[Edaily Reporter Hong Ju-yeon ] The reasons why Korea’s pharmaceutical and biotech industries are turning their attention to space lie in cost and sovereignty. In a microgravity environment, the costs and time required for new drug development can be significantly reduced. As a result, space is emerging as a stage for “sovereign potential”—a platform where Korea can independently develop new drugs without relying on external technology—going beyond being merely a space for experimentation. There is a growing consensus that domestic space biotech companies are rapidly catching up to the path paved by global Big Pharma giants such as Merck and Eli Lilly over the past nearly 10 years.

Launches, Investments, Research…

Domestic Companies Entering the Space-Based Pharmaceutical Race

A report on trends in innovative biopharmaceutical technologies utilizing the space environment, published this month by the Korea Health Industry Development Institute, noted that while South Korea started later than major developed nations in the space pharmaceutical and biotech sectors, it successfully began conducting actual space experiments starting last year. The report added that the pace of catching up could be accelerated by utilizing proprietary modules, satellites, and unmanned automated experiments.

Space Lintech is cited as the domestic company leading the charge in catching up with global Big Pharma. Last August, Space Lintech successfully sent South Korea’s first space pharmaceutical research module, BEE-PC1, to the International Space Station (ISS) aboard a SpaceX Falcon 9 rocket. BEE-PC1 is an automated protein crystallization platform designed to automatically monitor the protein crystal growth process without astronaut intervention. Analysts note that this achievement is significant because it demonstrated the ability to produce high-purity, highly homogeneous protein crystals through an automated process even in a microgravity environment.

Last November, Space Lintech LTD. successfully launched South Korea’s first cube satellite dedicated to space biotechnology, Bicheon (BEE-1000), aboard the Nuri Rocket No. 4. This pharmaceutical research module is currently conducting automated crystallization experiments on pembrolizumab, the active ingredient in the immunotherapy drug Keytruda. This is believed to be the first time in the world that the crystallization of a protein-based drug has been conducted on a CubeSat platform.

In this regard, observers note that this marks a shift from relying on large-scale infrastructure like the International Space Station (ISS) for space-based new drug research to a repeatable model utilizing small satellites. Following two satellite launches last year, Space Lintech is aiming for a total of three launches this year, including the fifth Nuri rocket launch. Next year, that number will increase to eight. As launch frequency increases and costs decrease, Space Lintech aims to begin full-scale commercialization starting next year.

Boryung(003850)It is also regarded as a leading player that has aggressively made equity investments to secure a foothold in the space healthcare ecosystem. Boryung is the only domestic pharmaceutical company to have declared space medicine as a core corporate growth strategy. Boryung made a full-scale entry into space medicine in 2022 by investing a total of $60 million (approximately 80 billion won) in Axiom Space, a U.S.-based commercial space station developer.

Subsequently, in January 2024, it established BRAX Space (Boryung 51%, Axiom Space 49%), a space joint venture with Axiom Space. Through this venture, Boryung secured exclusive domestic business rights to utilize low-Earth orbit infrastructure, laying the groundwork for the development of new drugs to treat conditions such as cancer and aging.

Boryung’s acquisition of this space station infrastructure is viewed as having created a practical gateway for major domestic institutions and companies to utilize private space stations. Furthermore, Boryung is expanding its business scope to the Moon by making a $10 million (approximately 15.4 billion won) equity investment in Intuitive Machines, the first U.S. company to develop a commercial lunar lander. In this way, Boryung is pursuing a strategy focused on securing access to global space infrastructure and fostering an ecosystem.

Donga ST(170900) Its subsidiary, Aptis, is developing antibody-drug conjugates (ADCs) using antibodies produced in space environments, with government support. Aptis is carrying out a project under Korea’s “ARPA-H Project,” led by the Korea Health Industry Development Institute. The ARPA-H Project aims to solve national healthcare challenges through mission-oriented research and development (R&D) that, while costly and technically challenging, has significant ripple effects.

The area in which ApTis is participating is the development of innovative medical technologies in space medicine to overcome medical challenges, with the development of new drugs in the space environment identified as a key focus. ApTis is responsible for the production, optimization, and evaluation of new antibody-drug conjugate (ADC) drug candidates using antibodies produced in the space environment.

In academia, a research team from Hallym University is conducting research on 3D bioprinting and stem cell differentiation in space by deploying the “Bio-Cabinet”—a payload for space biology research—on the Next-Generation Medium-Sized Satellite No. 3. Both commercial demonstrations by companies and basic research by academia are simultaneously turning their attention to space.

The Remaining Challenge Is the “Ecosystem”… Securing Regulatory Standards Is Key

To ensure these achievements are not one-off events, building an industrial ecosystem is considered crucial. The key lies in transforming one-off space experiments into a repeatable research infrastructure. Key tasks include international validation of experimental results, establishing a system for continuous on-board experiments, forming a domestic space biotech consortium, developing a space CDMO ecosystem, and laying the groundwork for the regulatory use of space experiment data.

Regulation is identified as the biggest variable. Technically, it is possible to manufacture pharmaceuticals in space. However, approval from the U.S. Food and Drug Administration (FDA) has not yet been granted. Against this backdrop, the British government recently became the first in the world to propose a regulatory pathway to support companies manufacturing pharmaceuticals in space.

Through interagency cooperation, the UK aims to establish a clear regulatory pathway so that pharmaceuticals developed and produced in space can be used to treat actual patients. It plans to review the safety, quality control, and approval procedures for space-produced pharmaceuticals to refine the relevant regulatory framework. The UK is targeting clinical approval for space-manufactured drugs by 2028.

In South Korea as well, discussions have begun with the Ministry of Food and Drug Safety (MFDS) and KOREA AEROSPACE INDUSTRIES (KASA). The biotech industry is suggesting that the MFDS establish a dedicated organization for space biopharmaceuticals and proactively propose an agenda for Good Manufacturing Practice (GMP) standards for space-manufactured drugs, arguing that South Korea must position itself as a nation that sets regulatory standards. Given that the United States and Europe are leading regulatory discussions, early participation in standard-setting is essential to securing a leading position in the future market.

Ultimately, the core of the domestic biotech industry’s expectations for space lies in “sovereignty”—the capability to develop, operate, and control such technologies independently.

Space Lintech is focusing on the field of rare diseases. Until now, major pharmaceutical companies have been reluctant to develop treatments for rare diseases due to low profit margins relative to investment costs. However, with advancements in space technology and artificial intelligence (AI), if the cost of new drug development drops to one-tenth of current levels, domestic pharmaceutical companies will also be able to embark on new drug development at a lower cost.

Yoon Hak-soon, CEO of Space Lintech LTD., said, “Areas such as rare diseases—which until now could only be addressed by global Big Pharma due to the financial burden—could become viable business models for domestic pharmaceutical companies as well,” adding, “Once domestic companies acquire the capability to independently develop new drugs, they can achieve ‘Sovereign’ status in the pharmaceutical sector.”

He added, “We expect that a foundation will be established to independently develop and supply medicines of national importance, such as vaccines, from space.”