“First 20,000-Liter Plant Approved in China” … K-CDMOs Face Competition From Both Sides

As China intensifies its pursuit of the global biopharmaceutical contract development and manufacturing organization (CDMO) market, South Korean companies are feeling increasing pressure.

According to a report from the KoreaBIO Bioeconomy Research Center on the 10th, Altruist Biologics, the CDMO subsidiary of China’s Innovent Biologics, obtained a drug manufacturing license from China’s National Medical Products Administration (NMPA) on the 8th. The approval is the first granted to a CDMO manufacturing facility in China equipped with 20,000-liter bioreactors.

Altruist’s Hangzhou facility has four 20,000-liter stainless steel bioreactors. Once the facility is completed, its total production capacity is expected to reach 172,000 liters. The company also operates a 60,000-liter production facility in Suzhou.

As a result, China has added another company with large-scale production facilities alongside WuXi Biologics, which has the world’s second-largest CDMO production capacity after Samsung Biologics. Altruist handles everything from development through commercial manufacturing of antibodies, fusion proteins and antibody-drug conjugates (ADCs).

Amid China’s advances, cooperation between global large-scale CDMOs and South Korean biotechs is also expanding. On March 30, Switzerland-based Lonza signed a manufacturing agreement with ImmuneOncia, a subsidiary of Yuhan Corp., to supply a late-stage clinical candidate for an immuno-oncology drug.

Under the agreement, Lonza will provide drug substance and drug product development and clinical manufacturing services for Danburstotug, a PD-L1-targeted immune checkpoint inhibitor being developed by ImmuneOncia. The drug substance will be produced in Slough, United Kingdom, while the drug product will be manufactured at facilities in Basel and Stein, Switzerland.

The report analyzed that South Korean biopharmaceutical CDMOs have strengthened their global standing, but competition is becoming increasingly intense. It added, “This is a time when efforts are more necessary than ever to increase the trust of existing customers through stable facility operations and to secure new customers by expanding the service base for new modalities.”