Jiluntai's independently developed HER2-targeted diagnostic new drug has been approved for clinical trials, expected to facilitate precision treatment of breast cancer

Jiluntai Company, a nuclear medicine innovation enterprise invested and incubated by Baiyang Pharmaceutical Group, has recently made important progress. Its independently developed Class 1 chemical radioactive diagnostic new drug——Technetium [⁹⁹ᵐTc] hydrazinonicotinamide dual-chain Ark peptide injection (⁹⁹ᵐTc‑HP‑Ark2), has received supplementary clinical trial application approval from the National Medical Products Administration (NMPA), which means the product will continue to undergo clinical trials, bringing new hope for precision subtyping and treatment of breast cancer.

This product is a radioactive diagnostic agent for SPECT/CT imaging, intended for the differential diagnosis of HER2-positive breast cancer. HER2 is an important prognostic indicator and therapeutic target for malignant tumors such as breast cancer, and this drug is expected to provide a non-invasive molecular imaging tool for precision subtyping, targeted therapy, as well as efficacy prediction and monitoring of breast cancer.

Currently, clinical assessment of HER2 expression status mainly relies on immunohistochemistry (IHC) testing of biopsy tissue, sometimes combined with fluorescence in situ hybridization (FISH) testing. Although this method has important value, it has limitations, such as being invasive, being affected by tumor heterogeneity, and being difficult to perform high-frequency dynamic monitoring. As a novel HER2-targeted SPECT/CT imaging agent, ⁹⁹ᵐTc‑HP‑Ark2 is expected to overcome these limitations.

By specifically binding to HER2 receptors on the surface of tumor cells, this drug can assess the HER2 expression status of patients in vivo. In addition, unlike the HER2 protein antigen epitope recognized by trastuzumab, this drug can be used to screen HER2-positive patients and provide information for dynamic monitoring of HER2 expression changes throughout the treatment course, providing guidance for individualized treatment.

Published prospective clinical research results show that ⁹⁹ᵐTc‑HP‑Ark2 SPECT/CT has good application prospects in screening potential beneficiaries of trastuzumab and monitoring efficacy during treatment. The preliminary results of this study are encouraging, showing high levels of diagnostic sensitivity, specificity, and accuracy.

In preclinical drug-resistant model studies, ⁹⁹ᵐTc‑HP‑Ark2 SPECT/CT was also able to non-invasively capture the upregulation of HER2 expression during trastuzumab resistance, as well as the downregulation of HER2 expression after PI3K inhibitor intervention. These findings have laid an important experimental foundation for subsequent whole-course efficacy monitoring and early identification of drug resistance.

It is worth mentioning that ⁹⁹ᵐTc‑HP‑Ark2 is the second product of Jiluntai Company in the field of SPECT/CT tumor imaging diagnosis. The company has successfully launched the integrin αvβ3-targeted imaging radiopharmaceutical ⁹⁹ᵐTc-3PRGD2, which is the world's first innovative drug targeting this target. In addition, the therapeutic radiopharmaceutical ¹⁷⁷Lu-AB-3PRGD2, also targeting integrin αvβ3, has also obtained clinical trial approval, marking Jiluntai's rapid development in the field of radiopharmaceutical R&D and its ongoing construction of a "theranostics" platform from diagnosis to treatment.

The successful development of ⁹⁹ᵐTc‑HP‑Ark2 is expected to open a broader "theranostics" pathway, guiding diverse clinical decisions such as existing targeted therapy, immunotherapy, and cell therapy through nuclear medicine molecular imaging, enhancing the precision and effectiveness of tumor treatment, and opening up broader space for precision diagnosis and treatment of tumors.