Y-mAbs Signs License Agreement with SciClone for DANYELZA® (naxitamab-gqgk) and Omburtamab in China

IndustryPRwire -- Y-mAbs Therapeutics announced that it has entered into a license agreement with SciClone Pharmaceuticals International Ltd (“SciClone”) to be the exclusive co-development and commercialization partner of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in China. DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration (“FDA”) on November 25, 2020 and 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. The Company plans to resubmit its Biologics License Application (“BLA”) to the FDA for omburtamab by the end of 2020 or in early 2021.

The license agreement includes Greater China, including Mainland China, Taiwan, Hong Kong and Macau. Under the terms of the agreement, SciClone will employ its development, sales, marketing and regulatory expertise to commercialize DANYELZA and omburtamab, if approved, in the territory. All other unpartnered geographies worldwide remain with the Company. Under the terms of the agreement, SciClone will pay Y-mAbs a $20 million upfront payment with the potential for Y-mAbs to receive up to $100 million in additional development, regulatory and sales milestone payments for both programs, as well as double-digit royalties on net sales for DANYELZA and omburtamab in the territory.

“We are very pleased to enter this license agreement with SciClone, and hope to see a DANYELZA and omburtamab, if approved, being made available to appropriate children with unmet medical needs in China. This partnership marks an important milestone in our aim to make our lead product and product candidate globally available,” said Thomas Gad, founder, Chairman and President at Y-mAbs.

“DANYELZA and omburtamab were initially identified and sourced from Memorial Sloan Kettering Cancer Center in New York, and have been developed by Y-mAbs as novel therapies. We believe these antibodies show great promise,” said Hong Zhao, President and Chief Executive Officer of SciClone. “We are excited to partner with Y-mAbs team to commercialize DANYELZA for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, if approved. This strategic partnership recognizes SciClone’s capability as a leading biotech company with integrated platform of development and commercialization.”

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

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