Sam Chun Dang Pharm drew market interest by presenting a blueprint to overseas investors to develop Keytruda, the world's top-selling cancer drug, into an oral pill, but some say its substance needs to be verified.
MSD, which owns Keytruda, said talk of developing an oral formulation was "groundless," and it turned out the key data the company presented were only placeholders, prompting calls for investor caution.
On the 22nd, according to the pharmaceutical and biotech industry, Sam Chun Dang Pharm held a non-deal roadshow (NDR) for overseas investors, including in Hong Kong and Singapore, on the 8th to 9th, and then on the 11th conducted an investor relations (IR) session for individual shareholders.
Sam Chun Dang Pharm laid out a roadmap to pursue commercialization and licensing-out of formulation-switch products that convert Keytruda into an "oral drug," and a "subcutaneous (SC) injection," leveraging its in-house drug delivery platform technology (S-PASS).
From the 9th to the 11th, the company's share price rose for three straight sessions from the previous day. In particular, on the 11th, when the IR event for individual shareholders was held, it finished trading in the after-market (single-price session outside regular hours) at 289,500 won, up 10% from the regular-session close of 263,000 won. On the 12th, it spiked to as high as 300,000 won intraday.
◇ Flashy graphs of "mouse experiments" up front
During the overseas IR, Sam Chun Dang Pharm disclosed the status of its proof-of-concept (PoC) studies to validate the applicability of the S-PASS platform to antibody therapeutics.
The company presented a pharmacokinetic (PK) graph from mouse experiments indicating that the blood concentration of its Keytruda oral formulation using its technology appeared several times higher than that of a standard solution.
On the slide, the graph shows that the pembrolizumab solution, a standard liquid form of Keytruda's active ingredient, topped out at around 200 ng/ml after dosing, while SCD0513, which the company said applied S-PASS, exceeded 900 ng/ml just 0.5 hours after dosing.
The contrast looks stark if you see only the graph, but the problem is the data's substance. A small footnote at the bottom of the slide says, "Data and interpretation will be reflected after the lab readout, and currently this is a placeholder."
In effect, the core data are nothing more than a provisional, hypothetical graph presented as a placeholder.
The IR materials include phrases that can be read to suggest significant technical validation, such as having "demonstrated" the feasibility of making antibody therapeutics oral via other drugs (aflibercept, etanercept, etc.), achieved "proving" through scientific evidence, and "proven" platform scalability.
An industry source who reviewed the IR deck said, "They put a graph that doesn't reflect the actual final results up front, and some investors could mistake it for a formal research outcome," voicing concern.
◇ Sam Chun Dang Pharm says "proven" in IR, tells reporter it's at a "concept stage"
Sam Chun Dang Pharm told this outlet during reporting that the study is a concept study rather than a formal preclinical stage. Considering rumors spreading in the market and some wording used in the company's overseas IR materials, there is a disconnect.
Sam Chun Dang Pharm said, "In the industry, the common view is that antibody therapeutics cannot be made oral due to their large molecular size. Our slide is meant to show that, after applying our S-PASS technology and dosing animals, antibodies were detected in the blood." On why the key data were presented as a "placeholder," the company added, "Because the research is currently at the concept stage."
The company did not give a clear answer on whether it had discussions with MSD. A Sam Chun Dang Pharm official said, "There is an embargo from the other side not to open (disclose) this, so this is not at a stage to disclose now."
When asked whether "there is a partner other than MSD, the original developer, discussing development of an oral Keytruda formulation," a Sam Chun Dang Pharm official said, "We can't disclose it, but there is a partner." Asked next, "To develop for commercialization, don't you ultimately need a contract with MSD, which owns the original drug?" the official answered, "In most cases, it is highly likely to go that way."
◇ MSD officially denies: "No discussions with Sam Chun Dang Pharm"
MSD, the global drugmaker headquartered in the United States, officially denied as "groundless" market talk of "developing an oral Keytruda using Sam Chun Dang Pharm's S-PASS."
ChosunBiz sent the NDR materials disclosed by Sam Chun Dang Pharm to MSD to verify the facts behind the market rumors, and requested the global headquarters' review and internal confirmation results.
MSD said, "Based on checks through internal communication channels, there have been no discussions about partnerships, etc., with the company in question, Sam Chun Dang Pharm."
Industry sources noted that while the possibility of a formulation switch for an original drug can be explored at an early research stage, it is distinct from a commercialization stage.
Unlike developing a biosimilar using the same active ingredient, changing the formulation of an original drug makes the supply of materials and intellectual property (IP) issues key variables. In the drug approval process, disclosure of the active pharmaceutical ingredient supplier under the drug master file (DMF) system and proof of the manufacturing site are also required.
A representative of a company holding a bio platform technology said, "At the early research stage, independent work may be possible, but for actual technology transfer or product commercialization, consultations with the holder of the original drug are necessary."
Some in the market also mention the possibility that Sam Chun Dang Pharm could license out the technology by partnering not only through direct talks with MSD but also with third parties such as companies developing Keytruda biosimilars. However, industry observers say that in this scenario as well, the supply structure for raw materials, IP, and patent rights are intertwined in complex ways, posing significant practical constraints.
A patent expert said, "According to the U.S. FDA Orange Book, follow-on patents related to Keytruda (pembrolizumab) expire through the mid-to-late 2030s," adding, "Even if the formulation is changed, the original company's patent barriers on indications and dosing by cancer type remain in effect." The expert added, "If commercialization is pursued independently without prior consultations or contracts with MSD, there could be exposure to future dispute risks."
◇ A task even global big pharma hasn't cracked… substance needs verification
Experts say developing a high–molecular-weight antibody therapy like Keytruda into an oral drug is extremely difficult. Because antibodies are proteins, they are easily degraded by gastric acid and digestive enzymes, resulting in extremely low absorption when administered orally. As a result, there have been no cases to date of monoclonal antibody therapies approved and commercialized as oral drugs.
Most oral cancer drugs currently on the market are small-molecule targeted therapies with relatively low molecular weight, which differ technologically from antibody therapeutics.
In the end, observers say there is a large gap between Sam Chun Dang Pharm's research stage and market expectations. Verification of substance is needed, along with key data and clarity on the development path and partner rights.
A biotech industry expert said, "Developing an oral formulation of a large antibody therapy like Keytruda is a high-difficulty task that even global big pharma has not yet succeeded in commercializing," adding, "Confirming the absorption of some components in animal studies and developing a drug that can actually be administered to people are entirely different matters."
The expert advised, "Since Sam Chun Dang Pharm claims it has a separate partner, investors should take a cautious approach until the partnership structure and data are disclosed transparently."