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Blue Earth Diagnostics, Sinotau Pharmaceutical Group Partner to Bring Posluma to China

This story has been updated to clarify that Blue Earth Diagnostics will provide regulatory and technology support to Sinotau Pharmaceuticals. 

NEW YORK – Bracco Imaging subsidiary Blue Earth Diagnostics said on Tuesday that it has partnered with Sinotau Pharmaceutical Group to bring Posluma (flotufolastat F 18) to China.

Through the strategic partnership, Blue Earth will provide Beijing-based Sinotau with regulatory and technology support to make the PET imaging agent available in the country for identifying prostate-specific membrane antigen (PSMA)-positive tumors in prostate cancer patients.

According to a statement from Oxford, UK-based Blue Earth, the partnership is part of a larger plan to expand global access to Posluma. The agent, which was formerly called 18F-rhPSMA-7.3, is used to help guide treatment decisions for patients with prostate cancer and to assess patients' recurrence after surgery, radiotherapy, and systemic treatment.

The Chinese Society of Clinical Oncology recommends using PSMA-PET to evaluate patients' treatment responses and longer term follow-up. There are no fluorine-18-labeled PSMA-PET radiopharmaceuticals available in China, however, and Blue Earth and Sinotau want to fill that gap with Posluma.

In the US, the Centers for Medicare & Medicaid Services (CMS) recently granted transitional pass-through payment status to Posluma for detecting PSMA-positive prostate cancer metastases.

"Flotufolastat F 18 represents a new class of PSMA-targeted PET radiopharmaceuticals that are based on novel radio-hybrid technology," Blue Earth CEO David Gauden said in a statement. "It is engineered to advance clinical decision-making by providing useful information to guide treatment planning in men with prostate cancer [and] we believe that [its] demonstrated diagnostic performance, with its high-affinity PSMA binding and low urinary bladder activity, makes it a valuable diagnostic tool for markets around the world."

Meanwhile, Blue Earth Diagnostics' sister company Blue Earth Therapeutics is developing a lutetium-labeled radiopharmaceutical with a similar structure to Posluma as a potential treatment for PSMA-positive prostate cancer.