Celltrion, South Korea’s leading biosimilar developer, said it doubled its efforts to create a super-fast test kit designed to identify COVID-19 and to develop a cure, which the company foresees would reach human clinical trial stage within six months.
Seo Jung-jin, Celltrion’s Chairman, shared on a YouTube live stream on Thursday the group’s ongoing efforts on the coronavirus cure development. He said that the company aims to commercialize the kit within three months with a local partner.
Seo said that under normal circumstances, the process would take about 18 months, though, given the emergency in South Korea, they plan to initiate the use of antibodies on confirmed patients after six months. Celltrion would closely work with the Ministry of Food and Drug Safety to conduct the trials.
Celltrion secured a blood sample from a recovered coronavirus patient released from the Seoul National University College of Medicine. The company has also been gathering more samples from other institutes to use for screening antibodies required for the diagnostic kits. The biosimilar developer hopes to narrow down the antibody candidates by the end of March and select the most potent pipeline by the end of April.
The chairman said that as they are developing a cure, they would also develop diagnostic kits that can be used by people without the intervention of a medical professional.
Hospitals widely use a method called quantitative reverse transcription PCR (RT-qPCR), but it takes a few hours to acquire results with very high accuracy. Meanwhile, a rapid diagnostic kit works faster but has low accuracy.
Celltrion intends to combine both methods benefiting from their advantages. The company plans to create a kit that could show results within 15 to 20 minutes with high accuracy.
Seo added that the company plans to conduct a phase 1 study to demonstrate safety, and a phase 3 trial for both safety and efficacy and side effects in up to 1,000 patients.
Furthermore, Celltrion would provide a total of 1 million masks to citizens of Cheongju, North Chungcheong Province, and Incheon, Gyeonggi Province. Both cities are where Celltrion’s operation facilities are located, said Seo.
Seo said that the commercial development of the new coronavirus treatment would cost at least $248.8 million (300 billion).
“We are doing this so that Korea will become an exemplary case for eradicating COVID-19.”
– Celltrion Chairman Seo Jung-jin, during the YouTube live stream
Celltrion is still pursuing to establish China’s biggest biologics drug plant in the city of Wuhan.