Gan & Lee receives EMA orphan drug designation for Phase I drug candidate GLR2007 for the treatment of glioma
PR88861
BEIJING, and BRIDGEWATER, N.J., April 6, 2021 /PRNewswire=KYODO JBN/--
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee,
stock code: 603087.SH), a global biopharmaceutical company, today announced
that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products
granted orphan drug designation for the investigational compound GLR2007, for
the treatment of glioma.
Glioma is a broad term describing neuroepithelial tumors originating from glial
cells of the central nervous system, including astrocytic tumors such as
glioblastomas (GBM). GBM is one of the most aggressive primary brain tumors and
has median survival of 12 to 15 months, despite advances in surgery,
chemotherapy, and radiation therapy1. Gan & Lee's current clinical development
program for GLR2007, a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, is
investigating the treatment of advanced solid tumors which has the potential to
provide physicians and patients with a much-needed treatment option.
"The EMA's positive decision for GLR2007's orphan drug designation is another
milestone in the clinical development program as this compound was also
recently granted ODD by the FDA," Dr. Michelle Mazuranic, Head of Global
Medical Affairs, Gan & Lee. The granting of an orphan designation request does
not alter the standard regulatory requirements and process for obtaining market
approval.
Orphan drug designation in the European Union (EU) is granted by the European
Commission based on a positive opinion issued by the EMA Committee for Orphan
Medicinal Products. To qualify, an investigational medicine must be intended to
treat a seriously debilitating or life-threatening condition that affects fewer
than five in 10,000 people in the EU, and there must be sufficient non-clinical
or clinical data to suggest the investigational medicine may produce clinically
relevant outcomes and the potential for significant benefit over currently
approved products. The EMA orphan drug designation can provide companies with
clinical protocol assistance, differentiated evaluation procedures for Health
Technology Assessments in certain countries, access to a centralized marketing
authorization procedure valid in all EU member states, and reduced regulatory
fees. After being granted marketing approval, compounds with orphan designation
are eligible for 10 years of market exclusivity.
About Gan & Lee
Gan & Lee successfully developed the first Chinese domestic biosynthetic human
insulin. The company has five recombinant insulin analogs commercialized in
China including long-acting glargine injection (Basalin(R)), fast-acting lispro
injection (Prandilin(R)), fast-acting aspart injection (Rapilin[TM]), mixed
protamine zinc lispro injection (25R) (Prandilin(R)25), aspart 30 injection
(Rapilin[TM]30), reusable insulin injection pen (GanleePen[TM]), and disposable
pen needle (Ganlee Fine[TM]).
In the future, Gan & Lee strives to achieve a comprehensive coverage in the
field of diabetes diagnosis and treatment. Moving forward to advance Gan &
Lee's goal of becoming a world-class pharmaceutical company, we will also take
an active part in developing new chemical entities to treat various forms of
cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.
For more information, please contact investorrelations@ganlee.us.
References
1. Galanis E, et. al. https://doi.org/10.1200/JCO.2005.23.622
Contact: Gina Antonucci, #: 888-288-5395, investorrelations@ganlee.us
SOURCE: Gan & Lee Pharmaceuticals Co., Ltd.
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