[Top 5 Industry News in 2021] Celltrion’s Regkirona wins regulatory nod without a hitch – Korea Biomedical Review

Although the Covid-19 pandemic persisted throughout the year, the healthcare industry continued to fulfill its duty based on experiences of last year. While going all out to develop Covid-19 treatments and vaccines, the industry tried to graft new technologies, including AI, to promote the sector’s development. In the process, the industry revealed problems requiring correction, such as manipulating raw materials and impurities caught in antihypertensive drugs. Still, the sector continued to improve itself in keeping with the changing global healthcare industry amid the Covid-19 crisis. Korea Biomedical Review has compiled the five biggest industry stories in 2021. — Ed.

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

Celltrion’s Covid-19 antibody treatment Regkirona won swift approval from regulators amid high interest and support from the government.

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

The permission to use Regkirona was made swiftly amid the interest and support of the government.

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

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

In February, the treatment received conditional approval to treat adult Covid-19 patients confirmed through polymerase chain reaction (PCR) test who do not have an oxygen saturation exceeding 94 percent indoors or does not require supplemental 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 global phase 3 clinical trial results for Regkirona to the Ministry of Food and Drug Safety. The ministry granted official approval for the treatment the following month.

During that time, the ministry also expanded the target of administration from patients older than 60 years of age or mild patients with underlying diseases (cardiovascular disease, chronic respiratory disease, diabetes, and hypertension) to patients over 50 years of age and obese people (BMI index greater than 30), chronic kidney disease (including dialysis), chronic liver disease, and immunosuppressed patients (cancer treatment or bone marrow transplant) in the range of underlying conditions.

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

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

With the recent surge of Covid-19 infections after the government implemented …….


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