Y-mAbs Announces NMPA Submission of BLA for DANYELZA® (naxitamab-gqgk) in China
Y-mAbs Therapeutics (NASDAQ: YMAB) announced that SciClone Pharmaceuticals has submitted a Biologics License Application (BLA) for DANYELZA® (naxitamab-gqgk) to China's National Medical Products Administration (NMPA) for treating relapsed/refractory high-risk neuroblastoma. This submission follows FDA approval within just seven months, indicating rapid progress in making the innovative therapy available to pediatric patients in China. Y-mAbs emphasizes the strategic collaboration with SciClone to ensure timely market entry if approved.
- BLA submission for DANYELZA® in China indicates rapid market expansion.
- Partnership with SciClone Pharmaceuticals to ensure quick availability of the treatment.
- DANYELZA® has already received FDA approval, establishing clinical credibility.
- None.
NEW YORK, July 06, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (“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 SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”) has submitted the Biologics License Application (“BLA”) for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the National Medical Products Administration (“NMPA”) of China.
Zhao Hong, the Chief Executive Officer and president of SciClone Pharmaceuticals, said: “Thanks to NMPA’s reform to accelerate the launch of global innovative drugs in China, we are excited that within just seven months after FDA’s approval of DANYELZA®, we have been able to submit our BLA to the NMPA in China. We are very pleased about the progress we are making and look forward to providing this innovative therapy to pediatric patients in China as quickly as possible.”
“We are pleased with the development capabilities of SciClone Pharmaceuticals resulting in accelerated timelines for submitting the DANYELZA® BLA in China. We believe this BLA submission marks another important milestone in our aim to make DANYELZA® globally available and address a clear unmet medical need for families in China. We look forward to working closely with SciClone Pharmaceuticals on the production and logistic planning of DANYELZA®, if approved by the NMPA, to make sure it will be in the market soon,” commented Thomas Gad, founder, Chairman and President at Y-mAbs.
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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
Forward-Looking Statements
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“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
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