Samsung Biologics Signs Expanded CMO Contract with TG Therapeutics for Ublituximab

Samsung Biologics and TG Therapeutics CI (Provided by Samsung Biologics)

[Asia Economy Reporter Chunhee Lee] Samsung Biologics announced on the 26th that it will expand the contract manufacturing organization (CMO) volume of the monoclonal antibody therapeutic agent Ublituximab (TG-1101) with the US biopharmaceutical company TG Therapeutics.

Through this announcement, Samsung Biologics corrected the previously announced CMO order amount for Ublituximab from 24.13296 billion KRW (22.4 million USD) in December 2019 to approximately 54.1057 billion KRW (50.3 million USD), an increase of about 30 billion KRW. The contract amount ratio to sales also rose from 8.19% to 18.36%. In the earlier announcement, Samsung Biologics had only disclosed the contracting party as a "US-based pharmaceutical company" citing "business confidentiality."

The contract amount is a confirmed minimum guaranteed amount, and if TG Therapeutics succeeds in developing Ublituximab, the amount is expected to increase to 278.12 million USD (approximately 299.1 billion KRW). Furthermore, if customer demand increases in the future, it is expected to rise up to 345.62 million USD (approximately 371.6 billion KRW).

This is the fourth CMO contract between Samsung Biologics and TG Therapeutics. Since signing the first CMO contract for Ublituximab in February 2018, the two companies have maintained close collaboration and continuously expanded the CMO volume through successive contracts.

Ublituximab, a treatment for multiple sclerosis, is currently designated as an orphan drug by the US Food and Drug Administration (FDA) and is undergoing Phase 3 clinical trials.

Michael Wise, Chairman and CEO of TG Therapeutics, said, "We are pleased to collaborate with Samsung Biologics, a global leader in pharmaceutical manufacturing, at a time when the commercialization of Ublituximab is anticipated." He added, "Following positive results from the recent Phase 3 clinical trial, we recalculated the required volume, and thanks to Samsung Biologics, we have secured long-term manufacturing capacity to meet the expected global demand for Ublituximab."

John Rim, CEO of Samsung Biologics, stated, "Through facility investments, we have been able to flexibly respond to customer demands and improve customer satisfaction. We will become a company that contributes to a better life for humanity by providing timely treatment to multiple sclerosis patients worldwide."

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