Celltrion is attempting to enter the United States and Europe and other global markets through the antibody treatment drug’Recyrona (ingredient name Regdanvimab)’ for a novel coronavirus infection (Corona 19).
As the European Medicines Agency (EMA), a European licensing agency, is known to have initiated a full-fledged review, interest is drawing on the report card that Celltrion will receive in the second quarter.
Celltrion, which received conditional approval for the Corona 19 antibody treatment Rekyrona in Korea in February last year, is making concrete plans to supply Rekirona not only in Korea but also overseas.
In particular, it is aiming to enter the global market centering on the US and Europe, and is currently knocking at the US Food and Drug Administration (FDA) and EMA.
At the online press conference held on the 18th of last month, Celltrion Chairman Seo Jeong-jin explained the progress of global advancement, saying, “The two organizations are currently in the preliminary screening stage.”
Among them, EMA has begun a detailed review process since last month. According to Celltrion, the European Medicines Agency (EMA) initiated a review process on the 2nd (local time) to provide expert opinions to European countries that want to introduce Rekirona early.
Scientific opinion on whether Rekirona can be used by a group of experts from the Drug User Advisory Committee (CHMP) under the EMA so that individual European countries can make a decision to introduce them through the’Compassionate Use Program’, etc. Present.
EMA plans to verify whether Rekirona can reduce the rate of severe development as a treatment for COVID-19 and reduce the rate of visits and hospitalizations in intensive care facilities. In order to be verified, Celltrion has submitted the data of the Rekkirona Global Phase 2, which is the basis for the conditional approval in Korea.
Separately, Celltrion also entered the procedure for formal item approval in Europe last month. CHMP began evaluating the efficacy and safety of Rekirona on the 24th of last month. Earlier, Celltrion submitted quality and manufacturing process control, non-clinical and clinical trial data to EMA.
Celltrion plans to accelerate the product approval period through’Rolling Review’. Rolling Review is a system used by CHMP to accelerate the evaluation of treatments or vaccines in crisis situations such as pandemics. First of all, it is a method of reviewing.
However, Celltrion did not talk about the expected timing of entry into Europe. A Celltrion official said, “It is difficult to ascertain a specific expected timing.”
The industry predicts that it will take about 1 to 2 months to release the opinions of CHMP experts in light of the earlier cases of approval for emergency use of antibody treatments by Eli Lilly and Regeneron by country in Europe.
The financial industry looked positively at the results of Rekkirona’s global expansion.
In the report, Hana Financial Investment predicted that Celltrion’s performance will improve significantly through Rekkirona’s global advancement.
Hana Financial Investment Researcher Seon Min-jeong, who wrote the report, said, “If you succeed in entering the US or European markets where the number of patients is high and drug prices are set high, Rekirona’s sales are expected to be large enough to be incomparable with existing biosimilars. ”He expressed his view.
Celltrion also revealed that it plans to additionally produce 1.5 to 3 million people per year for the global supply of Rekirona, depending on demand.
However, as critics about’economics’ such as the efficacy versus cost of Rekirona targeting mild patients in Korea continue, Celltrion’s’knock’ for entering Europe is expected to become a watershed for verifying Rekirona’s efficacy and sales.