical trial drugs and commercial drugs.”

The APIs will be produced by Yuhan Chemical, a subsidiary of Yuhan Corporation. Established in 1980, Yuhan Chemical supplies world-class APIs to domestic and international pharmaceutical companies. Yuhan Chemical’s cGMP manufacturing facilities and quality control systems have been certified by pharmaceutical advanced countries such as the U.S. FDA, European EDQM, and Japanese PMDA.

Additionally, Yuhan Corporation was recently selected as one of the “Top 10 CMOs in the Asia-Pacific Region in 2021” by the global pharmaceutical media PHARMA TECH OUTLOOK, recognizing its global competitiveness in the synthetic drug field.

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