logo
#

Latest news with #currentGoodManufacturingPractice

Celltrion nears US plant deal to go ‘made in USA'
Celltrion nears US plant deal to go ‘made in USA'

Korea Herald

time29-07-2025

  • Business
  • Korea Herald

Celltrion nears US plant deal to go ‘made in USA'

Biosimilar giant to invest W700b in new US plant, double spending for expansion, chief says Celltrion Group Chairman and founder Seo Jung-jin said Tuesday that the company is preparing for new US tariffs by moving closer to acquiring a biologics manufacturing facility in the United States -- a move that would give Celltrion greater access to a market Seo framed as 'indispensable.' According to a regulatory filing Tuesday, Celltrion has been named the preferred bidder for a large-scale biologics manufacturing facility in the US, a cGMP or "current Good Manufacturing Practice" drug substance site located within a major pharmaceutical hub. The seller and deal value remain under wraps pending final agreement, expected in early October. 'The US is simply too big a market to walk away from, and we're aiming to eliminate uncertainty in our US sales,' said Seo during a livestreamed press conference Tuesday. 'If the US government wants drugs to be made in the US, then our plan is to produce them there accordingly.' Celltrion currently sells 11 biosimilars in the US, with plans to expand its portfolio to 22 by 2030 and 41 by 2033. It is also conducting Phase 1 trials for four novel drug candidates this year, with the goal of submitting investigational new drug applications for a total of 13 by 2028. Once due diligence is complete and the acquisition finalized, Celltrion is set to largely eliminate tariff-related risks for its pharmaceutical products in the US, backed by two years' worth of US-bound inventory and expanded contracts with local contract manufacturers. The deal includes a contract manufacturing agreement covering 50 percent of the facility's capacity, granting exclusive rights to produce the seller's biologics for five years. 'That means we won't be operating at a loss from day one,' Seo continued. 'The other half will be used to manufacture our own products for the US market.' He added that the potential acquisition brings a team of development personnel, which would complement Celltrion's existing research capabilities. Celltrion is also considering follow-up investments depending on how US tariff policies take shape. While the total cost of acquiring and operating the facility is expected to reach roughly 700 billion won ($503 million), Seo said a minor expansion could require an additional 300 billion won. 'In the case of a large-scale buildout, we estimate up to 700 billion won in extra investment,' he said. The expanded facility would be up to 1.5 times the size of Celltrion's second plant in Songdo, Incheon, he added. While highlighting the cost and time advantages of acquiring an existing facility, Seo noted that competition would likely remain limited due to high capital requirements and long lead times for local production. 'We believe US drug prices are likely to rise, and for companies that complete local production early, this could be a major opportunity,' he noted. As for the sales outlook, Seo said the company is on track to deliver 4.5 to 4.6 trillion won in sales this year -- of Celltrion's five trillion won full-year goal -- with operating profit expected to reach about 1.5 trillion won. In the second quarter, Celltrion posted record revenue and operating profit, with revenue rising 9.9 percent from a year earlier to 961.5 billion won and operating profit jumping 234.5 percent to 242.5 billion won.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store