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**188Re-NM-02** is a radiolabeled antibody-based therapeutic radiopharmaceutical designed for the treatment of HER2-positive cancers, particularly breast and gastric cancer. It consists of an anti-HER2 single domain antibody labeled with the beta-emitting radioisotope rhenium-188 (188Re). The drug targets the HER2 receptor (receptor protein tyrosine kinase erbB-2), delivering ionizing radiation directly to tumor cells that overexpress HER2, thereby inducing cytotoxicity through localized radiation damage. This approach enables targeted radionuclide therapy, aiming to minimize off-target effects while maximizing antitumor efficacy. The agent was initially developed by NanoMab Technology in collaboration with University Hospital Aachen and has been licensed to Radiopharm Theranostics for further development. Its primary indication is for patients with HER2-positive breast cancer who have experienced progression or recurrence after standard treatments such as surgery, chemotherapy, radiotherapy, or targeted therapy[1][3][5][7]. The drug is also referred to as a "theranostic" agent because its companion diagnostic version (99mTc-NM‑02) can be used for SPECT/CT imaging of HER2 expression in tumors[1][7]. Clinical trials are ongoing; no approvals have been reported as of April 2025.
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