[Edaily Reporter Yoo Jin-hee] Market attention is focused on whether #Cellion, regarded as a pioneer in the domestic radiopharmaceutical (RPT) market, will make history with a new domestically developed drug. Recently, #Curocell’s Limcato and #FutureCam’s Prostavue Injection were registered as the 42nd and 43rd domestically developed new drugs, respectively. Amid this trend, Selvion’s prostate cancer treatment, 177Lu-Pocuvotide (Pocuvotide), has emerged as a strong contender to become the 44th new drug in the second half of the year.

Drug

Anticipation for the launch of Korea’s 44th new drug in the second half of the year... Entering the final stage of commercialization

According to the biotech industry on the 11th, Selvion has completed its application for conditional marketing authorization for Pocuvotide in Korea with the Ministry of Food and Drug Safety (MFDS) and is accelerating final discussions and wrap-up work for approval. Radiopharmaceuticals targeting severe diseases with high unmet medical needs can receive conditional approval based solely on Phase 2 clinical trial results. Selvion expects final results to be available as early as the second half of this year.

Market attention is already focused on the explosive growth expected following approval. Celvion demonstrated its global competitiveness by presenting the final Phase 2 clinical trial data for Porqubotide at the 2026 American Society of Clinical Oncology (ASCO 2026) conference held in Chicago earlier this month. Despite being administered as a monotherapy, the drug delivered encouraging results, with a median overall survival (OS) of 13.31 months and a median radiological progression-free survival (rPFS) of 11.04 months.

The most notable aspect is the comparison data with Novartis’s Flubicto, which currently dominates the global market for radiopharmaceuticals for prostate cancer. Although Flubicto was used in combination with standard of care (SoC) treatment, its median rPFS was only 8.7 months. In contrast, Selvion’s Pocubotide recorded 11.04 months when administered as a monotherapy, thereby demonstrating its ability to inhibit cancer progression on its own.

The objective response rate (ORR), a key measure of treatment efficacy, was 35.9%, significantly outperforming Flubicto’s 29.8%. In particular, the incidence of dry mouth—a common side effect of radiopharmaceuticals—was only 13.2%, demonstrating superior safety compared to the competing drug (38.8%).

A biotech industry insider analyzed, “Although Selvion is a latecomer, the fact that it has demonstrated superior efficacy and safety compared to the world’s leading treatment makes it highly likely that its technological value will be reevaluated.”

Selvion has not only secured clinical data but has also fully established the infrastructure necessary for commercialization. Celvion recently completed preparations to begin operations at its integrated R&D and GMP center, established within the Korea Pasteur Institute in Pangyo Techno Valley, Gyeonggi Province. This facility combines a research laboratory (R&D Lab) and a commercial manufacturing facility (GMP), enabling “direct scale-up”—a seamless transition from candidate discovery to mass production without delays.

Given their short half-lives, freshness and supply stability are considered critical for radiopharmaceuticals. Finished products manufactured overseas, such as Flubicto, experience a loss of radioactivity during air transport. However, through its domestic direct production system, Cellion can supply patients with the freshest possible medication.

Collaboration with Merck and Technology Exports Worth Trillions... Global Expansion Comes into View

Its price competitiveness is also formidable. While a single non-reimbursed dose of competing drugs costs approximately 30–40 million won (with total treatment costs of about 200 million won), Cellion plans to price its product at around 27 million won, significantly lowering the financial barrier for patients. Selvion has established a strategy to generate sales in the hundreds of billions of won in South Korea alone in its first year of launch and rapidly secure market share.

Selvion’s sights are already set beyond the domestic market toward the global market. In collaboration with global pharmaceutical giant Merck (MSD), Selvion is accelerating efforts to expand indications by launching full-scale clinical trials in combination with the immuno-oncology drug Keytruda. Although formally classified as a Phase 1 trial, the company plans to elevate the trial design to a Phase 3 level to rigorously validate efficacy data, thereby increasing the value of a global technology export (L/O) deal.

The market already estimates the technological value of Pocubotide at over 1 trillion won. Selvion is currently in partnership negotiations with numerous global pharmaceutical companies, including those in China. Based on the data validated at ASCO 2026, there is a high likelihood of news regarding a major contract being announced within the year.

A Celvion official emphasized, “Establishing a one-stop hub within the optimal biotech ecosystem of the Korea Pasteur Institute is a crucial step toward our leap toward becoming a global company,” adding, “Starting with the commercialization of Pocubotide, we will evolve into a truly global pharmaceutical company with at least three new drugs by 2028.”