Shanghai Pharmaceuticals, a leading pharmaceutical company based in China (HKG: 2607, SHA: 601607), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, SPH4336. This designation is for the potential treatment of liposarcoma, a rare form of cancer.
SPH4336: A Promising Broad-Spectrum Anti-Tumor Agent
SPH4336 is an in-house developed oral inhibitor that has demonstrated broad-spectrum anti-tumor activities. It is currently undergoing a Phase II clinical study in the US for the treatment of patients with locally advanced or metastatic liposarcoma. Additionally, SPH4336 has concluded a Phase I study in China for advanced solid tumors. The molecule has shown a favorable efficacy, safety, and pharmacokinetics profile, positioning it as a promising candidate for further development.
Preparations for Phase Ib/IIa Study in China
Building on the positive data from previous studies, Shanghai Pharmaceuticals is preparing to initiate a Phase Ib/IIa study in liposarcoma in China. This next phase of clinical research will further evaluate the safety, tolerability, and efficacy of SPH4336, providing valuable insights into its potential as a treatment for liposarcoma patients.-Fineline Info & Tech
