Celltrion researcher (Celltrion)
With the daily number of new COVID-19 cases surpassing 1,000 for the first time Sunday, South Korea’s bet on the most feasible exit plan from the mayhem is treatments, not vaccines.
While both vaccines and treatment may be needed to extinguish the pandemic for good, so far for Korea, treatments are making quicker advances to actual use on people here.
National household names Celltrion and GC Pharma are inches away from acquiring conditional use permits from local health authorities, according to industry insiders.
Both companies plan on applying for the permit within this year or early next year at the latest. Celltrion’s antibody treatment is targeted for use on COVID-19 patients with light symptoms, and GC Pharma’s plasma treatment is meant for seriously afflicted patients with underlying diseases.
A conditional use permit allows a drug still under development to be preemptively used to cope with emergencies at the medical forefront. It is a more sweeping free pass than a therapeutic use permit, which is applied individually by hospitals wishing to use the treatment.
Rep. Lee Nak-yon, chief of the ruling Democratic Party, said Sunday that he expects treatments using the locally produced drugs to begin sometime next month on a large scale.
“We’re trying to deliver treatments (for widespread use) before late January and vaccines before March,” he told a press conference.
The former prime minister said he had reason to believe that would be possible. “I am presenting this time frame from what I learned so far and with a bit of will to make that happen.”
On Friday, Celltrion’s antibody treatment CT-P59 acquired its first therapeutic use permit for Asan Medical Center in Seoul.
CT-P59, according to Celltrion Chairman Seo Jung-jin, eliminated the coronavirus within four to five days in a phase 1 clinical trial targeting 18 lightly affected COVID-19 patients.
Having completed the administration of the drug in the ensuing phase 2 clinical trial, targeting 327 patients spread around the globe, Celltrion is counting down to apply for a conditional use permit from the Ministry of Food and Drug Safety as soon as it analyzes the study results from the phase 2 trial.
Celltrion Chairman Seo had pledged to give out the treatment at no margin to local patients. The company has enough stock of the drug for 100,000 people, for immediate distribution upon approval from the Drug Ministry.
GC Pharma researcher (GC Pharma)
GC Pharma’s plasma treatment GC5131A is another potent pipeline that is almost at the brink of a permit application.
GC5131A as of Sunday has therapeutic use permits at 21 hospitals in the country, and has produced a full recovery in a seriously ill patient in his A hospital’s request for a therapeutic use permit for a new drug indicates the futility of previously known treatments, a GC Pharma official explained to The Korea Herald.
GC Pharma plans to finish analyzing the data from its clinical phase 2 trial between year-end and early next year to expedite use of GC5131A throughout Korea by early 2021.
GC Pharma President Huh Eun-chul promised from the early phase of the research that the company would provide the treatment for free.
Being a plasma treatment, the only limitation GC5131A has is that it is difficult to mass-produce. To make GC5131A, GC Pharma needs continued plasma donations from people who have contracted the virus and fully recovered. These people can repeatedly share plasma in two-week cycles, GC Pharma said.
GC Pharma is currently receiving blood from 45 national blood donation centers.
“The increased number of COVID-19 patients, in this case, works favorably to a stable supply of raw plasma,” explained the official.
Other than GC Pharma and Celltrion, pharmaceutical companies such as Chong Kun Dang and Daewoong Pharmaceuticals are also making steady progress toward repurposing pancreatitis treatments nafamostat and camostat as COVID-19 drugs.
On the vaccine frontier, Korea has forged deals for enough vaccine doses to cover 44 million people here, but the shots will only be doled out sometime next year.
Through individual deals with global companies the government has procured doses for 34 million people from AstraZeneca-Oxford University, Pfizer-BioNTech, Moderna and Janssen. The country will get doses for an additional 10 million people from the global COVAX facility, whose vaccine supply will come from Pfizer, AstraZeneca and Sanofi-GSK.
By Lim Jeong-yeo (email@example.com