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BioWorld - Friday, April 17, 2026
Home » Celltrion Inc.

Articles Tagged with ''Celltrion Inc.''

Celltrion-Regkirona-2-9

Celltrion COVID-19 therapy significantly lowers patient risks in phase III study

June 14, 2021
By Michael Fitzhugh
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
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Hand holding dollar sign

Iksuda advancing lead ADC to the clinic with $47M series A financing

June 7, 2021
By Nuala Moran
LONDON – Iksuda Therapeutics Ltd. sealed its transition from technology licensing company to antibody-drug conjugate (ADC) development specialist, closing a $47 million series A financing to move the lead program, IKS-03, into the clinic.
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Phlebotomist draws blood from patient

Celltrion wins European approval for ELISA COVID-19 test kit

May 3, 2021
By Gina Lee
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
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New COVID-19 therapy trials ramp up as weekly cases surpass previous peaks

April 29, 2021
By Michael Fitzhugh
Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to evaluate treatments aimed at keeping people from progressing to worsened disease and reports on two new variant-focused efforts yielding signs of preclinical promise.
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Product packaging for Diatrust COVID-19 Ag Rapid Test

Celltrion takes rapid COVID-19 test kit to U.S. on the back of FDA EUA

April 21, 2021
By Gina Lee
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
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Celltrion-Regkirona-2-9

Celltrion wins first conditional Korean approval for COVID-19 antibody Regkirona

Feb. 9, 2021
By Gina Lee
HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.
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Vials on production line

Celltrion shares positive phase I results and plans for anti-COVID-19 antibody CT-P59

Nov. 10, 2020
By Gina Lee
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
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Vials on production line

Celltrion shares positive phase I results and plans for anti-COVID-19 antibody CT-P59

Nov. 9, 2020
By Gina Lee
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
Read More
Vials on assembly line

Celltrion gets nod for additional CT-P59 indication

Oct. 13, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
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Vials on assembly line

Celltrion gets nod for additional CT-P59 indication

Oct. 12, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
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