Donghoon Lee outlines SK Biopharmaceuticals’ transformation into a global neuroscience player. He discusses the growth of its epilepsy profile, selective expansion into Parkinson’s disease and oncology, and acquisitions. Lee also highlights AI, targeted protein degradation, radiopharmaceutical therapy, and the company’s East–West Bridge strategy, leveraging Korean innovation and its established US clinical and commercial infrastructure.
Could you introduce yourself and your mandate at SK Biopharmaceuticals?
I trained as an accountant at KPMG, starting my career in 1996, and I spent around five years on Wall Street before moving to Hong Kong for three years as a financial adviser and investor, and then returning to Korea to work as a mergers and acquisitions specialist at KPMG. From around 2012 I began advising Korean pharmaceutical businesses specifically, and that is how I came to know the sector well and was eventually recruited by Dong-A Socio Group, one of the largest pharmaceutical companies in Korea, to become chief executive of its holding company. That was 14 years ago, so my career now splits roughly evenly between finance and pharmaceuticals. After six or seven years at Dong-A Socio Group, I received a call from SK Inc., the group’s holding company, inviting me to join as head of investment for the bio sector, and I spent three years there supervising all group investment activity, including SK Biopharmaceuticals, before taking up my current role as chief executive here, where I have now spent four years.
What long-term mandate were you given when you took the role?
I would say there were two mandates. The first concerned our epilepsy medication, which received FDA approval and was launched in the US in 2020, right in the middle of the pandemic. That was an extremely difficult period, as hospitals had largely closed their doors and our sales representatives could not meet physicians face to face. My initial priority was therefore to rebuild the commercial organisation and restore sales momentum. By the end of 2023, we had turned the company into a profitable operation, generating strong and stable operating income ever since.
The second mandate is longer term and focuses on strengthening our research and development capabilities to establish a genuine drug discovery platform in epilepsy and neuroscience. That means modernising what had been a relatively legacy organisation, bringing in external talent, and redesigning our research processes to foster greater innovation. In essence, the first phase was about stabilising and strengthening the commercial business; the second is about building a sustainable engine for future innovation.
SK Biopharmaceuticals built its own US sales force for its epilepsy treatment rather than partnering with a major pharmaceutical company. Why take that route?
That decision predates my time in this role, and was made by my predecessor and by the group’s senior leadership, though I was involved at group level too. We had invested a huge amount of money in developing this medication since the 1990s, and once we finally secured FDA approval, the easier option would certainly have been to work with a large, established pharmaceutical company on a revenue-split basis, and we did receive a number of offers along those lines. But our chairman and our group’s senior leadership chose a different path, because if we had handed sales and marketing over to a partner, we would have received easier cash in return, but we would never have built the expertise or the experience ourselves, and we would have been left with a permanent blind spot. We wanted to remain in this market for the long term and develop further medicines of our own, and while building that commercial platform was very difficult at first, once the system is stable, we can add more drugs on top of it. That was the main motivation for taking on the risk of running our own sales and marketing operation.
Your epilepsy treatment now generates around USD 500 million in US sales. What further growth do you expect, and what has the US market taught you so far?
We are six or seven years into the product’s life, with roughly six years remaining before patent expiry, so we are about halfway through this journey, and there is still a great deal to develop. Prescriptions continue to grow every year, and we are steadily moving into earlier treatment lines: today we are prescribed largely as a third-line therapy or later, but our efficacy data are strong, and we expect to move into second-line use over time. We are also running life-cycle management trials, including expansion into diverse formulations such as oral suspension,, and we are expanding into paediatric use and into primary generalised tonic-clonic seizures (PGTC), on top of our existing approval for adult partial-onset seizures. As those approvals come through, our addressable market should expand considerably, and we remain confident that the treatment can surpass KRW 1 trillion in annual sales as early as next year, and reach blockbuster status in US dollar terms (USD 1 billion) by 2029.
Will the company remain focused on epilepsy, or do you see it expanding into other areas of the central nervous system?
Both, in fact. Epilepsy will remain our first priority, without a doubt, because we have built our commercial platform around it and are confident that we can add further products to that platform in the near future. We talk internally about becoming an epilepsy franchise consolidator, because there are so many different indications and drug types within epilepsy, and we intend to maintain a leading position in that space over time. We have also been actively exploring acquisitions in epilepsy for around three years. As our performance has strengthened, drug development companies with relevant pipelines have become increasingly willing to engage with us, so it has become something of a win-win situation, and we are already in discussions.
At the same time, we have built considerable research and development capabilities and accumulated extensive data and experience over the past 30 years, which we want to leverage selectively in other areas of the central nervous system. Parkinson’s disease is one example, and we currently have a discovery-stage programme under way there. However, this will not be a broad expansion across multiple therapeutic areas. We intend to focus on areas where we believe we have a genuine competitive advantage based on our research capabilities, rather than spreading ourselves too thinly. So the strategy is really twofold: strengthen and consolidate our leadership in epilepsy, while selectively expanding into other areas of neuroscience where we believe we can make a meaningful difference.
Are you agnostic on modality for these newer programmes, or does SK have a natural strength in particular approaches?
We are still in the process of identifying targets, and have not yet decided whether to prioritise by modality or by target type, because there are so many different opportunities available and we prefer to keep our options open for now. We have roughly six years of runway on our existing product, which gives us time, and we would rather remain conservative, because although we have proven we can develop one successful medication, we are not Roche or Bristol Myers Squibb, and we have disciplined capital allocation, so caution matters here. Separately from the central nervous system, we are also developing oncology medicines, a programme we began three years ago, built around two modalities: targeted protein degradation and radiopharmaceuticals.
Asset prices are rising sharply across the sector. What is your acquisition sweet spot, and how do you finance it?
If an asset is already an established blockbuster drug, the price will be very high, often USD three to four billion, and we are not especially interested in that category. Our focus sits at late-stage assets, Phase II or Phase III rather than early pipeline, we are confident we can finance acquisitions at that scale through a combination of internal cash flow and outside funding.
SK Biopharmaceuticals recently announced an agreement to in-license the epislepsy drug candidate opakalim from US biotech Biohaven. How does this fit into the strategy you’ve outlined?
This is a direct expression of what I described earlier, becoming an epilepsy franchise consolidator rather than remaining a single-product company. Opakalim is a late-stage, differentiated candidate targeting the Kv7 channel, and bringing it in-house lets us build directly on the commercial platform we’ve spent years establishing in the US. Once approved, it will let us offer physicians two differentiated medicines rather than one, broadening how we can address unmet needs across the epilepsy population.
It also marks a shift in what kind of partner we can now attract. Three years ago, we were largely evaluating early-stage candidates out of Asian biotechs and US research institutions. Today we’re able to in-license a late-stage, near-term-readout candidate from a publicly listed US biopharmaceutical company. That’s a meaningful marker of how far our credibility and our balance sheet have come.
What are you hoping to gain from your agreement with Insilico Medicine on AI-based screening?
There were really two reasons behind that agreement, signed last June. First, artificial intelligence is clearly becoming a core methodology in modern drug discovery, and Insilico is one of the fastest-moving and most well-established players in the field, with interests closely aligned to our own, making them an excellent partner for that kind of open innovation. Second, going through that process helps us build our own internal capabilities in parallel, and we also benefit from Korea’s genuinely strong pool of technical talent, as well as from our relationship with our parent company, SK Inc., which is deeply committed to artificial intelligence at group level, giving us practical advantages such as securing GPU capacity through the group’s own channels. There is real synergy across all of it.
Why did you choose targeted protein degradation and radiopharmaceuticals for your oncology programme, and are you building these internally or through collaboration?
The rationale differs slightly between the two. For radiopharmaceuticals, the starting point was a group-level relationship: SK Inc, our parent company, entered into a business arrangement with TerraPower, the small modular nuclear reactor company founded by Bill Gates, in which SK Group is the second-largest shareholder following its 2021 investment, and one of the terms of that investment secured us access to actinium-225, a radioisotope used in radiopharmaceutical development. Supply chain and logistics infrastructure matter enormously in this field, as companies such as Novartis have shown, relying on lutetium-177 and building substantial capability around managing that entire supply chain, so having secure isotope access through TerraPower already in place gave us a genuine starting advantage, and it complements our existing strength in small-molecule design. We began this research programme in 2023 and have since licensed in two pipeline assets rather than building everything ourselves: the first, targeting NTSR1, has already had its investigational new drug application filed with the FDA, and its Phase I trial is now under way, while the second targets CA9(Carbonic Anhydrase IX).
Targeted protein degradation (TPD) has a longer history, dating back five or six years to when I was head of investment at group level. We formed a joint venture with Roivant, structured on a roughly 60–40 basis, with Roivant providing the underlying technology and SK providing capital for a five-year early discovery phase, and SK Biopharmaceuticals has since acquired the entire operation outright, so it is now wholly owned by us. Our lead target, designated P300 degrader, should file for investigational new drug status soon.
Given the shifting global landscape, including growing US interest from Chinese, Korean and European companies and developments such as the BIOSECURE Act, where do you see the greatest opportunities for the company?
I would point to three sources of advantage. The first is our group affiliation: we are not a standalone company, and SK Group’s wider portfolio is unusually diverse, spanning semiconductors through SK Hynix, contract development and manufacturing through SK PharmTeco in Sacramento, California, and vaccines through SK Bioscience, so there is real synergy across our three healthcare businesses and the group’s broader initiatives. The second is artificial intelligence, where our chairman’s deep personal commitment at group level gives us considerable support in building an AI-based drug discovery platform, including an ongoing AI-based drug discovery platform collaboration with SK Telecom. The third, as I mentioned, is our established US sales platform, and we are increasingly approached by other pharmaceutical companies, both Korean and Chinese, asking us to handle marketing on their behalf.
We describe our formal strategy here as the East–West Bridge model. “East” means Asian region including Korea, China and Japan, where a great deal of early-stage pipeline research takes place; more than 50 percent of early in-licensing deals into the US, of the kind seen at events such as the J.P. Morgan Healthcare Conference, now originate from China, and we ourselves have a wholly owned operation there. “West” means the US, where we now employ more than three hundred professionals across clinical development and sales and marketing, a scale of infrastructure very few Asian companies have built, aside from a handful of major Japanese names such as Takeda or Otsuka; Chinese companies in particular generally have no sales platform or development team of their own there. That gives us a genuine, if narrow, window of opportunity: we source early pipeline assets and technology from the East, conduct translational research, and then run clinical trials through our established Western platform. We are already approached by early-stage biotech companies in China and Korea on this basis, looking to co-invest and advance their pipelines through US trials, so we feel well positioned to build that bridge in epilepsy and the wider neuroscience space.
Is there a specific advantage to being headquartered in Korea, as distinct from somewhere like Boston?
Our headcount actually splits almost exactly 50-50 between Korea and the United States, which reflects how the business works: early-stage drug discovery happens here in Korea, while clinical trials and sales and marketing activity take place in the US. Given that balance, we prefer not to describe ourselves as either a Korean company or a US company, but as a genuinely global operation drawing on the strengths of both markets.
Is there a final message you would like to convey to our readers?
We are no longer a purely Korean company, and our ambition is to become a genuinely global player in epilepsy, extending well beyond the US through partnerships already in place across Europe, Japan, China, Latin America, Israel, Canada, and Southeast Asia. Our next destination is to become a global epilepsy franchise consolidator, not simply a US-focused one, and our research and development investment strategy will extend globally rather than remaining concentrated in Korea. We are listed here in Korea as a separate, independently listed entity from the wider group, and we believe there is considerable potential for global investors to view us as a genuinely attractive opportunity in our own right.
