Sichuan Kelun-Biotech Biopharmaceutical (Kelun-Biotech) has received approval in China to proceed with clinical trials for its investigational radionuclide-drug conjugate (RDC), SKB107.
The approval to SKB107’s new drug application (NDA) was granted by the National Medical Products Administration (NMPA)’s Center for Drug Evaluation.
It marks the first RDC drug clinical project undertaken by the company, which partnered with Professor Chen Yue’s team at the Affiliated Hospital of Southwest Medical University (SMU) for its development.
SKB107 employs a small molecule targeting ligand combined with conjugation technology, a chelator, and a therapeutic radionuclide. It is designed to target bone metastases in solid tumours.
According to Kelun-Biotech, SKB107 offers a more targeted approach than traditional external radiation therapies, reducing harm to healthy tissues. It potentially demonstrates improved safety and efficacy in treating bone metastases compared to conventional bone-modifying drugs.
In September 2023, Kelun-Biotech secured an exclusive licensing agreement with the Affiliated Hospital of SMU for this RDC drug candidate.
Earlier this month, Kelun-Biotech announced the NMPA approved its TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), for marketing in its second indication.
This approval pertains to the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). It applies to cases following progression on both EGFR-tyrosine kinase inhibitor therapy and platinum-based chemotherapy.
Kelun-Biotech operates as a subsidiary under Kelun Pharmaceutical, concentrating on research, development, manufacturing, commercialisation, and international partnerships in innovative biological and small molecule drugs.
The company is currently advancing over 30 drug projects. Of these, three have received marketing approval, one is in the NDA phase, and more than 10 are at various stages of clinical trials.
