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.

四川科伦博泰生物医药股份有限公司已获得中国国家药品监督管理局（NMPA）批准，可以对用于治疗实体瘤骨转移的放射性核素药物偶联物（RDC）SKB107进行临床试验。

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.

骨骼是癌症转移的常见部位，尤其是在晚期病例中。研究表明，70%至80%的晚期恶性肿瘤患者会发生骨转移。其中，前列腺癌、乳腺癌、甲状腺癌、肺癌和肾癌占此类病例的80%以上。

Bone metastases can cause severe complications, including intense pain, fractures, and spinal cord compression, significantly affecting patients' quality of life and increasing mortality risk.

骨转移可导致包括剧烈疼痛、骨折和脊髓压迫等严重并发症，显著影响患者的生活质量并增加死亡风险。

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.

当前的治疗选择包括止痛、放射治疗、骨骼修饰药物和手术。然而，这些方法在预防严重骨骼相关并发症、提高生活质量和延长生存期方面存在局限性。

The development of more effective and safer treatments remains a priority in oncology research.

开发更有效和更安全的治疗方法仍然是肿瘤学研究的重点。

The approval was granted following a review by the Center for Drug Evaluation.

该批准是在药品审评中心审查后授予的。

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.

SKB107，曾用名TBM-001，是科伦博泰首个进入临床试验的RDC药物。该药物由西南医科大学附属医院核医学科陈跃教授团队与科伦博泰合作开发。

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.

该药物使用小分子作为靶向配体，结合偶联技术、螯合剂和治疗性放射性核素，旨在通过提供靶向治疗以减少对健康组织的伤害，从而治疗实体瘤的骨转移。

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..

与治疗多处转移瘤方面具有局限性的外部放射疗法不同，SKB107有望对广泛的骨转移患者更有效。此外，与传统的骨改良药物相比，它有潜力破坏骨组织中的肿瘤细胞，提高治疗效果。

An exclusive licensing agreement for SKB107 was signed between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University on 14 September 2023.

2023年9月14日，科伦博泰与西南医科大学附属医院签署了SKB107的独家许可协议。

Source: prnewswire.com

来源：prnewswire.com