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Y-mAbs Announces Priority Review of BLA for DANYELZA (naxitamab-gqgk) in China

Nachrichtenquelle: globenewswire
13.09.2021, 15:00  |  722   |   |   

NEW YORK, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”), 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 its partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”) has been granted priority review of the Biologics License Application (“BLA”) for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”).

“We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China. Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022,” commented Thomas Gad, founder, Chairman and President at Y-mAbs.

Dr. Claus Moller, Chief Executive Officer, continued, “DANYELZA was recently prescribed for the first time in China, and we were excited to learn that the first patient had received treatment at the Lecheng Branch of Hainan Women and Children's Medical Center in Hainan Boao Lecheng International Medical Tourism Pilot Zone.”

Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) 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. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

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Y-mAbs Announces Priority Review of BLA for DANYELZA (naxitamab-gqgk) in China NEW YORK, Sept. 13, 2021 (GLOBE NEWSWIRE) - Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”), NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic …

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