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Beijing, China/Bridgewater, New Jersey U.S, April 6, 2021 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, today announced that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug designation for the investigational compound GLR2007, for the treatment of glioma.
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. Gan & Lee’s current clinical development program for GLR2007, a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, is investigating the treatment of advanced solid tumors which has the potential to provide physicians and patients with a much-needed treatment option.
“The EMA’s positive decision for GLR2007’s orphan drug designation is another milestone in the clinical development program as this compound was also recently granted ODD by the FDA”, Dr. Michelle Mazuranic, Head of Medical Affairs, EU/US, Gan & Lee. 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.
Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. To qualify, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes and the potential for significant benefit over currently approved products. EMA orphan drug designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, and reduced regulatory fees. After being granted marketing approval, products with orphan designation are eligible for 10 years of market exclusivity.
If you wish to learn more about GLR2007 clinical study information, please visit: https://clinicaltrials.gov/ct2/show/NCT04444427?term=glr2007&draw=2&rank=1
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), fast-acting aspart injection (Rapilin), mixed protamine zinc lispro injection (25R) (Prandilin25), aspart 30 injection (Rapilin30), reusable insulin injection pen (GanleePen), and disposable pen needle (Ganlee Fine).
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.
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: official journal of the American Society of Clinical Oncology, 23(23), 5294–5304. https://doi.org/10.1200/JCO.2005.23.622
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