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.