[Reporter’s View] K-BIO needs strength to go the distance

It needs the endurance to finish the race

New drug development is a war of capital.

 

The amount of money and time required to develop a drug candidate, push it through clinical trials, and finally reach approval is beyond imagination.

 

It is widely known that developing a single new drug typically takes 10–15 years and costs KRW 1–2 trillion.

 

When developing high-complexity modalities such as antibody–drug conjugates (ADCs) or bispecific antibodies, the initial R&D cost grows exponentially.

 

This is why biotechs inevitably rely on early-stage technology out-licensing models.

 

Without a revenue base, it is difficult to independently conduct late-stage clinical trials that require hundreds of billions to trillions of won.

 

As a result, secure preclinical or early clinical data and quickly move to out-license the technology.

 

For drug development biotechs, technology transfer is not a choice but a survival strategy.

 

But recently, a shift is emerging.

 

Rather than out-licensing technologies at early stages, some leading biotechs are now moving to carry their core pipelines into late-stage clinical trials themselves.

 

LigaChem Bio, which strengthened its capital base after Orion Group became its largest shareholder, has declared plans to push certain ADC pipelines into late-stage clinical trials independently.

 

ABL Bio, which signed two major licensing deals with global big pharma this year alone, has also indicated its intention to take its key pipeline into late-stage trials on its own.

 

This trend is noteworthy as it signifies that domestic companies are moving into a phase where they directly secure control over new drug development.

 

Under the traditional licensing model, the fate of development was effectively handed over the moment the license was transferred.

 

If the partner changed strategy or de-prioritized the project, the original developer had no way to intervene or revive it.

 

Conversely, by directly advancing into late-stage clinical trials, the company itself can determine the value and direction of the new drug.

 

The decision to take a pipeline into late-stage development is also a major shift in terms of corporate value.

 

Licensing deals grow larger the further the pipeline progresses.

 

While early-stage technology exports typically result in contracts worth tens to hundreds of billions of won, the contract size jumps to at least hundreds of billions of won, and can reach trillions of won, by the time late-stage clinical trials commence.

 

Behind the decision to “carry it all the way through” lies the calculation that taking on additional risk is worth it if it means the results and rewards remain with the company.

 

Above all, the attempt to directly navigate through to the late-stage clinical phase holds significant meaning in terms of accumulating the ‘core know-how involved with new drug development’ that Korea has been lacking.

 

Under the license-out-centric structure, most late-stage experiences determining a drug's success—such as Phase 2b/3 trials, global regulatory strategies, FDA meetings, and commercialization preparation—were largely ceded to overseas partners.

 

The recent move by some companies to take their pipelines through late-stage clinical trials into their own hands holds value in internalizing the experience and know-how that previously flowed overseas, thereby elevating Korea's drug development capabilities to the next level.

 

Technology exports remain necessary and will continue to be a vital survival strategy.

 

However, companies aiming to compete on the global stage should resolve to “see at least a few pipelines through to the end.” While not every biotech company can conduct late-stage clinical trials directly, simply accumulating one or two more companies with ‘full-cycle experience’ will undoubtedly elevate the standing of Korea's biotech sector.

 

May technology transfer become not the final destination for survival, but the starting point toward completing the full cycle.