Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China
December 08 2022 - 9:00AM
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.
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 cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA®
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate at the registration-stage, OMBLASTYS®
(omburtamab), which targets tumors that express B7-H3.
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inflation and uncertain global credit and capital markets; and
other risks and uncertainties affecting the Company including those
described in the "Risk Factors" section included in our Annual
Report on Form 10-K for the year ended December 31, 2021, our
Quarterly Reports on Form 10-Q for the quarters ending March 31,
2022, June 30, 2022, September 30, 2022 and in our other SEC
filings. Any forward-looking statements contained in this press
release speak only as of the date hereof, and the Company
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered
trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350New York,
NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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