??? ? ???? ?????, 2021? 1? 31? PRNewswire=???? 31?, ???? ???? ?? Gan & Lee Pharmaceuticals Co., Ltd.(?? Gan & Lee)(???: 603087.SH)? GLR2007? ?? ????? ?? ????? ?? ?????(FDA)???? ???? ??(Fast Track Designation)? ???? ????. GLR2007? ?????? ??? ??? ?? ?? ????? Gan & Lee? ?? ?? ???? ??? ????(cyclin-dependent kinase 4/6, CDK 4/6) ????. ?????? ???? ?? ???? ????. ?????? ?????? ???, ?? ?? ? ? ?? ???(central nervous system, CNS) ?? ?????, ?? ??? ?? CNS ?? ? 45.2%? ????[1].
?????? 1? ???? 39.3%?. ?? ???? 2?? 5? ???? ???? ?? 16.9%? 5.5%? ????. ??? ?? ?? ??? ?? ?? ??? 3??? ????[2]. ?? ?? ??? ???? ? ?? ???? ??? ??? ???. Gan & Lee ??? ?? ??(Global Clinical Sciences) ?? ??? Julius Huang? "?????? ??? ?? ?? ???? ?? ?? ??? ???? ?? ???? ?? ??? ??? ?"??? ????. FDA? ??? ????, ???? ?? ??? ??? ????? ?? ??? ????, ?? ??? ??? ???? '???? ??(Fast Track Designation)' ??? ????. ???? ??? ???, FDA? ?? ????, ??? ??? ? ??. GLR2007? ?? ??(Rolling Review)? ?? ? ?? ??? ??, ??? ?? ??(Accelerated Approval)? ?? ??(Priority Review)? ?? ??? ?? ?? ??[3].
Gan & Lee ??
Gan & Lee? ?? ??? ?? ??? ?? ???? ???? ? ????. Gan & Lee? ?? ???? glargine ??(Basalin(R)), ??? ???? lispro ??(Prandilin(R)), ?? protamine zinc lispro ??(25R) (Prandilin(R)25), ??? ???? aspart ??, aspart 30 ?? ? ??? ?? ?(??? ??) ?? ??? ???? ???? ?? ?? ???? ??? ????? ????. ?? ??? ???? www.ganlee.us? ????.
??:
1. Thakkar JP, et al. (2014). Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol Biomarkers Prev 23(10), 1-25.
2. Ostrom Q, et al. (2018). Chapter 2: Brain Metastases: Epidemiology. In Schiff ED, Van den Bent MJ, Handbook of Clinical Neurology, Vol. 149 (3rd series) Metastatic Disease of the Nervous System (pp. 27-42). Elsevier BV.
3. US Food and Drug Administration. (2018, January 04) Fast Track [Press release]. Retrieved from .
??:
Hollie Brissenden
+44 (0)560 364 0404
??: Gan & Lee Pharmaceuticals Co., Ltd.