Rekkirona Injection Efficacy Controversy Dismissed... Celltrion Advocates 'Vaccine Sovereignty'

Seo Jeong-jin directly refutes various allegations
Expresses determination to develop vaccine

On controversy over mild symptom efficacy
"Virus reduction and clinical time reduction
both show the same effectiveness"

Celltrion's COVID-19 antibody treatment 'Rekkironaju' (Provided by Korea Disease Control and Prevention Agency)

[Asia Economy Reporters Jihee Kim and Chunhee Lee] Seo Jung-jin, Honorary Chairman of Celltrion, refuted various allegations raised regarding the company’s COVID-19 antibody treatment ‘Rekkironaju (CT-P59)’, which has begun supply to medical institutions, dismissing controversies over its efficacy. He emphasized that responses to the emerging diverse antibodies are already underway and expressed a willingness to actively engage in vaccine development if unavoidable.

Importance of Vaccine Sovereignty... Considering Direct Development

Seo Jung-jin, Honorary Chairman of Celltrion, is speaking at an online press conference on the company's COVID-19 antibody treatment 'Rekkironaju (CT-P59)' on the 18th. (Provided by Celltrion)

At an online press conference on the morning of the 18th, Honorary Chairman Seo stated, "We will not leave the public defenseless against variants," indicating continued development of treatments for variant viruses as well as a willingness to develop vaccines. He repeatedly stressed the need for preemptive measures, mentioning ‘technological sovereignty’ and saying, "Relying on imports delays response to variant viruses by six months to a year."

Regarding vaccine development, Seo said, "Creating antibodies means being able to produce antigens," and added, "Considering the issue of technological sovereignty in COVID-19 vaccines, if we cannot achieve technological independence, we are contemplating whether we need to enter the vaccine industry."

He explained, "We are prepared to make vaccines," but clarified, "It’s not that we want to make COVID-19 vaccines per se, but if we need to produce bivalent or trivalent vaccines in response to future variants and supply to South Korea is delayed, then we must do so." He continued, "Although it is not a profitable business, if necessary for national technological independence, we are ready to proceed urgently without concern for profitability," and added, "We hope to secure vaccine sovereignty first."

With global pharmaceutical companies reportedly starting development of vaccines for COVID-19 variants, this statement is interpreted as a readiness to enter vaccine development should South Korea fall behind.

"Rekkironaju’s Efficacy Is Sufficient"

Celltrion's COVID-19 Antibody Treatment 'Rekkironaju' Supply Plan (Source: Celltrion)

Currently, Rekkironaju has completed Phase 2 clinical trials and is conducting Phase 3 trials aimed at reducing hospitalization and oxygen therapy due to worsening symptoms in COVID-19 patients.

Celltrion provided detailed explanations regarding the clinical trial results so far. Kim Seong-hyun, Head of Clinical Planning at Celltrion, said, "In previous clinical results, the incidence rate was not high, so it may appear statistically insignificant," adding, "The goal of Phase 3 is to demonstrate statistical significance with a large patient population, so please consider this."

Regarding the efficacy in mild patients, which was the biggest controversy during the approval process, Kim stated, "Both viral reduction effects and clinical time reduction effects were observed equally in mild patients," but noted, "However, whether this effect is economically viable for younger patients without underlying conditions can be evaluated differently."

On this day, Celltrion also actively refuted other controversies surrounding Rekkironaju. Concerning the antibody-dependent enhancement (ADE) phenomenon, where neutralizing antibodies might instead facilitate viral infection, Honorary Chairman Seo strongly denied, saying, "ADE is a phenomenon related to dengue virus, not COVID-19," and "It has not been reported in relation to COVID-19 so far." Kim also responded, "ADE occurs only under specific conditions," adding, "Neither Celltrion nor other companies have observed ADE side effects, and it was thoroughly checked through cell and animal experiments before clinical trials."

Regarding price controversies, Seo emphasized repeatedly that "only necessary raw materials, employee wages, and essential costs were included," indicating supply at ‘manufacturing cost’ level. However, he refrained from disclosing detailed pricing, citing "export issues" and stating, "The government will not disclose it either." He also dismissed allegations of preferential treatment.

This content was produced with the assistance of AI translation services.