[Market Focus] Selbion Surges as Merck's Sole Radiopharmaceutical Partner for Keytruda; Phase 2 Results Imminent

Selbion shares are surging. The rally is attributed to news that the announcement of the phase 2 clinical trial results for its main pipeline drug, Lu-Pocuvotide, for metastatic castration-resistant prostate cancer (mCRPC), is imminent.

As of 1:37 p.m. on July 3, Selbion was trading at 24,300 won, up 9.21% from the previous day.

According to industry sources, Merck signed a joint research agreement with Selbion in February to conduct commercial clinical trials. On June 23, Selbion submitted an IND application to the Ministry of Food and Drug Safety for a phase 1 clinical trial of a combination therapy using Keytruda and Lu-Pocuvotide for mCRPC. Analysts note that if significant results are obtained in phase 1, the likelihood of technology transfer to Merck appears high.

Oh Byungyong, a researcher at Hanyang Securities, predicted that Lu-Pocuvotide could obtain marketing approval in the first half of next year. In the interim results of the phase 2 trial announced in December 2024, Lu-Pocuvotide achieved an objective response rate (ORR) of 47.5%. This significantly exceeded the 29.8% ORR reported in the phase 3 clinical trial (VISION study) of Novartis's new drug Pluvicto.

Researcher Oh stated, "Selbion plans to apply for conditional approval to the Ministry of Food and Drug Safety as soon as it secures the final results in the fourth quarter, and expects marketing approval in the first half of next year." He added, "'Lu-Pocuvotide' has been designated as the 11th product under the MFDS Global Innovative Product Fast Track (GIFT) program, so an expedited review is anticipated."

He also assessed that the market potential is sufficient. Assuming the price per dose of Lu-Pocuvotide is 27 million won and patients receive five doses per year, Selbion's annual sales could exceed 40 billion won if the number of treated patients surpasses 300.