LNC PHARMA PTE. LTD. is delighted to announce that our significant novel radiopharmaceutical, ¹⁷⁷Lu-LNC1004 Injection, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) recently. This designation highlights the potential of ¹⁷⁷Lu-LNC1004 as a targeted treatment for patients with metastatic, radioiodine-refractory differentiated thyroid cancer who progress on or do not tolerate tyrosine kinase inhibitor therapy.

The Fast Track Designation (FTD) recognizes ¹⁷⁷Lu-LNC1004 as a therapy with potential to address an unmet medical need, underscoring LNC’s commitment to cutting-edge radiopharmaceutical solutions, grants us increased access to the FDA’s resources and support. This FTD enables us to streamline the development and review process. This will also facilitate a more rapid progression toward bringing ¹⁷⁷Lu-LNC1004 to the market, enhancing the treatment landscape for patients in need.

—— About ¹⁷⁷Lu - LNC1004 Injection ——

¹⁷⁷Lu-LNC1004 Injection specifically targets fibroblast activation protein (FAP), a widely expressed pan-tumor marker found in over 90% of tumor-associated fibroblasts derived from epithelial cells. This enables precise delivery of Lutetium-177 to FAP-positive tumors, facilitating high-precision radiopharmaceutical therapy.

—— A Significant Step Forward ——

This Fast Track Designation marks an exciting milestone for LNC, bringing us closer to our mission of developing transformative treatments. We remain committed to maintaining high regulatory standards throughout the remaining stages of clinical development and approval.