Beijing, China/Bridgewater, New Jersey U.S., January 29, 2021 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 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 tumors¹.

The 1-year survival rate for glioblastoma is 39.3%. By year 2 and year 5 post-diagnosis, the survival rate drops to 16.9% and 5.5%, respectively. The average survival time for untreated patients is only 3 months². 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.  "The decision by the FDA to grant Fast Track Designation is important for the development of GLR2007", Lawrence Hill, CEO of Gan & Lee Pharmaceuticals USA, Chief Development Officer of Gan & Lee Pharmaceuticals.

About Gan & Lee

Gan & Lee successfully developed the first Chinese domestic biosynthetic human insulin.  At present, 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).

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.

References

1. Thakkar, J.P., Dolecel, T.A., Horbinski, C., Ostrom, Q.T., Lightner, D.D., Barnholtz-Sloan, J.S., and Villano, J.L. (2014). Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol Biomarkers Prev 23(10), 1-25.

2. Ostrom, Q., Wright, C., and Barnholt-Sloan, J. (2018). Chapter 2: Brain Metastases: Epidemiology. In E. D. Schiff and M.J. Van den Bent, Handbook of Clinical Neurology, Vol. 149 (3rd series) Metastatic Disease of the Nervous System (pp. 27-42). Elsevier B.V.

3. U. S. 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