NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the National Medical Products Administration (“NMPA”) in China has granted DANYELZA (naxitamab-gqgk) 40mg/10ml conditional approval. DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).
DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks.
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial, Study 201, where no less than 10 patients shall be enrolled in China.
“Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in China. It’s very exciting to see this treatment conditionally approved in such a substantial territory after a solid joint effort by our Chinese partner SciClone Pharmaceuticals and the development team at Y-mAbs,” said Thomas Gad, founder, President and Interim CEO.
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.