[Edaily Reporter YU JIN-HEE ] #Cellbion Co., Ltd, a company specializing in radiopharmaceuticals (RPT), has cleared the final clinical hurdle for its next-generation prostate cancer drug, setting the stage for a quantum leap in its corporate value. With approval from the Ministry of Food and Drug Safety (MFDS) for a large-scale Phase 3 clinical trial in Korea, the company’s efforts to commercialize the new drug and secure global technology licensing (L/O) are expected to gain significant momentum.

Cellbion Co., Ltd announced on the 29th that it had received final approval from the Ministry of Food and Drug Safety (MFDS) for the Investigational New Drug (IND) application for its radiopharmaceutical candidate “177Lu-DGUL” (pocubotide satetrasetate, hereinafter “pocubotide”), which is intended for patients with metastatic castration-resistant prostate cancer (mCRPC). This achievement comes approximately three months after the company submitted its Phase 3 IND application to the MFDS last June. With this approval, the company will begin a multicenter confirmatory clinical trial centered on major hospitals in South Korea.

This Phase 3 clinical trial is the final confirmatory stage designed to systematically demonstrate the therapeutic efficacy and safety of Poqubotide in a broader patient population. The research team will recruit a total of 150 patients with mCRPC and divide them into an experimental group and a control group using a 1:1 randomization method. The treatment group will receive Forqubotide in combination with best supportive care and standard of care (BSC/SoC), while the control group will receive standard of care alone.

Cellbion Co., Ltd. plans to conduct a detailed comparative analysis of key efficacy endpoints, such as progression-free survival and overall survival, between the two groups to establish statistical significance. Poqubotide is an innovative therapy that precisely targets prostate-specific membrane antigen (PSMA), which is overexpressed on the surface of prostate cancer cells, to selectively strike cancer cells using the radioisotope lutetium-177 (¹⁷⁷Lu). It is expected to offer a new breakthrough in prolonging life for patients with advanced prostate cancer who have become resistant to existing standard treatments.

With this entry into Phase 3 trials, the roadmap for the early commercialization of Poqubotide monotherapy in Korea—which Cellbion Co., Ltd. is currently pursuing—is also gaining momentum. Cellbion Co., Ltd. is currently in the final stages of applying to the Ministry of Food and Drug Safety (MFDS) for conditional marketing authorization under the accelerated review process, based on Phase 2 clinical trial data. Given the nature of this severe disease with high unmet medical needs, if early approval is granted, it will become a strong contender to be “Korea’s 44th domestically developed new drug,” following in the footsteps of Curocell Inc.(372320)and FutureChem Co., Ltd.(220100).

The market’s focus on this clinical trial stems from its outstanding Phase 2 results, which outperform Novartis’ “Flubicto,” the world’s leading treatment for this condition.

According to data presented by Cellbion Co., Ltd. at the American Society of Clinical Oncology (ASCO 2026), the median radiological progression-free survival (mrPFS) in the pocubotide monotherapy group was 11.04 months, significantly outperforming Flubicto (8.7 months). The objective response rate (ORR) also reached 35.9%, demonstrating superior tumor shrinkage compared to Flubicto (29.8%).

The incidence of dry mouth—a major side effect of radiopharmaceuticals—was 13.2%, just one-third that of Flubicto (38.8%), demonstrating superior safety. Cellbion Co., Ltd is not resting on its laurels after confirming the efficacy of monotherapy but is accelerating collaboration with global big pharma companies to expand its indications.

The company has already successfully administered the first dose to a patient in a combination clinical trial with Merck (MSD)’s blockbuster immuno-oncology drug “Keytruda” (pembrolizumab). Conducted as a project supported by the Korea Drug Development Fund (KDDF), this clinical trial—despite being an early Phase 1 study—has proactively incorporated key Phase 3-level endpoints, such as overall survival (OS) and quality of life (QOL), to validate therapeutic synergy.

The company has also fully established the infrastructure for commercial-scale production. By establishing a one-stop center within the Korea Pasteur Institute in Pangyo, Gyeonggi Province—where processes range from candidate drug discovery to the production of finished products under Good Manufacturing Practice (GMP) standards—the company has completely eliminated the issue of half-life loss due to air transport. Leveraging its exceptional price competitiveness compared to imported drugs, which cost tens of millions of won per dose, the company aims to achieve sales in the tens of billions of won in South Korea alone in its first year of launch.

A Cellbion Co., Ltd official emphasized, “This Phase 3 IND approval marks a decisive turning point that clearly demonstrates the exceptional therapeutic value of Pocubotide to the market,” adding, “We will complete the large-scale confirmatory clinical trial without a hitch to provide prostate cancer patients with an innovative treatment option, and we will also swiftly bring to fruition discussions with global big pharma regarding technology exports valued in the trillions of won.”