Korean pharmas may turn into global vaccine makers on Biden remarks

South Korea’s biosimilar and pharmaceutical companies are looking at a growing chance of emerging as a global hub for manufacturing vaccines following US President Joe Biden’s support for waiving patents of COVID-19 vaccines.

On Wednesday, Biden threw his support behind temporarily waiving intellectual property rights for COVID-19 vaccines, a move he said would allow developing countries to produce the life-saving vaccines until world leaders can get the pandemic under control.

Drugmakers such as Pfizer and Moderna opposed the idea, saying such a move could disrupt a fragile supply chain and that rich countries should instead share more generously with the developing world.

However, if adopted by the World Trade Organization (WTO), the proposal would invite new bio and pharma manufacturers to mass-produce coronavirus vaccines to help facilitate the end of the pandemic.

According to industry officials on May 7, the latest development offers Korean biosimilar firms and pharmaceutical companies a decent opportunity to become global leaders, given their strong manufacturing capabilities and global-scale production facilities.

HOME TO WORLD’S TOP CMO FACILITIES

Korea is already home to the world’s leading contract drug manufacturers, including Samsung Biologics Co. that makes a COVID-19 medicine for Eli Lily & Co., an American pharmaceutical firm.

Under a scheme known as a contract manufacturing organization (CMO), another SK Group affiliate, SK Bioscience Co., has been producing British-Swedish pharmaceutical giant AstraZeneca plc’s COVID-19 vaccine since September 2020. It also inked a contract development and manufacturing organization (CDMO) order for a coronavirus vaccine candidate developed by US-based Novavax Inc. last year.

“If the IP protection of COVID-19 vaccines is removed, SK Bioscience can immediately produce the two vaccines in large quantities and bring them to the market,” said a CMO company official.

Other major Korean companies with huge CMO capabilities include Green Cross Corp. (GC), Isu Abxis and Hankook Korus Pharm.

According to Binder Dijker Otte (BDO), an international network of public accounting, tax, consulting and business advisory firms, Korea’s CMO production capacity is the world’s second-largest with 385,000 liters following the US, the global leader with a capacity of 486,000 liters.

If the American CMO firms run out of capacity, Korea stands next in line for receiving orders from pharmaceutical companies, analysts said.

Like many other US bio startups, Moderna does not have its own production facilities and focuses only on the research and development of vaccines and biopharmaceutical products.

In May, Moderna entered a 10-year agreement with Lonza Group AG, a Swiss biotech company, for large-scale manufacture of its vaccine products. Under the deal, Moderna will use Lonza’s facilities in the US and Switzerland to produce mRNA vaccines.

CLINICAL TRIALS OF VACCINES

A Korean CMO firm’s chief executive said Celltrion Co. and Samsung Bioepis Co., the world’s two largest biosimilar companies, will play a bigger role in the mass-production of replica medicines when the IP protections of COVID-19 vaccines are over.

Earlier this year, Seo Jung-jin, founder and honorary chairman of Celltrion, said the company is considering tapping into the vaccine development market.

According to Korea’s Ministry of Food and Drug Safety, five biopharmaceutical companies are currently conducting phase I and II clinical trials of their COVID-19 vaccine candidates. They are SK Bioscience, EuBiologics Co., Cellid Co., GEnexine Inc. and GeneOne Life Science Inc.

RECOMBINANT PROTEIN VACCINES

Analysts said if global players’ vaccine protection rights are lifted, Korean companies could accelerate the development of their own products.

Industry officials said Korean companies would likely prefer developing a recombinant protein vaccine over the mRNA type.

The mRNA vaccine, employed by Pfizer and Moderna, is a type that uses a copy of a natural chemical called messenger RNA to produce an immune response, while the recombinant protein vaccine injects fragments of viral proteins into the human body as antigens, a method used in flu and hepatitis B vaccines.

“It won’t be easy for Korean companies to develop their own mRNA technology. It may take at least a year for them to produce such vaccines in large quantities,” said a Korean CMO company representative.

Write to Woo-Sub Kim and Yong-Seok Ju at duter@hankyung.com
In-Soo Nam edited this article.