New Progress in Nuclear Medicine Imaging in China: 18F-Flotufolastat Injection Accepted for Marketing Review

By:DengYue International Business Division

In recent years, nuclear medicine imaging agents have played an increasingly important role in precision oncology diagnostics. According to publicly available information from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, on January 30, 2026, the new drug application for 18F-Flotufolastat injectionsubmitted by Beijing Sinotau International Pharmaceutical Co., Ltd. was officially accepted for review, with acceptance number CXHL2600134.

The product is a PSMA-targeted PET imaging agent designed for the detection of prostate cancer lesions. Its acceptance into the regulatory review process highlights the continued development of molecular imaging technologies in oncology.

International pharmaceutical supply and market-access observers, including DengYueMed, note that PSMA-targeted imaging agents are becoming an essential component of modern prostate cancer diagnostics as precision medicine continues to evolve globally.

Key Development Milestones in China

Public reports indicate that the drug recently reached several important milestones in China’s clinical development pathway.

● January 27, 2026 – The China Phase III clinical trial evaluating the diagnostic performance of flotufolastat F 18 reached its primary study endpoint.

● January 30, 2026 – The new drug application was accepted by CDE, entering the formal regulatory review stage.

The Phase III study was a multicenter clinical trial designed to evaluate the diagnostic accuracy and safety of the imaging agent in patients with biochemical recurrence of prostate cancer. Study results suggested that the imaging agent demonstrated favorable lesion detection capability in this patient population.

PSMA-Targeted PET Imaging for Prostate Cancer

Prostate cancer is one of the most common malignancies among men worldwide. With advances in molecular imaging, PSMA (Prostate-Specific Membrane Antigen)-targeted PET imaging has become an important tool for disease detection, staging, and recurrence evaluation.

The imaging mechanism of Flotufolastat F-18 Gallium-based tracers involves several key steps:

1.  The ligand selectively binds to PSMA proteins expressed on prostate cancer cells.

2.  The compound is labeled with the radioactive isotope Fluorine-18 (18F).

3.  After administration, PET/CT scanning enables visualization of tumor lesions and metastases.

Compared with conventional imaging methods, PSMA-PET often demonstrates higher sensitivity in detecting small metastatic lesions, helping physicians to:

● Identify primary tumors

● Detect early metastatic spread

● Localize sites of cancer recurrence

This capability can significantly improve treatment planning and clinical decision-making.

International Regulatory Status

Internationally, the radiopharmaceutical version of 18F-Flotufolastat has already received regulatory approval in the United States.

In May 2023, the U.S. Food and Drug Administration approved the PSMA-targeted PET imaging agent POSLUMA, which contains flotufolastat F 18 as its active component. The drug is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer.

Approved indications include:

● Patients with suspected metastatic prostate cancer

● Patients with rising PSA levels suggesting disease recurrence

Clinical studies supporting the approval included the SPOTLIGHT and LIGHTHOUSE trials, which demonstrated high specificity and diagnostic accuracy for detecting prostate cancer lesions.

Radiopharmaceuticals: A Rapidly Growing Oncology Field

Radiopharmaceuticals have emerged as one of the fastest-growing segments of the global pharmaceutical industry. These agents are generally categorized into two major groups:

Diagnostic radiopharmaceuticals

Used in PET or SPECT imaging to visualize disease processes.

Therapeutic radiopharmaceuticals

Used to deliver targeted radiation therapy to cancer cells.

PSMA-targeted technologies represent a particularly important area within this field, supporting the concept of “theranostics”—a model in which the same molecular target can be used for both diagnosis and therapy.

Industry Perspective

As global demand for precision oncology diagnostics continues to grow, molecular imaging technologies are expected to play an increasingly important role in cancer management.

Industry observers, including international pharmaceutical supply specialists at DengYueMed, believe that the regulatory progress of PSMA-targeted imaging agents reflects a broader trend: innovative nuclear medicine products are gradually entering multiple regulatory systems worldwide, improving access to advanced diagnostic tools.

With continued advances in radiopharmaceutical research and international collaboration, the development of agents such as Flotufolastat F-18 Gallium-based tracers may further expand the role of nuclear medicine in precision oncology.