SOUTH KOREA — SK Bioscience has obtained product approval for its flu vaccine, Sky Cellflu, from Chile’s health authorities, the first green light in a Latin American (LatAm) country, the South Korean vaccine developer has said.

South Korean biotech company, SK Bioscience, has shifted its focus from the COVID-19 vaccine, SKYCovione, and developed a growth strategy to navigate the challenging global economic climate.

As a crucial part of this strategy, SK is resuming the production of its flu vaccine, SKYCellflu, which was temporarily set aside during the pandemic.

The company has received regulatory approvals from multiple countries including Malaysia, Thailand, the Philippines, Myanmar, Iran, Singapore, Pakistan, Mongolia, Brunei, and most recently Chile.

This latest approval from Chile’s health authorities marks the first in a Latin American country and further solidifies the vaccine’s global reach.

Starting with Chile, SK Bioscience is planning to expand the number of countries licensed for Sky Cellflu in Latin America.

Chile’s drug approval is widely considered a regional standard among Latin American countries, the company added.

SKYCellflu is a game-changer in the world of flu vaccines, being the first cell culture-based vaccine of its kind.

According to the company, this innovative technology allows for much faster production times compared to traditional fertilized chicken egg-based influenza vaccines.

This speed of production is crucial in responding to pandemics or the emergence of new variants.

Furthermore, the vaccine is safe for individuals with egg allergies or anaphylaxis as it is produced in aseptic incubators without the use of antibiotics or preservatives.

The vaccine has also obtained WHO Pre-Qualification certification and leads the flu vaccine market in Korea, accounting for 29 percent of local sales as of 2020, according to the firm’s press release.

SK Bioscience CEO Ahn Jae-yong said, “Sky Cellflu’s production will resume this year, and will expand its scope beyond the Korean market based on its proven product competitiveness.”

“As our status as a global vaccine company has grown through the pandemic, various vaccines developed by SK Bioscience will become famous overseas,” he added.

SK Bio’s post-covid strategy

SK Bioscience has outlined its plans for the future, as the COVID-19 pandemic moves into an endemic stage.

The company is focusing on the development of a combination COVID-19/flu vaccine candidate and is also working on a vaccine candidate for the entire Sarbecovirus group.

This will provide a broader protection system against COVID-19 variants and SARS in the future.

In addition to its flu vaccine, SK has plans to roll out its SKYVaricella varicella vaccine, which is already being supplied to Latin America via an order from the Pan American Health Organization (PAHO).

The company is also looking to expand and secure technologies in the cell and gene therapy (CGT) business through mergers and acquisitions, joint ventures, and partnerships, such as its recent agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a new mRNA vaccine platform.

Under this agreement, SK will receive up to US$140 million in R&D expenses to support phase 1/2 clinical trials of two mRNA vaccine platform projects.

SK Bioscience aims to raise its vaccine R&D and production infrastructure to a global level, despite the difficult internal and external business environment.

“We are implementing a business strategy to meet the expectations of stakeholders,” said Ahn when the new strategy was announced.

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