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The U.S. Food and Drug Administration (FDA) has granted GLR2007 a "fast track qualification" for the treatment of glioblastoma, the drug company announced.
GLR2007 is a cell cycle protein-dependent kinase 4/6 (CDK 4/6) inhibitor being developed by Ganli Pharmaceuticals for the treatment of advanced solid tumors, including glioblastoma.
although glioblastoma is considered a rare disease, it is the most common brain and central nervous system (CNS) malignancy, accounting for 45.2% of malignant primary brain and CNS tumors.
glioblastoma is an invasive brain cancer with low survival rates.
one-year survival rate was 39.3% in patients with glioblastoma.
the second and fifth years after diagnosis, the survival rate dropped to 16.9 per cent and 5.5 per cent, respectively.
survival time for untreated patients was only three months.
available treatment can only improve the prognosmation for a few months.
poor prognosis and low survival rates for glioblastoma suggest that the demand for new treatments is far from being met," said julius Huang, global clinical science director at Ganli Pharmaceuticals.
Pharmaceuticals has successfully developed China's first domestic biosynthetic human insulin.
owns five recombinant insulin similaries commercialized in China, including long-acting insulin glycerine injections (Basalin ®), quick-acting insulin injections (Prandilin®), fish protein lyphosphate zinc blends (25R®) (25R), quick-acting meldonium injections, aspart 30 injections and insulin injection pens (reusable).