Selbion is showing strong performance. Recently, news that the company received results from an independent imaging evaluation committee for a Phase 2 clinical trial assessing the safety, tolerability, radiation dose, and anticancer effects of a new radiopharmaceutical drug (Ga-68-NGUL / Lu-177-DGUL) in patients with metastatic castration-resistant prostate cancer appears to be influencing its stock price.
As of 9:22 AM on the 5th, Selbion is trading at 15,730 KRW, up 12.13% from the previous day.
The previous day, a media outlet reported that the objective response rate (ORR) among 61 patients was 47.5%. This significantly surpasses the ORR of 29.8% reported in the Phase 3 clinical trial of Pluvicto, a radiopharmaceutical prostate cancer treatment approved by the U.S. Food and Drug Administration (FDA) in March 2022, which involved 319 patients. ORR refers to the proportion of patients who show an objective treatment response, such as tumor size reduction, among the total patient population. Pluvicto's sales last year reached 980 million USD (approximately 1.4 trillion KRW).
Kim Kwon, CEO of Selbion, explained, "The figures are more encouraging than the previous interim results," adding, "We will review the final clinical data from 73 patients."
He further noted, "Although Pluvicto's trial involved 319 patients, it is significant that we are conducting clinical trials with over 70 terminal cancer patients domestically."
Looking at the specific data, among 61 patients, 29 showed complete response (CR) or partial response (PR), resulting in an ORR of 47.54%. Among 59 patients with available PET/CT imaging, 46 showed complete metabolic response (CMR) or partial metabolic response (PMR), leading to a total metabolic response rate of 77.97%.
Selbion plans to complete the clinical trial by the first quarter of next year and launch the product around October. The non-reimbursed supply price of Lu-177-DGUL is expected to be set at approximately 27 million KRW.
Based on the efficacy and safety data from Phase 2, Selbion anticipates entering into active licensing-out (LO) discussions with multiple global pharmaceutical and biotech companies. Given that Pluvicto became a blockbuster drug within two years of its launch, it is expected that licensing deals worth trillions of KRW could be possible.
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