The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was 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.
Danyelza: Development and Launch
Danyelza was pre-emptively launched in Hainan’s Boao Lecheng special pilot zone in June 2021 and first prescribed in August that year to treat relapsed/refractory high-risk neuroblastoma. In addition, a Biologic License Application (BLA) filing for the drug was accepted for review by the National Medical Products Administration in July 2021. The drug was made available for reimbursement via the overseas special drug list in Beijing’s universal medical insurance supplementary scheme in October 2021. January 2022 saw the drug commercialized in Taiwan according to a local special import policy.
Clinical Development and Future Plans
An investigational new drug (IND) filing was made in China in April this year, designed to assess Danyelza in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) plus irinotecan and temozolomide in primary refractory or first recurrent high-risk neuroblastoma.-Fineline Info & Tech
