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Celltrion(338,500 -2.59%)Announced that CT-P59 (ingredient name regdanvimab), an antibody treatment for novel coronavirus infection (Corona 19) under development, also works on mutant viruses. The company is ready to submit clinical results. It plans to apply for conditional approval this week. The treatment is expected to be available as early as February next year.
Celltrion Group Vice Chairman Woo-sung Ki made the announcement at the ‘2020 Korea Bio Investment Conference (KBIC)’, which opened on the 28th at Dragon City, Hangang-ro, Seoul. At this event co-hosted by the Korea Bio Association and the Korea Economic Daily, Vice Chairman Ki said, “Celltrion has finished preparing to apply for conditional approval from the Ministry of Food and Drug Safety for CT-P59.” “The conditional approval application will be made within this year.” Said.
Celltrion has been analyzing safety and efficacy data after completing phase 2 clinical administration of CT-P59 last month. It is currently in the production stage of the treatment. Celltrion has produced 100,000 prescriptions to shorten the time until the actual prescription.
Celltrion’s antibody therapy is aimed at treating mild patients. The goal is to prevent organ damage, a factor leading to severe disease, through early diagnosis and early treatment. “Corona 19 virus reaches its maximum detection level within a week after infection,” said Vice Chairman Ki. “CT-P59 is expected to reduce the progression to severe patients by focusing on early treatment for mild patients.” did.
In particular, he emphasized, “We have confirmed that CT-P59 actually works even with the mutated Corona 19 virus.”
Celltrion plans to apply for a conditional license within this year and then to apply for a formal product license next year.
It is also planning to increase manufacturing facilities for the production of antibody therapeutics. Vice Chairman Ki said, “Celltrion plans to expand the 3rd plant (60,000 liters) following the existing 1st factory (100,000 liters) and 2nd factory (90,000 liters).” (CAPA) will be increased to 390,000 liters.”
He said, “Next year, we will operate one factory so that only Corona 19 treatment can be produced.”
Celltrion reiterated that it will invest a total of 40 trillion won, including 25 trillion won for biopharmaceuticals, 5 trillion won for chemicals, and 10 trillion won for’U-Healthcare’, by 2030 as a mid- to long-term strategy to directly and indirectly employ approximately 110,000 people.
Vice Chairman Ki said, “We will launch at least one biopharmaceutical every year by 2030. We plan to establish a direct sales network outside of Russia, China, India, the Middle East and Africa, and sell them directly to Canada in 2021 and the United States in 2022.” did. He added, “The number of chemical drugs will increase from 56 this year to more than 80 products annually.”
Reporter Kim Ye-na [email protected]
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