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Ganli Pharmaceutical's research product GLR2007 was recognized as an orphan drug by the European Commission

 On April 6, Ganli Pharmaceutical issued an announcement stating that it had recently received an official written reply from the European Commission ("EC"), granting the company's innovative drug cyclin-dependent kinase 4/6 (CDK4/6) inhibition (Hereinafter referred to as "GLR2007") orphan drug qualification for the treatment of glioma.

GLR2007 is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. It is an innovative small molecule chemical drug independently researched and developed by the company. It is intended to be used for various advanced solid tumors including glioma treatment. The drug has started a phase I clinical trial in the United States in July 2020 and obtained FDA orphan drug designation in September 2020 for the treatment of malignant gliomas including glioblastoma (GBM). In November 2020, the clinical trial application in the State Drug Administration of China was accepted. In January 2021, it was granted fast-track qualification by the FDA.


This time, Ganli Pharmaceutical's innovative drug GLR2007 was successfully approved by the European Commission (EC) as an orphan drug for the treatment of glioma. Glioma is a broad term describing neuroepithelial tumors derived from glial cells of the central nervous system, including astrocytomas such as glioblastoma (GBM). GBM is one of the most aggressive primary brain tumors. The current clinical treatment methods are mainly surgical resection combined with DNA methylation agent radiotherapy and drug chemotherapy. It is very easy to relapse after surgery, and the five-year survival rate of patients is still insufficient. 5%. According to the forecast released by GlobalData in 2018, the global GBM drug market is expected to reach 1.4 billion US dollars by 2027, with a compound annual growth rate (CAGR) of 7.5%.


As of September 30, 2020, the GLR2007 project has invested a total of 57.3 million yuan in R&D.

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