Country for PR: United Kingdom
Contributor: PR Newswire Europe
Saturday, January 30 2021 - 02:10
Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA
BEIJING and BRIDGEWATER, N.J., Jan. 30, 2021 /PRNewswire-AsiaNet/ --

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 

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 


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

Hollie Brissenden 
+44 (0)560 364 0404

Source: Gan & Lee Pharmaceuticals Co., Ltd.