China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving an Orphan Drug Designation (ODD) from the US FDA for its Category 1 drug candidate KH617 in glioblastoma. This designation is a significant milestone in the development of KH617, which is aimed at treating advanced solid tumors and recurrent glioblastoma.
KH617: Development and Indications
KH617 is an innovative preparation developed using high-purity raw materials produced by traditional Chinese medicine active pharmaceutical ingredient engineered bacteria. The drug is currently under development to treat advanced solid tumors and recurrent glioblastoma, a particularly aggressive form of brain cancer. The Orphan Drug Designation from the US FDA will help accelerate the development and commercialization of KH617, providing patients with a potentially new treatment option.
Clinical Trial Progress
A clinical trial filing for KH617 was accepted for review by the Center for Drug Evaluation (CDE) in July last year. This acceptance marks a crucial step in the regulatory process, bringing KH617 one step closer to clinical trials and potential market approval. The development of KH617 is expected to contribute significantly to the treatment landscape for glioblastoma and other advanced solid tumors.-Fineline Info & Tech
