Gan Li Pharmaceutical CDK4/6 inhibitors are eligible for FDA orphan drug treatment of malignant glioma.

On September 10, Gan Li Pharmaceuticals announced that the FDA has granted its cell cycle protein-dependent kinase 4/6 (CDK4/6) inhibitor GLR2007 orphan drug eligibility for the treatment of malignant gliomas, including glioblastoma (GBM).
GLR2007 is an innovative small molecule chemical developed by Gan Li Pharmaceuticals.
-cycle protein-dependent kinase (CDK) is a key regulatory factor closely related to cell cycle regulation, while CDK4/6 is a key condition protein for the division and proliferation cycle of human cells.
CDK4/6 inhibitors can effectively block the activity of CDK4/6 kinases, restore cell cycle control, block tumor cell proliferation, and thus inhibit the growth of cancer cells.
GBM as a high-level glioma, the degree of malignancy is high.
The U.S. National Cancer Institute estimates that malignant gliomas affect two to three people per 100,000 people, accounting for 52% of all primary brain tumors and 17% of all brain tumors, including primary and metastomas.
the current clinical treatment of glioma for the main means of surgical removal combined with DNA methylation agent radiotherapy and drug chemotherapy, after surgery is very easy to relapse, the patient's five-year survival rate is still less than 5%.
global GBM drug market is expected to reach $1.4 billion by 2027, with a compound annual growth rate (CAGR) of 7.5%, according to GlobalData's 2018 forecast.
as of June 30, 2020, Gan Li Pharmaceuticals has invested 39.89 million yuan in research and development of GLR2007 three adaptive disorders.
In accordance with the Orphan Medicine Act of 1983 and the most recent amendments, gan li pharmaceutical industry in the research products by the FDA orphan drug qualification, the project's follow-up research and development, registration and commercialization will enjoy certain policy support, including: (1) market exclusive rights.
certified orphan drug is marketed with FDA approval for 7 years and is not subject to patents.
(2) tax credit.
50% of the cost of subsequent clinical trials for orphan drugs can be used as a tax credit and extended forward by 3 years and back by 15 years.
(3) exempt from the application fee for new drugs.
Ganli Pharmaceuticals GLR2007 project GBM adaptive drug eligibility, will be directly communicated with the U.S. FDA, on the follow-up project research and development and clinical trials, registration declaration and other communication and consultation with the U.S. FDA, and choose the best option to advance, so as to achieve the drug approval as soon as possible.
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