SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative treatment for pediatric and adult patients.
Danyelza: Development and Designations
Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc. and fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs in December 2020 to co-develop and commercialize the drug in the Greater China region. The molecule has previously been awarded priority review status, breakthrough therapy designation, and orphan drug designation by the US FDA, highlighting its potential to address significant unmet medical needs.
Market Access and Commercialization
Danyelza was launched via Hainan’s Boao Lecheng special pilot zone early access channel in June 2021 and was also applied in the Tianjin free exchange pilot zone in December of the same year. In January 2022, the drug was commercialized in Taiwan via a special import policy. Most recently, in December 2022, a marketing approval was issued in China to treat children aged one year and over or adult patients with bone or bone marrow disease and recurrent or refractory high-risk neuroblastoma with partial remission, slight remission, or stable disease combined with other drugs.-Fineline Info & Tech
