SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) has reached a significant milestone with the first prescription of Danyelza (naxitamab) in China, signifying its official commercial launch. Danyelza, a GD2-targeted monoclonal antibody, was originally developed by Y-mAbs Therapeutics Inc. and was fast-tracked for marketing approval in China in November 2020.
Licensing Agreement and Regional Development
In December 2020, SciClone entered into a licensing deal with Y-mAbs to co-develop and commercialize Danyelza in the Greater China region. This strategic partnership has facilitated the drug’s availability for patients in need within the region.
Pre-emptive Launch and Reimbursement Inclusion
Danyelza was pre-emptively launched in Hainan’s Boao Lecheng special pilot zone in June 2021, with the first prescription administered in August of that year to treat relapsed/refractory high-risk neuroblastoma. The drug’s Biologic License Application (BLA) was accepted for review by the National Medical Products Administration in July 2021. In October 2021, Danyelza was made available for reimbursement via the overseas special drug list in Beijing’s universal medical insurance supplementary scheme.
Commercialization and Regulatory Progress in Taiwan and Hong Kong
The drug was commercialized in Taiwan in January 2022 under a local special import policy. Danyelza received approval in China for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) plus irinotecan and temozolomide in primary refractory or first recurrent high-risk neuroblastoma in December 2022. The drug has also filed for approval in Hong Kong in February 2023, indicating ongoing efforts to expand access to this treatment across the region.-Fineline Info & Tech
