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. 29, 2021 /PRNewswire/ -- 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®), fast-acting lispro injection (Prandilin®), mixed protamine zinc lispro injection (25R) (Prandilin®25), fast-acting aspart injection, aspart 30 injection, and insulin injection pen (reusable). For more information, please visit www.ganlee.us^[1].

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^[2].

Contact: Hollie Brissenden +44 (0)560 364 0404 hollie@imcmedcom.com^[3]

References

1. ^{^} www.ganlee.us (www.ganlee.us)
2. ^{^} https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (www.fda.gov)
3. ^{^} hollie@imcmedcom.com (www.prnasia.com)