FutureChem, which declared a shift from research and development (R&D)-centered corporations to the commercialization stage, received an administrative disposition from the Ministery of Food and Drug Safety for violating good clinical practice (GCP). With the domestic marketing authorization review for the prostate cancer diagnostic agent "FC303" underway, attention is on whether the timeline will be affected.
◇ Ministery of Food and Drug Safety issues first warning for GCP violation…clinical management capabilities on the line
The Ministery of Food and Drug Safety on the 20th said it issued a "warning" to FutureChem for violating the "obligation to comply with quality assurance for clinical trials and quality control of clinical trial data."
The legal grounds are Article 34(3)2 and (7) of the Pharmaceutical Affairs Act and Article 30(1) of the Rules on Safety of Drugs, etc. The core is the "accurate recording and storage of all clinical information," and the "establishment and implementation of standard operating procedures (SOPs)" to achieve this.
It is interpreted to mean that FutureChem failed to establish a system that ensures reliability at every stage where clinical data are generated.
An official at the Ministery of Food and Drug Safety said, "In the GCP inspection conducted to verify the reliability of the FC303 marketing authorization application data, no issues were identified that affect data reliability or participant safety," adding, "However, procedural violations such as in records were found, so we took administrative action."
The Ministery of Food and Drug Safety, as a rule, imposes administrative dispositions for "major" findings, while issuing corrective or supplementary measures for "significant" or "other" findings. The fact that FutureChem received an administrative disposition (warning) from the Ministery of Food and Drug Safety suggests that it received findings of "significant" or higher that could negatively affect the quality and integrity of trial results.
Administrative dispositions generally escalate in order from warning to business suspension to license revocation. If the same provision is violated again within one year, an aggravated disposition may be applied.
An official at the Ministery of Food and Drug Safety said, "Separately from the administrative disposition, we will take measures to prevent repeated violations by issuing corrective demands and requiring improvement plans from FutureChem," adding, "If the same item number or same subparagraph under the individual standards is violated again within one year after receiving an administrative disposition, we will impose a second administrative disposition, implementing aggravated measures according to the number of occurrences."
Industry observers say it cannot be ruled out that additional data submissions or requests for supplementation will follow during the authorization review process. There is also analysis that, for corporations pursuing global technology transfer or co-development, a history of GCP violations could be included in the due diligence items of overseas partners.
◇ A burden on the approval timeline…will it affect the clock on an earnings rebound
FutureChem plans to open the first year of its "transition to a commercialization corporation" by securing FC303 marketing authorization in the first half and launching within the year. Chief Executive Ji Dae-yun said in a recent letter to shareholders, "At launch, we will enter the market focusing on tertiary general hospitals and achieve annual sales of more than 10 billion won within two years."
FC303 is the starting point of the company's "theranostics (combined diagnosis and therapy)" strategy. The structure is to screen patients with the diagnostic and then move to the therapy "FC705."
FC705 is in phase 3 at eight hospitals in Korea with about 114 patients with metastatic castration-resistant prostate cancer (mCRPC). The goal is to finish next year and launch in 2029. The company said it is conducting U.S. trials in parallel and is pursuing global co-development or technology transfer.
If the FC303 approval timeline is delayed, the timing of improving the profit-and-loss structure could be pushed back, observers say. On a consolidation basis, the company's cumulative sales for the third quarter last year were 12.50893 billion won, up from a year earlier. However, the operating loss for the same period was 6.342 billion won, remaining in the red. The cumulative net loss attributable to owners of the parent was 3.68097 billion won.
The company's position is that this administrative disposition is not an issue that will affect the approval timeline. A FutureChem official said, "If there had been a serious problem, measures such as business suspension would have been taken."
At the beginning of the year, the Ministery of Food and Drug Safety expressed its commitment to strengthen post-management across clinical trials. In particular, it plans to expand inspections of sponsors and trial sites to verify the reliability of pivotal clinical trial result reports submitted with marketing authorization applications.
Amid a trend of more advanced oversight, how thoroughly FutureChem implements measures to reinforce its data management system is expected to be a key variable in the upcoming review process.