Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received ethical approval from Beijing Hospital to conduct a Phase III clinical study. The study will assess the diagnostic efficacy of a radionuclide candidate, intended for use with positron emission tomography (PET) imaging, in detecting pelvic lymph node metastases in patients undergoing radical surgery for prostate cancer. The drug is also expected to support the diagnostic efficacy and safety of PET/CT imaging in patients with biochemical recurrence of prostate cancer.
The Category 1 chemical drug, a radionuclide targeting PSMA, is not yet commercially available anywhere and is suitable for prostate cancer patients who are about to receive initial radical treatment and are suspected of having metastases, as well as those with elevated serum prostate-specific antigen (PSA) levels who are suspected of biochemical recurrence.
While no similar product has been approved in China, Lantheus’s 18F-PSMA diagnostic drug PYLARIFY is commercially available internationally, generating USD 620 million in sales during the first three quarters of 2023.- Flcube.com
