Date: 15-Sep-2020

US FDA Grants Orphan Drug Designation To Gan And Lees Malignant Glioma Drug GLR2007

Gan & Lee Pharmaceuticals Co., Ltd. (Gan & Lee), a global biopharmaceutical company, announced that the US 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.  “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 programme investigating GLR2007”, Michelle Mazuranic, Head of Medical Affairs, EU/US, Gan & Lee.

The FDA’s Orphan Drug Designation programme grants orphan status to compounds intended to treat rare disorders that impact less than 200,000 people in the US annually.  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. 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 programme,” Kai Du, CEO of Gan & Lee Pharmaceuticals, chairman of Gan & Lee USA Corporation.

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.