In a significant stride for oncology innovation, China’s National Medical Products Administration (NMPA) has greenlit the investigational new drug (IND) application for SKB107, a cutting-edge radionuclide-drug conjugate (RDC). The approval, announced on March 25, 2025, sets the stage for clinical development of what could become a breakthrough treatment for patients suffering from bone metastases—one of the most debilitating complications of advanced solid tumors. Known in early stages as TBM-001, SKB107 represents a first-in-class therapy, combining a small molecule targeting ligand with conjugation technology, a chelator, and a therapeutic radionuclide to attack bone-based cancer spread with surgical precision. Its targeted mechanism is expected to limit damage to healthy tissue while aggressively eliminating cancerous cells embedded in the bone.

Unlike external radiation, which can’t effectively treat systemic bone metastases without inflicting collateral damage, or bone-modifying drugs that manage but rarely eradicate the problem, SKB107 is designed to target and destroy cancerous lesions in bone directly and comprehensively.

Bone metastases affect up to 80% of patients with advanced-stage malignancies, particularly those with prostate, breast, thyroid, lung, or kidney cancer. The condition can lead to intense pain, fractures, and spinal cord compression, severely impacting quality of life and hastening mortality. Existing treatments are limited, often palliative, and fail to significantly prolong survival or halt disease progression. In this bleak therapeutic landscape, SKB107 emerges as a beacon of hope. Its ability to selectively deliver radiation to cancer cells in the bone could represent a leap forward for a population in desperate need of better outcomes.

As SKB107 progresses through clinical evaluation, the oncology community will be watching closely. Whether it becomes a new standard in the treatment of bone metastases or paves the way for similar advancements in other cancer types, its journey represents a meaningful step toward a future where metastatic disease is not merely managed, but potentially overcome.