[Edaily Reporter YU JIN-HEE ] #Cellbion Co., Ltd, a company specializing in radiopharmaceuticals (RPT), is expected to see its corporate value reassessed as it moves to commercialize a prostate cancer treatment and enhance the value of technology exports (L/O) from its pipeline. The company’s strategy is to accelerate its efforts, starting with the first patient dosing in a combination clinical trial with global big pharma Merck (MSD) for an immuno-oncology drug, followed by the approval of a domestically developed new drug in the second half of the year and discussions on technology transfers worth trillions of won.

First Patient Dosed in Merck’s ‘Keytruda’ Combination Trial... Phase 3-Level Endpoints Introduced

According to industry sources on the 29th, Cellbion Co., Ltd is conducting a combination clinical trial involving its radiopharmaceutical pipeline candidate “Lu-177-DGUL”(pocubotide satetrasetate, hereinafter “pocubotide”) in patients with metastatic castration-resistant prostate cancer (mCRPC) and Merck’s immunotherapy “Keytruda” (generic name pembrolizumab).

Selected as a new drug clinical development support project by the Korea Drug Development Fund (KDDF), this clinical trial will comprehensively evaluate the safety and efficacy of the combination therapy of the radiopharmaceutical and the immunotherapy in patients with metastatic castration-resistant prostate cancer. Pocubotide is a radiopharmaceutical therapy that targets prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells, and is a core pipeline product currently under development by Cellbion Co., Ltd.

The most notable feature of this trial is that, despite being an early-stage Phase 1 trial, its design and evaluation metrics have been elevated to Phase 3 levels. Typically, Phase 1 trials focus on verifying safety—including appropriate dosing and adverse effects—in a small number of participants. In contrast, following close coordination with Merck, Cellbion Co., Ltd has incorporated a wide range of in-depth efficacy endpoints, including △ overall survival (OS), △ objective response rate (ORR), △ prostate-specific antigen (PSA) response rate, and △ quality of life (QOL).

Specifically, OS will be used to closely monitor survival rates one year after treatment, while ORR will be used to calculate the rates of complete response (CR)—where cancer cells are completely eliminated—and partial response (PR)—where tumor size decreases—to verify the direct efficacy of the treatment. In addition to the PSA50 response rate—which assesses whether PSA levels have decreased by 50% or more compared to pre-treatment levels via blood tests—the company has introduced the “EORTC QLQ-C30” certified questionnaire to measure subjective improvements, such as reductions in pain and recovery of daily functioning.

By adopting an approach that allows immediate administration to eligible patients, the company plans to complete the patient enrollment schedule within this year and announce interim results in the first half of next year.

Demonstrating Superiority Over the World’s No. 1 ‘Flubicto’

In addition to expanding combination therapy options, Cellbion Co., Ltd. is proceeding smoothly through the final stages of commercializing forqubotide monotherapy in South Korea. Following the recent listing of Limkato Injection (No. 42) from Curocell Inc.(372320)and Prostavue Injection (No. 43) from #FutureCam as domestically developed new drugs, forcuvotide is being cited as a strong contender for “Domestically Developed New Drug No. 44.”

Cellbion Co., Ltd. has completed its application for conditional marketing authorization of Pocubotide in Korea with the Ministry of Food and Drug Safety and is currently engaged in final consultations for approval. For radiopharmaceuticals targeting severe diseases with high unmet medical needs, conditional approval is possible based solely on Phase 2 clinical trial results.

A key factor fueling market optimism is the superior data compared to Novartis’ “Flubicto,” which currently holds a monopoly in the global market. Cellbion Co., Ltd presented the final Phase 2 clinical trial data for Pocubotide at the “2026 American Society of Clinical Oncology (ASCO) Annual Meeting” held in Chicago, USA. Despite being administered as a monotherapy, it demonstrated a median overall survival (mOS) of 13.31 months and a median radiological progression-free survival (mrPFS) of 11.04 months.

Considering that Flubicto achieved only an mrPFS of 8.7 months even when combined with standard of care (SoC), Pocubotide’s ability to independently inhibit cancer progression is considered unparalleled. Pocubotide also outperformed Flubicto in overall response rate (ORR), recording 35.9% compared to Flubicto’s 29.8%. The incidence of dry mouth—a common side effect of radiopharmaceuticals—was only 13.2%, demonstrating superior safety compared to Flubicto (38.8%). According to data previously presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), the PSA50 response rate was 66.7%, indicating that approximately two out of every three patients showed a clear therapeutic response.

The production and supply infrastructure for commercialization has also been completed. Cellbion Co., Ltd has established an “Integrated R&D and GMP Center” within the Korea Pasteur Institute in Pangyo Techno Valley, Gyeonggi Province, and has begun preparations for commercial-scale production. By integrating the research laboratory (R&D Lab) and commercial manufacturing facilities (GMP) into a single space, the company has implemented a “Direct Scale-up” system that enables a seamless transition from candidate drug discovery to mass production without delays. It has also obtained approval from the Nuclear Safety and Security Commission and completed factory registration with local authorities.

Unlike imported finished products from overseas, which suffer radiation loss during air transport due to their short half-lives, Cellbion Co., Ltd. can supply drugs while maintaining optimal freshness through its own domestic production network. The company is also price-competitive. It plans to significantly improve patient access by setting prices below the cost of a single non-reimbursed dose of competing drugs (approximately 30–40 million won, with total treatment costs of about 200 million won). Based on this strategy, the company projects sales in the tens of billions of won in South Korea alone during the first year of launch.

Using domestic commercialization as a springboard, the company will also begin full-scale expansion into overseas markets. The company is currently engaged in negotiations with numerous global pharmaceutical companies, including those in China, exchanging proposals for partnerships and technology transfers. The industry estimates the technological value of Forqubotide to be over 1 trillion won.

A Cellbion Co., Ltd official emphasized, “The initiation of treatment for the first patient marks a significant step forward in expanding the clinical development scope of Forqubotide from monotherapy to combination therapy,” adding, “As this project is being carried out with support from the National New Drug Development Project, we will work closely with clinical institutions to ensure the trial proceeds smoothly.”

The official continued, “Establishing a one-stop hub within the Korea Pasteur Institute’s bio-ecosystem is a key step toward becoming a global company,” adding, “Based on validated data, we will secure major contracts with big pharma and evolve into a global pharmaceutical company with at least three new drugs by 2028.”