On September 11, 2020 Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, reported that the U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation for GLR2007, for the treatment of malignant glioma (Press release, Gan and Lee Pharmaceuticals, SEP 11, 2020, View Source;lee-has-been-granted-orphan-drug-designation-by-the-us-fda-301128483.html [SID1234565045]). 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).

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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 therapy1. "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.