Beijing, China/Bridgewater, New Jersey U.S, September 11, 2020 — 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 Orphan Drug Designation for GLR2007, for the treatment of malignant glioma. GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that Gan & Lee is developing for the treatment of advanced solid tumors. 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 therapy 1. “There is significant unmet medical need in this patient population, and this orphan drug designation represents an important milestone in the Gan & Lee clinical development program investigating GLR2007”, Michelle Mazuranic, Head of Medical Affairs, EU/US, Gan & Lee.
The FDA’s Orphan Drug Designation program grants orphan status to compounds intended to treat rare disorders that impact less than 200,000 people in the U.S annually 2. The designation provides certain benefits to the drug developer including 7 years of market exclusivity upon FDA approval, prescription drug user fee waiver and tax credits for qualified clinical trials 3. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining market approval. The Gan & Lee GLR2007 Phase 1 clinical trial (NCT04444427) is currently enrolling patients to establish the safety, tolerability, and optimal dosing strategy of GLR2007 in patients with advanced solid tumors. “Receiving Orphan Drug Designation for GLR2007 is a positive step forward in the development of this clinical program,” Kai Du, CEO of Gan & Lee Pharmaceuticals, Chairman of Gan & Lee USA Corporation.
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About Gan & Lee
Gan & Lee successfully developed the first Chinese domestic biosynthetic human insulin. At present, the company has four recombinant insulin analogs commercialized in China including long-acting glargine (Basalin®), fast-acting lispro (Prandilin®), mixed protamine zinc lispro injection (25R) (Prandilin®25) and fast-acting aspart, as well as prefilled injection pen (disposable) and insulin injection pen (reusable) commercialized in China.
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 disease, metabolic diseases, cancer, and other therapeutics.
1. Galanis, E., Buckner, J. C., Maurer, M. J., Kreisberg, J. I., Ballman, K., Boni, J., Peralba, J. M., Jenkins, R. B., Dakhil, S. R., Morton, R. F., Jaeckle, K. A., Scheithauer, B. W., Dancey, J., Hidalgo, M., Walsh, D. J., & North Central Cancer Treatment Group (2005). Phase II trial of temsirolimus (CCI-779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group Study. Journal of clinical oncology: officialjournal of the American Society of Clinical Oncology, 23(23), 5294–5304. http://doi.org/10.1200/JCO.2005.23.622
2. U. S. Food and Drug Administration.（2020, April 06 ）Designating an Orphan Product: Drugs and Biological Products [Press release]. Retrieved from
U. S. Food and Drug Administration. （2017, November 3）FDA at Rare Disease Day / February 28, 2011. [Pressrelease].Retrievedfrom