Celltrion¡¯s Covid-19 cure passes committee scrutiny; launch expected early Feb.

Kim Si-gyun, Park Yoon-gyun and Minu Kim 2021. 1. 28. 09:45
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[Photo provided by Celltrion Inc.]
South Korea¡¯s first coronavirus cure Rekirona (regdanvimab) by Celltrion Inc. has moved one step closer to marketing authorization that may be granted early next month as the neutralizing antibody therapy passed scrutiny at the Central Pharmaceutical Affairs Review Committee held on Wednesday.

The committee said Rekirona can be used for patients based on the safety and efficacy data submitted, and regulatory approval can be granted subject to submission of Phase 3 trial results later. However, the committee limited target patients to those with moderate symptoms and only high-risk patients with mild symptoms.

The therapy developed by Celltrion is now pending at the Final Review Committee, which is just customary, suggesting that all necessary procedures for approval virtually came to an end, industry sources said.

The latest triumph came after an ad hoc expert panel of the Ministry of Food and Drug Safety recommended marketing approval early last week on condition of a Phase 3 clinical trial.

As a result, Rekirona is expected to be in clinical practice to treat Covid-19 patients ahead of the upcoming Lunar New Year holiday.

During a Monday briefing, Food and Drug Safety Minister Kim Gang-lip said regulatory approval of the treatment is expected to be completed in early February unless there are problems with all review procedures.

Celltrion already finished initial production of Rekirona to cover up to 100,000 patients. The company plans to add Rekirona products for up to 3 million people within this year. Whether the therapy can be offered for free in Korea remains undetermined.

Celltrion shares jumped 1.82 percent to 335,000 won ($300.69) in early morning trade on Thursday, extending gains for the fourth day in a row. Its affiliates Celltrion Pharm and Celltrion Healthcare were trading up 1.34 percent at 196,300 won and 0.92 percent at 154,000 won, respectively.

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