Celltrion will begin commercial production of its investigational COVID-19 antibody treatment (CT-P59) in September and file for emergency use authorization based on positive results from phase 2 trial to speed up its availability, its chief said Monday.
CT-P59 is being developed as a COVID-19 antibody treatment under a national project with the Korea Center for Disease Control and Prevention, and a phase 1 trial of the therapy was approved by the Ministry of Food and Drug Safety last week.
In an online press conference, the company’s chairman Seo Jung-jin said the first phase of the clinical trial will be conducted on 32 volunteers this week.
He anticipated partial commercial production from September before a phase 3 trial to secure data for stable supply and ensure readiness for immediate distribution upon regulatory approval.
Seo said the company is also planning to file for emergency use authorization based on phase 2 trial data if they demonstrate efficacy and safety, adding his goal is to make the drug available within the shortest period of time. This means the phase 2 trial will start in September and commercial supply could begin early next year in a best possible scenario.
Celltrion will allocate 10 batches of commercial production for the antibody treatment out of total 280 batches for full annual capacity at Songdo Plant.
Celltrion plans to recruit 200 to 300 patients for a phase 2 trial and 2,000 to 3,000 patients for third phase in Korea, Europe and Brazil among others.
Seo also said the investigational antibody treatment could be tested in severely ill patients in combination and antiviral drug Remdesivir.
Regarding production volume, he said Celltrion will operate its Songdo facility as much as possible, while consulting with CMO companies for any additional production.
Seo also said he will not create a business model that seeks profit from the COVID-19 treatment, pledging to provide it as cheaply as possible by lowering development and manufacturing costs.
By Kim Byung-ho and Minu Kim
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