Korean drugmakers close to commercializing COVID-19 vaccine, pill

South Korea’s biopharmaceutical companies are close to commercializing a COVID-19 vaccine and treatment pill as they are on the brink of completing their final rounds of clinical trials.

SK Bioscience Co, the drug-making unit of South Korea’s SK Group, said on Monday it has confirmed the positive results of phase 3 clinical trials of its COVID-19 vaccine candidate GBP510.

The company said its tests on 4,037 adults aged 18 and older conducted for eight months from last August in Korea and five other countries, including Thailand, New Zealand and Ukraine, demonstrated immunogenicity superiority compared to Vaxzevria, the control vaccine jointly developed by Oxford University and AstraZeneca plc.

SK said it will submit a biologics license application to the Korean Ministry of Food and Drug Safety this month and expects approval by the end of the first half.

If approved, GBP510 will become Korea’s first COVID-19 vaccine.

"Through the successful development of GBP510, we will create a turning point in global quarantine measures," SK Bioscience Chief Executive Ahn Jae-yong said. "We will also do our best to help Korea establish itself as a nation with vaccine sovereignty."

GBP510 is a COVID-19 vaccine candidate jointly developed by SK Bioscience and the Institute for Protein Design (IPD) of the University of Washington under a project funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

Separately, SK is producing COVID-19 vaccines under contract development and manufacturing organization (CDMO) programs for its two global pharmaceutical clients – AstraZeneca and Novavax Inc.

COVID-19 TREATMENT PILL

Meanwhile, Shionogi & Co., a Japanese pharmaceutical company developing COVID-19 treatment S-217622 jointly with Korea’s Ildong Pharmaceutical Co., said the drug has shown rapid efficacy against the coronavirus in tests.

The pill, S-217622, "demonstrated rapid clearance of the infectious SARS-CoV-2 virus," Shionogi said in a statement.

Industry officials said the pill has fewer side effects and is easier to take than Pfizer Inc.’s COVID-19 pill Paxlovid.

While a COVID patient must take a total of 30 Paxlovid pills over five days for treatment, tests showed one S-217622 pill a day over five days has the same effect, according to the officials.

Shionogi has global aspirations for the antiviral pill, which is now being evaluated by Japanese regulators.

Ildong Pharmaceutical also plans to seek sales approval from Korea’s drug administration once Shionogi gets the go-ahead from Japanese regulators.

The Korean company plans to manufacture the pill at its local plant after a technology transfer from Shionogi.

Write to Ji-Hyun Lee at bluesky@hankyung.com
In-Soo Nam edited this article.