Samsung Biologics is moving beyond simple contract development and manufacturing (CDMO) to secure a new revenue stream through "platform licensing (L/O)" based on its own technologies. The strategy is to provide a customized platform that overcomes the technical limits drug developers face and add IP-based added value to its existing order-centric business model.
Jung Hyung-nam, head of the Bio Research Institute (executive vice president) at Samsung Biologics, held a briefing for Korean reporters at Bio USA in San Diego, California, on the 24th (local time) and said, "Like our competitors, we will develop and export our own platform technologies and make them a new revenue driver."
◇ "20% premium" Lonza and "biosecurity law hit" WuXi… Samsung eyes market reshuffle
Technology transfer leveraging in-house platforms is a core revenue model for global CDMO corporations. By offering differentiated technology IP, client switching expense rises, yielding a strong lock-in effect.
Notably, Switzerland's Lonza has built an IP portfolio spanning the entire biopharmaceutical process, including the mammalian cell line development platform "GS System" and the bispecific antibody platform "bYlok." According to investment bank Jefferies, Lonza enjoys a 15%–20% price premium over general CDMO corporations based on this IP.
By contrast, China's WuXi Biologics owns its proprietary bispecific platform "WuXiBody" and the cell line development platform "WuXa," but its position has been shaken since the passage of the U.S. biosecurity law late last year. As clients in the United States find themselves needing to seek alternative CDMOs, a window has opened for Samsung Biologics to capture departing customers.
Sensing an opportunity, Samsung Biologics recently created a Technology BD (business development) group and launched a full-scale platform sales push.
◇ Three flagship platforms including S-DUAL secured, with a focus on overcoming technical limits
Samsung Biologics will showcase three platforms on the global stage: ▲ the bispecific antibody platform "S-DUAL," ▲ an antibody-drug conjugate (ADC) payload linker, and ▲ a blood-brain barrier (BBB) shuttle platform. The most advanced is S-DUAL, launched in 2022 and already applied to client batches.
Bispecific antibodies act simultaneously on different target antigens and are more potent than monoclonal antibodies, but adding binding sites has raised issues with stability and manufacturing efficiency. Executive Vice President Jung said, "To address this, we designed an asymmetric structure with one longer arm," adding, "We added a 'CH3 domain' that induces specific pairing to minimize mispairing."
He added, "Compared with existing competitor drugs approved by the U.S. Food and Drug Administration (FDA), it showed markedly superior tumor suppression in gastric and breast cancer animal models and significantly lower immunogenicity."
The ADC payload linker co-developed with ADC new drug corporation Aimed Bio, and the BBB shuttle platform that improves delivery of drugs for intractable brain diseases, are also moving to secure substantive demand.
ADCs are new drugs that attach a toxic drug (payload) to an antibody that targets only cancer cells and are often likened to "guided missiles." The linker ties the antibody and drug together and controls release so the drug separates only upon reaching the target (cancer cells).
Executive Vice President Jung said, "In collaboration with Aimed Bio, we built a linker–payload combination that heightens the bystander killing effect on neighboring cancer cells while reducing side effects on normal cells." The two companies began joint research in 2023 through the Life Science Fund (Samsung C&T, Samsung Biologics, and Samsung Bioepis jointly formed) and unveiled the first results at this event.
The BBB shuttle platform is a technology that delivers therapeutic drugs into the brain by penetrating the dense defensive barrier of cerebral blood vessels, and is used in new drug development for brain diseases such as Alzheimer's and Parkinson's disease. The company said it has secured a permeability technology that improves on toxic side effects seen with competing technologies, such as anemia (red blood cell destruction).
◇ "We won't develop new drugs" line drawn, but intra-group coordination remains
Still, there is a long way to go before signing deals. Executive Vice President Jung said, "For platform technologies, not only efficacy but also toxicity, stability, and pharmacokinetics (PK) data must be fully validated," adding, "We are building datasets through toxicity studies in nonhuman primates, so it is premature to pin down a specific timeline."
However, for the BBB shuttle platform, where unmet need is high, the company plans to respond flexibly, considering the market's tendency to close contracts based on early data.
The company drew a line against concerns about conflicts of interest that "a CDMO corporation might directly develop new drugs and compete with its clients." Executive Vice President Jung said, "What we develop is support technology that helps clients make better new drugs," adding, "Clients fully retain ownership of the substances, and we only earn platform license revenue."
Meanwhile, overlapping business areas among the group's bio affiliates remain an issue to resolve.
Samsung Epis Holdings last year established a subsidiary, EPIS NexLab, dedicated to discovering new drug candidates, and entered the ADC and drug delivery platform businesses. As a result, parts of the new platform business pursued by Samsung Biologics now overlap, putting the two organizations in a position of fighting separate battles in the same arena.
Some say the two sides have fallen short on role-sharing and prior communication. In response, Executive Vice President Jung said, "We are not artificially adjusting business domains to avoid competition," adding, "If EPIS NexLab needs our platforms during its new drug development, it can become a client that adopts our technology, as one of many potential customers."