[Top 5 Industry News in 2021] Celltrion’s Regkirona wins regulatory green light without a hitch



Although the Covid-19 pandemic persisted throughout the year, the health sector continued to fulfill its duty based on the experiences of the past year. While doing everything to develop treatments and vaccines against Covid-19, the industry has tried to graft new technologies, including AI, to promote the development of the sector. In the process, the industry has revealed issues requiring correction, such as the handling of raw materials and impurities captured in antihypertensive drugs. Yet the sector has continued to improve in line with the evolution of the global health sector amid the Covid-19 crisis. Korea Biomedical Review has compiled the five biggest stories in the industry in 2021. – Ed.

Celltrion’s Covid-19 antibody treatment, Regkirona 960mg (ingredient: Regdanvimab), became the first local Covid-19 treatment to receive an official product license from the Department of Food and Pharmaceutical Safety (MFDS) in September.

Celltrion’s Covid-19 antibody treatment, Regkirona, gained rapid approval from regulators amid great interest and support from the government.

Regkirona selects the neutralizing antibody gene present in the blood of those who have recovered from Covid-19. Subsequently, the company recombined the gene into host cells capable of mass-producing and mass-produced by cell culture. Hospitals can administer the treatment 40 mg per 1 kg of adult body weight intravenously over approximately 60 minutes (± 15 minutes).

Permission to use Regkirona was granted quickly amid government interest and support.

Since the Food and Drug Safety Ministry launched a review at the end of December last year, the regulator approved its “therapeutic use” in January on condition of conducting a phase 3 clinical trial.

With the approval, hospitals have used the treatment for emergency patients in a life-threatening condition or for whom there is no alternative treatment method.

In February, the treatment received conditional approval to treat adult Covid-19 patients confirmed by a polymerase chain reaction (PCR) test who do not have an oxygen saturation greater than 94% inside or do not require additional oxygen supply, and high-risk patients with mild to moderate severity who developed symptoms within seven days before administration.

In August, Celltrion submitted a report on the results of the global Phase 3 clinical trial for Regkirona to the Ministry of Food and Pharmaceutical Safety. The ministry granted formal approval for the treatment the following month.

During this period, the ministry also broadened the target of administration from patients over the age of 60 or mild patients with underlying diseases (cardiovascular disease, chronic respiratory disease, diabetes and hypertension) to patients over the age of 50. years and people with obesity (BMI over 30), chronic kidney disease (including dialysis), chronic liver disease and immunocompromised patients (cancer treatment or bone marrow transplant) in the range of underlying conditions.

The ministry also confirmed that Regkirona has excellent efficacy, as shown by a statistically significant reduction in worsening severity due to symptoms of Covid-19 and clinical recovery period.

According to the MFDS, in the high-risk group treated with Regkirona, the incidence of severe cases fell by 72% compared to the placebo group. In addition, the improvement time of clinical symptoms was also shortened by more than 4.12 days.

With the recent wave of Covid-19 infections after the government implemented its ‘living with Covid 19’ program, the Korea Disease Control and Prevention Agency (KDCA) has broadened the scope of institutions that can use Regkirona from infectious disease medical centers or hospitals to elderly care facilities, general hospitals, living treatment centers, and acute and outpatient treatment centers.

On December 15, the Cabinet meeting approved the KDCA plan to set aside 299.2 billion won ($ 252 million) to purchase additional treatments for Covid-19. With the approval, the agency plans to spend 192 billion won to buy oral Covid-19 medicine and 107.2 billion won to buy Remdesivir and Regkirona.



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