Samsung Biologics is moving beyond simple contract development and manufacturing (CDMO) to secure new revenue streams through "platform technology licensing (L/O)" developed in-house. The strategy is to provide customized platforms that overcome the technical limits faced by new drug developers, adding IP-based value to its existing order-driven business model.
Jung Hyung-nam, head of the Bio Research Institute (executive vice president) at Samsung Biologics, held a briefing for Korean reporters on the floor of "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 sales engine."
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Technology transfer using proprietary platforms is a core revenue model for global CDMO corporations. Providing unmatched technology IP raises customers' switching expense, delivering 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 is assessed to enjoy a 15%–20% price premium over general CDMO corporations based on such IP.
By contrast, China's WuXi Biologics holds proprietary platforms such as the bispecific antibody platform "WuXiBody" and the cell line development platform "WuXia," but its market position has wobbled since the passage of the U.S. Biosecure Act late last year. With customers in the United States forced to seek alternative CDMOs, a window has opened for Samsung Biologics to attract their departing clients.
Sensing an opportunity, Samsung Biologics recently launched a "Technology BD Group" and began an all-out platform sales push.
◇ Three flagship platforms including S-DUAL secured, focused on overcoming technical limits
The platforms Samsung Biologics will showcase on the global stage are threefold: ▲ 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 since applied to client volumes.
Bispecific antibodies act simultaneously on different target antigens and offer higher efficacy than monoclonal antibodies, but adding binding sites has raised issues with stability and manufacturing efficiency. Jung said, "To overcome this, we devised an asymmetric structure with one longer arm," adding, "We added a 'CH3 domain' that induces specific binding to minimize mispairing."
He added, "Compared with approved competing drugs by the U.S. Food and Drug Administration (FDA), we saw markedly superior tumor suppression in gastric and breast cancer animal models, with significantly lower immunogenicity."
The ADC payload linker co-developed with new drug development company Aimed Bio, and the BBB shuttle platform that boosts 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, often likened to a "guided missile." Here, the linker ties the antibody and drug together and serves as the connector that controls release only upon reaching the target (cancer cell).
Jung said, "In collaboration with Aimed Bio, we built a linker–payload combination that heightens impact on surrounding cancer cells while reducing side effects on normal cells." The two companies began joint research in 2023 through the "Life Science Fund (jointly formed by Samsung C&T, Samsung Biologics, and Samsung Bioepis)" and unveiled their first result at this event.
The BBB shuttle platform is a technology that delivers therapeutic drugs into the brain by penetrating the tight protective barrier of cerebral blood vessels, and is used in developing new drugs for brain diseases such as Alzheimer's and Parkinson's disease. The company said it has secured a permeation technology that improves toxic side effects seen in competing technologies, such as anemia (red blood cell destruction).
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Still, there is a long way to go before signing deals. Jung said, "For platform technologies, not only efficacy but also toxicity, stability, and pharmacokinetics (PK) data must be fully validated," adding, "We are building data through toxicity tests in non-human primates, so it is premature to pin down a specific timeline."
However, for the BBB shuttle platform, where unmet demand is high, the company plans to respond flexibly, considering market dynamics in which contracts can be signed based on early data alone.
He dismissed concerns about conflicts of interest that "a CDMO corporation might directly develop new drugs and compete with clients." Jung said, "What we develop is support technology that helps clients make better drugs," adding, "Clients retain full ownership of the substances, and we only receive platform license revenue."
Meanwhile, overlap in business domains among the group's bio affiliates remains an issue to resolve.
Samsung Epis Holdings last year launched a subsidiary, "EPIS NexLab," dedicated to discovering new drug candidates, and entered the ADC and drug delivery platform business. As a result, it overlaps in part with the new platform business Samsung Biologics is pursuing, leaving the two organizations effectively fighting separate battles in the same arena.
Some say the two sides have fallen short on role-sharing and prior communication. In response, Jung said, "This is not a structure where we artificially adjust business domains to avoid competition," adding, "If EPIS NexLab needs our platforms in its drug development, it can adopt the technology as one of many potential clients."