Materials and tablets of cytarabine hydrochloride valine ester, a new chemical drug of Shenyang Pharmaceutical University, obtained clinical approval

Recently, the raw materials and tablets (acceptance No.: cxhl1502498, cxhl1502499 and cxhl1502500) of the new chemical drug cytarabine hydrochloride valine ester, developed by Shenyang Pharmaceutical University, have obtained the approval documents for clinical trials The product has been supported by national science and technology major special projects for major new drug creation, and now has two national invention patents (zl201210425599.4, zl200810083192.1) In 2010, the variety was transferred to Kunming Jida Pharmaceutical Co., Ltd and both parties reported to the State Food and Drug Administration for clinical research Cytarabine hydrochloride valine ester tablet was successfully developed by many research teams, such as Professor He Zhonggui's research group of Shenyang Pharmaceutical University The oral bioavailability of cytarabine hydrochloride valine tablets was increased from 21.8% to 60.0% compared with that of the mother drug cytarabine, which is completely suitable for oral administration, overcoming the limitation of the existing treatment of leukemia drugs, such as cytarabine, which can only be injected in clinic and can not be taken orally The tablet is the first in China, which greatly improves the adaptability of clinical patients, reduces the high medical costs of patients, and achieves good social and economic benefits after industrialization Next, clinical trials will be organized according to the requirements to further clarify the effectiveness and safety of the drug and promote the early listing of the drug