Cellbion announced on the 30th that it has submitted an application to the Ministry of Food and Drug Safety for a domestic Phase 3 clinical trial plan (IND) to evaluate the efficacy and safety of the radiopharmaceutical 'Lutetium (177Lu) DGUL (phocubotide satetraxetan)' in patients with metastatic castration-resistant prostate cancer (mCRPC).

Clinical Trial Design and Methodology This trial is a multi-center, open-label, randomized Phase 3 study to be conducted at multiple domestic institutions, including Seoul National University Hospital. A total of 150 patients with metastatic castration-resistant prostate cancer will be assigned to the treatment and control groups at a 1:1 ratio to compare the efficacy and safety of Lutetium (177Lu) DGUL combination therapy versus Best Supportive Care/Standard of Care (BSC/SoC) alone.

The company has set radiographic progression-free survival (rPFS) as the primary endpoint of this trial, with efficacy and safety as secondary endpoints. The treatment group will receive Lutetium (177Lu) DGUL a total of four times at six-week intervals, with the possibility of up to six administrations if predefined criteria are met. Additionally, if radiographic disease progression is confirmed in the control group, the trial is designed to allow a cross-over to the Lutetium (177Lu) DGUL combination therapy following a separate consent procedure. The trial period is scheduled for approximately 36 months from the date of Institutional Review Board (IRB) approval and may vary depending on subject enrollment status.

Future Schedule and Investment Considerations Cellbion stated that this disclosure pertains to the completion of the clinical trial plan approval application submitted to the Ministry of Food and Drug Safety. If the clinical trial plan receives final approval in the future, the company plans to immediately disclose the relevant information.

Furthermore, through investment considerations, the company noted that the statistical probability of a clinical trial drug receiving final pharmaceutical approval is known to be approximately 10%. As there is a possibility that clinical trials and the product approval process may yield results that fall short of expectations, leading to changes in or discontinuation of commercialization plans, the company urged investors to carefully consider the investment risks disclosed in periodic disclosures and business reports and to invest prudently.