YMAB - Y-mAbs' Danyelza for neuroblastoma gets approval in China

• China's National Medical Products Administration granted conditional approval to Y-mAbs Therapeutics' ( NASDAQ: YMAB ) Danyelza to treat neuroblastoma.
• Neuroblastoma is a cancer which develops from immature nerve cells found in several parts of the body.
• Danyelza was conditionally approved, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), to treat patients 1 year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have shown a partial or minor response, or stable disease to prior therapy.
• Y-mAbs said continued approval for this indication may be based on verification of clinical benefits in a confirmatory trial Study 201, where not less than 10 patients shall be enrolled in China.
• Danyelza (naxitamab-gqgk) 40mg/10ml will be marketed in China by Y-mAbs' partner SciClone Pharmaceuticals, according to the company.

For further details see: