
Samchundang Pharm has applied for global Phase 1/2 Investigational New Drug (IND) approval for SCD0503, an oral insulin new drug candidate developed in-house. Immediately after the announcement on March 20, the stock price surged by 18% in a single day, reaching an intraday market capitalization of 21.3698 trillion Korean Won, surpassing EcoPro to claim the top spot on KOSDAQ. Based on the closing price of 1,115,000 Korean Won, it has risen 379% this year alone. For the past 100 years, insulin has only been available as an injectable due to its easy degradation by stomach acid. Type 1 diabetes patients, who account for approximately 90% of global insulin consumption, are the initial target. If SCD0503 succeeds in clinical trials, it would disrupt the global insulin market itself ($40B, approximately 60 trillion Korean Won). European clinical trials are also being submitted concurrently, designed to confirm pharmacokinetic and pharmacodynamic equivalence with subcutaneous insulin under euglycemic clamp conditions. Clinical results are expected by the end of 2026. Korea Investment & Securities analyzed, "If successful, it would bring the world closer to developing the first oral insulin, potentially leading to technology exports worth tens of trillions of Korean Won." However, technical challenges remain in securing the absorption rate and stability of the oral formulation, making volatility difficult to avoid until data is released at year-end.

