As FutureChem recently won approval for ProstaView, a domestically developed No. 43 new drug and a radiopharmaceutical (RPT) for diagnosing prostate cancer, expectations for technology exports are growing. With a theranostics strategy that links to a late-stage clinical radiotherapeutic for prostate cancer, the company appears to be accelerating efforts to penetrate the global market.
According to the pharmaceutical and biotech industry on the 22nd, FutureChem has launched a business linking ProstaView, a prostate-specific membrane antigen (PSMA)-based diagnostic agent recently approved by the Ministery of Food and Drug Safety, with the late-stage clinical prostate cancer treatment "Rudotadipep (FC705)."
The strategy is to pursue future global technology exports through "theranostics," an integrated diagnosis–treatment structure in which ProstaView first confirms a patient's PSMA expression and then proceeds to administration of FC705.
◇ Diagnose with "ProstaView," administer "FC705"… integrated diagnosis–treatment strategy
ProstaView injection is a diagnostic agent that combines the positron-emitting isotope "F-18" with a peptide targeting PSMA. After intravenous administration to a patient, positron emission tomography–computed tomography (PET-CT) can identify the location of cancer cells and whether there is metastasis at the molecular level. It is characterized by the ability to detect even micro-metastatic lesions that have been difficult to identify with existing imaging tests such as computed tomography (CT) and magnetic resonance imaging (MRI).
PSMA is a protein highly expressed in prostate cancer cells and is considered a key target in the global radiopharmaceuticals market. In particular, because radiotherapeutics can only be administered after first confirming PSMA expression, diagnostics and therapeutics effectively move as a set.
Switzerland's Novartis is also securing the market by operating the world's No. 1 prostate cancer radiotherapeutic "Pluvicto" together with the diagnostic agent "Locametz."
FutureChem likewise plans to use the ProstaView approval as a springboard to expand its business linked with the prostate cancer treatment "Rudotadipep (FC705)," which is in late-stage clinical trials. The strategy is to build an integrated diagnosis–treatment framework in which ProstaView first confirms a patient's PSMA expression and then proceeds to FC705 administration.
ProstaView is being credited with improving accuracy and sensitivity compared with existing imaging tests. In a domestic phase 3 trial, the primary endpoint, positive predictive value (PPV), was 86.96%. This is about 26.79 percentage points higher than the 60.16% PPV of prior imaging tests (CT, MRI, bone scan). The industry expects this to reduce the false-positive rate compared with existing imaging and enable more precise diagnosis.
Market interest is naturally extending to the therapeutic FC705. FC705 is currently in a domestic phase 3 trial and a U.S. phase 1/2a trial. In the domestic phase 3 trial, at least one administration to patients is expected to be completed within the year. It has been designated by the Ministery of Food and Drug Safety as an orphan drug and a global innovative product for expedited review, and a conditional approval process is also underway.
In the United States, after completing the last patient dosing for phase 2a on Sept. last year, data analysis is underway. The results are expected to be released in the fourth quarter of this year.
◇ "Efficacy higher than world's No. 1 RPT 'Pluvicto'"… potential Novartis technology export
In the market, Novartis is being cited as the most likely candidate for future technology exports.
FutureChem was in fact invited by Novartis earlier this year to attend the JPMorgan Healthcare Conference (JPM) in the United States, according to reports. JPM is an event where global big pharma corporations hold private meetings with companies that have promising technologies, and invitations are typically extended to companies that have undergone prior technical review.
The industry is also paying attention to the fact that global big pharma have recently been actively acquiring radiopharmaceutical corporations. Novartis acquired Endocyte, the original developer of Pluvicto, and U.S.-based Eli Lilly and Company also bought the radiopharmaceutical corporation Point Biopharma.
In particular, big pharma are known to view progression-free survival (PFS), the period during which the disease does not worsen and remains stable, as a key indicator in the technology adoption process. An industry official said, "In the radiotherapeutics field, whether PFS is secured at the interim data stage serves as a key variable in technology export negotiations."
Novartis is also moving to secure next-generation technology to cement its No. 1 position in the radiopharmaceuticals market. Beyond technology adoption, collaboration remains possible.
Amid this, market interest is focusing on the fact that FutureChem's FC705 shows differentiation from the competing drug Pluvicto in terms of tumor uptake speed and in vivo retention. For radiotherapeutics, treatment efficiency can vary depending on how quickly the agent reaches cancer cells and how long it remains within the tumor beyond a certain time.
In a prior phase 2 trial, when 100 mCi of FC705 was administered to 20 prostate cancer patients at 8-week intervals for up to six doses, the rate of a 50% or greater decrease in prostate-specific antigen (PSA) levels was 73.3%. The objective response rate (ORR), the proportion of patients whose tumors shrank, was 60%. The industry is focusing on the finding that meaningful efficacy was confirmed even at roughly half the dose compared with Pluvicto.
An official at an external specialized evaluation agency said, "If additional efficacy indicators such as progression-free survival (PFS) are secured in the upcoming phase 3 trial, the scale of technology exports with global big pharma, including Novartis, could grow to more than 1 trillion won."