The company aims to revolutionize diabetes treatment with its innovative S-PASS platform and aims for results by year-end.
Category: World News
Samchundang Pharmaceutical has officially entered the global clinical trial phase for its oral insulin candidate, marking a significant milestone in diabetes treatment. On March 19, 2026, the company announced that it had submitted its Clinical Trial Application (CTA) for oral insulin under European clinical trial regulations (CTR).
The oral insulin candidate, identified as SCD0503, utilizes Samchundang's proprietary S-PASS platform, which employs innovative nano-emulsion and complex formation technologies. This breakthrough aims to prevent the degradation of insulin, enabling its absorption into the bloodstream when taken orally, a feat that has historically posed challenges for pharmaceutical companies.
According to a report by Korea Investment & Securities on March 20, the company is undergoing a transformative phase as it realizes significant milestones in the first quarter of 2026. The submission of the oral insulin clinical trial plan is described as the first tangible outcome of over a decade of research and development.
“Samchundang Pharmaceutical is showing a markedly changed profile, having achieved three major milestones this quarter alone,” said a researcher from Korea Investment & Securities. The firm anticipates that the clinical development period could be shortened, thanks to the extensive preparation that has already taken place, with results expected by the end of this year.
Samchundang's aggressive clinical design includes a head-to-head comparison with existing insulin injections, targeting Type 1 diabetes patients, who represent approximately 90% of global insulin consumption. This demographic is particularly crucial as they require insulin injections due to their bodies’ inability to produce the hormone naturally.
Following the trials for Type 1 diabetes, the company plans to immediately initiate additional clinical studies targeting Type 2 diabetes patients, who make up the majority of the diabetes population.
“This trial is not merely about developing an insulin product; it represents a historical turning point for our S-PASS platform to be recognized as a new standard in the global protein pharmaceutical market,” said a company representative. They emphasized the importance of securing strategic partnerships with global pharmaceutical firms to demonstrate the unique value of their platform.
The announcement has had a significant impact on the company's stock performance. On March 20, 2026, Samchundang's shares soared over 15%, propelling it to the top of the KOSDAQ market with a market capitalization exceeding 21 trillion won (approximately $18 billion). This surge came after the news of their clinical trial entry, pushing the share price to a record high of 92,000 won.
“The market reaction underscores the excitement surrounding the potential of oral insulin,” noted another analyst. The global insulin market is currently valued at around 40 trillion won (about $34 billion), predominantly driven by injectable formulations. If successful, Samchundang's oral insulin could be a game-changer, fundamentally altering the landscape of diabetes treatment.
The clinical trials will be conducted in collaboration with Profil, a specialized diabetes-focused contract research organization (CRO) based in Germany. The trials are set to evaluate the efficacy of oral insulin in controlling blood sugar levels, its bioavailability, and the impact of food intake, directly comparing it to subcutaneous insulin.
As the company prepares for the trials, it also plans to hold its regular shareholders meeting on March 30, 2026, and will conduct a non-deal roadshow (NDR) in Hong Kong and Singapore from April 20 to 23, targeting international investors. This event will provide updates on the global partnering status of the oral insulin and the development of additional pipelines including biosimilars and biobetters.
As the anticipation builds around the clinical trial results, investors are keenly watching the developments at Samchundang Pharmaceutical. The potential for oral insulin to succeed not only brings hope to patients but could also lead to a significant revaluation of the company’s market position and future prospects.
In summary, Samchundang Pharmaceutical's entry into the global clinical trials for oral insulin represents a significant leap forward in diabetes treatment, with the S-PASS platform at the forefront of this innovation. The results expected by the end of 2026 could redefine the treatment landscape and establish the company as a leader in the pharmaceutical industry.