Samsung Biologics Co.,Ltd. announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company's track record as a premiere CDO service provider in the global market. In late 2018, National OncoVenture (NOV), a government-funded virtual oncology drug development program in South Korea, approached Samsung Biologics for the development of EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody provided by Eutilex (KOSDAQ:263050). Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade.

Samsung Biologics' CDO business has shown rapid growth and success since its business expansion, signing over 60 CDO contracts within two years to obtain three IND approvals by the FDA as well as one Clinical Trial Application (CTA) approval by the EMA. Leveraging Samsung Biologics' extensive expertise for the submission process, the successful IND was achieved with no further significant comments from the regulatory agency.