[Click e-Stock] "Selbion, the Only Radiopharmaceutical Partner for Merck's Keytruda"

On July 2, Hanyang Securities analyzed that Selbion is the only radiopharmaceutical (RPT) partner for Merck's Keytruda and that there is significant potential for the global expansion of 'Lu-Pocuvotide' through combination therapy with Keytruda. The company did not provide an investment opinion or a target price.

Oh Byungyong, a researcher at Hanyang Securities, stated, "In February, Merck signed a joint research agreement with Selbion to conduct commercial clinical trials," and added, "On June 23, Selbion submitted an IND application to the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of Lu-Pocuvotide, a treatment for metastatic castration-resistant prostate cancer (mCRPC), in combination with Keytruda." He continued, "If meaningful results are obtained in Phase 1, the likelihood of technology transfer to Merck also appears high."

Oh predicted that Lu-Pocuvotide could receive product approval in the first half of next year. In the interim results of the Phase 2 clinical trial announced in December last year, Lu-Pocuvotide recorded an objective response rate (ORR) of 47.5%. This far exceeded the 29.8% result from Novartis's new drug Pluvicto in the Phase 3 VISION study.

He explained, "Selbion plans to apply for conditional approval to the MFDS as soon as the final results are secured in the fourth quarter and expects product 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 expected."

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

He emphasized, "The domestic mCRPC patient population is estimated to be around 4,000 to 5,000." He continued, "For reference, the non-reimbursed price of Pluvicto exceeds 30 million won per dose, and discussions are currently underway regarding reimbursement." He added, "If Pluvicto becomes reimbursed, the relatively lower-priced Lu-Pocuvotide is also likely to be covered by insurance, which would be a positive factor for Selbion."