PR87848

BEIJING and BRIDGEWATER, N.J., Jan. 30, 2021 /PRNewswire=KYODO JBN/ --

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee)

(Shanghai: 603087.SH), a global biopharmaceutical company, today announced that

the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation

for GLR2007, for the treatment of patients with glioblastoma. GLR2007 is a

cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that Gan & Lee is developing

for the treatment of advanced solid tumors including glioblastoma, an

aggressive form of brain cancer with a low survival rate. Although considered a

rare disease, glioblastoma is the most common brain and central nervous system

(CNS) malignancy, accounting for 45.2% of malignant primary brain and CNS

tumors[1].

The one-year survival rate for glioblastoma is 39.3%. By year two and year five

post-diagnosis, the survival rate drops to 16.9% and 5.5%, respectively. The

average survival time for untreated patients is only three months[2]. Current

available treatments improve prognosis only by a matter of months. According to

Julius Huang, Director of Global Clinical Sciences, Gan & Lee, "The poor

prognosis and low survival rates for glioblastomas, demonstrate an unmet need

for new treatment options." The FDA's Fast Track Designation is designed to

facilitate the development and expedite the review of drugs to treat serious

conditions and fill an unmet medical need. Receiving Fast Track Designation

potentiates frequent meetings and written communication with the FDA. The

GLR2007 application is also eligible for Rolling Review and may be eligible for

Accelerated Approval, and Priority Review[3].

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)), mixed protamine zinc lispro injection (25R)

(Prandilin(R)25), fast-acting aspart injection, aspart 30 injection, and

insulin injection pen (reusable). For more information, please visit

https://ganlee.us.

References

1. Thakkar JP, et al. (2014). Epidemiologic and molecular prognostic review of

glioblastoma. Cancer Epidemiol Biomarkers Prev 23(10), 1-25.

2. Ostrom Q, et al. (2018). Chapter 2: Brain Metastases: Epidemiology. In

Schiff ED, Van den Bent MJ, Handbook of Clinical Neurology, Vol. 149 (3rd

series) Metastatic Disease of the Nervous System (pp. 27-42). Elsevier BV.

3. US Food and Drug Administration. (2018, January 04) Fast Track [Press

release]. Retrieved from

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

Contact:

Hollie Brissenden

+44 (0)560 364 0404

hollie@imcmedcom.com

Source: Gan & Lee Pharmaceuticals Co., Ltd.