NMPA Approves Kelun-Biotech's SKB107 RDC for Treating Bone Metastases in Solid Tumors

CHENGDU, China, March 25, 2025 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced a significant milestone in its drug development efforts. The company has received approval from the Center for Drug Evaluation of the National Medical Products Administration to conduct clinical trials for its investigational new drug, SKB107. This development marks the company's first venture into the realm of radionuclide-drug conjugates (RDCs), with SKB107 set to explore innovative treatment avenues for bone metastases in solid tumors.

SKB107, originally known as TBM-001, represents a collaborative effort between Sichuan Kelun-Biotech and Professor Chen Yue's team at the Affiliated Hospital of Southwest Medical University. The drug leverages a small molecule as a targeting ligand, paired with advanced conjugation technology, an appropriate chelator, and a therapeutic radionuclide. The primary aim is to offer a treatment for patients suffering from bone metastases resulting from solid tumors.

This RDC drug holds promise for patients facing systemic multiple bone metastases. Its design ensures a high degree of targeting, minimizing damage to surrounding healthy tissues and potentially offering improved safety profiles compared to traditional external radiation therapy. Furthermore, SKB107 is expected to outperform conventional bone-modifying drugs by not only alleviating symptoms but effectively eradicating tumor cells with bone metastases, thereby enhancing its therapeutic potential.

The company forged an exclusive licensing agreement with the Affiliated Hospital of Southwest Medical University for SKB107 on September 14, 2023. This collaboration underscores the company's commitment to advancing novel treatment options for challenging medical conditions.

Bone metastasis is a prevalent concern in patients with advanced malignant tumors. Research indicates that approximately 70% to 80% of individuals with advanced tumors eventually develop bone metastases. Tumors such as prostate, breast, thyroid, lung, and kidney cancers are among those with the highest incidence of bone metastasis, collectively accounting for over 80% of such cases. The complications arising from bone metastasis, such as severe bone pain, pathological fractures, and spinal cord compression, can drastically affect patients' quality of life and increase mortality risks.

Current therapeutic strategies for bone metastases include a combination of pain management, radiation therapy, bone-modifying drugs, and surgical interventions. Despite these options, there remains an urgent need for treatments that can effectively enhance patients' quality of life, delay or prevent serious skeletal-related events, and extend survival times. Consequently, the development of drugs with novel mechanisms of action, combined with improved safety and efficacy profiles, is of paramount importance.

Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, concentrates on the research, development, manufacturing, and commercialization of innovative biological and small molecule drugs. The company targets major disease areas such as solid tumors, autoimmune diseases, inflammation, and metabolic disorders. It strives to build a global drug development and industrialization platform, addressing unmet medical needs in both China and internationally.

With a portfolio comprising over 30 key innovative drug initiatives, Kelun-Biotech has achieved significant progress, with three projects already available on the market, one in the New Drug Application stage, and more than ten others in various clinical stages. Additionally, the company's proprietary Antibody-Drug Conjugate platform, OptiDC™, has seen success with one ADC project approved for marketing and several others in the preclinical and clinical research phases.

The advancement of SKB107 into clinical trials signifies a pivotal development in the ongoing quest for innovative treatments for bone metastases, affirming Kelun-Biotech's dedication to pioneering new frontiers in the realm of biopharmaceuticals.