Progress of Celltrion Corona Antibody Treatment in Europe

Prime Minister Jeong Sye-gyun visits Incheon Celltrion Plant 2, which is developing an antibody treatment for a novel coronavirus infection (Corona 19) on the 22nd, and listens to the explanation of the treatment from Celltrion Chairman Seo Jeong-jin. 2020.12.22 [사진=연합뉴스]

Celltrion(298,000 +5.67%)On the 25th, the European Medicines Agency (EMA) launched the’Rolling Review (sequential examination)’ of the Corona 19 antibody treatment’Recyronazu’ (ingredient name Legdanvimab CT-P59), for product approval in Europe. It said that a formal review process has begun.

EMA’s Rolling Review is a system used by the EMA-affiliated Drug User Advisory Committee (CHMP) to accelerate the evaluation of promising treatments or vaccines in crisis situations such as pandemics. It is a method of receiving data and documents on the efficacy, safety, and quality of drugs in real time before the final approval application and reviewing them quickly.

Celltrion has already submitted quality and manufacturing process controls, non-clinical and clinical trial data to EMA in order to expedite global approval of Rekirona. CHMP begins evaluating the efficacy and safety of Rekirona based on various data submitted by Celltrion.

Celltrion has conducted preliminary consultations with major global regulatory agencies such as the European EMA and the US Food and Drug Administration (FDA) to proceed with the rapid approval process after the completion of the global phase 2 clinical trial in Rekkirona. In particular, in recent years, we have had specific discussions with EMA to initiate a rolling review.

Celltrion said it is preparing to quickly supply medicines as soon as the approval process for Rekirona is completed overseas. It has already completed the production of Rekkirona for 100,000 people, and plans to produce additional 1.5 to 3 million people annually depending on demand.

It has also begun preparations to respond to the corona 19 mutant virus that may occur in the future. Currently, it is developing a cocktail treatment that combines candidate antibody No. 32, which has neutralizing ability in British and South African mutants, and Rekirona. It is conducting phase 3 clinical trials on 1,200 mild and moderate corona19 patients in 10 countries around the world.

An official from Celltrion said, “The licensing process for European supply has been in full swing. As preliminary consultations are currently underway with major countries in the world, various data and documents requested by each country’s regulatory agencies have been submitted without disruption to provide early supply to Rekkirona. I will do my best for that.”

Reporter Kang Kyung-joo [email protected]

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