Kelun-Biotech’s Radionuclide-Drug Conjugate SKB107 Receives Approval for Bone Metastases Treatment
Wednesday, March 26, 2025
Sichuan Kelun-Biotech Biopharmaceutical has received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials for SKB107, a radionuclide-drug conjugate (RDC) developed for treating bone metastases in solid tumors.
Bone is a common site for cancer metastasis, particularly in advanced cases. Studies indicate that between 70% and 80% of patients with advanced malignant tumors will develop bone metastases. Prostate, breast, thyroid, lung, and kidney cancers account for over 80% of such cases.
Bone metastases can cause severe complications, including intense pain, fractures, and spinal cord compression, significantly affecting patients' quality of life and increasing mortality risk.
Current treatment options include pain relief, radiation therapy, bone-modifying drugs, and surgery. However, these methods have limitations in preventing severe bone-related complications, improving quality of life, and extending survival.
The development of more effective and safer treatments remains a priority in oncology research.
The approval was granted following a review by the Center for Drug Evaluation.
SKB107, previously known as TBM-001, is Kelun-Biotech’s first RDC drug to enter clinical trials. It has been developed in collaboration with the Affiliated Hospital of Southwest Medical University, led by Professor Chen Yue’s team.
The drug uses a small molecule as a targeting ligand, along with conjugation technology, a chelator, and a therapeutic radionuclide. It is designed to treat bone metastases in solid tumors by offering targeted therapy with reduced harm to healthy tissues.
Unlike external radiation therapy, which has limitations in treating multiple metastases, SKB107 is expected to be more effective for patients with widespread bone metastases. Additionally, in comparison to conventional bone-modifying drugs, it has the potential to destroy tumor cells in bone tissue, improving treatment outcomes.
An exclusive licensing agreement for SKB107 was signed between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University on 14 September 2023.
Source: prnewswire.com
