|
미FDA 임상시험 종료
본원 원장님이 미국에서 개발하신 아피톡스 [한국명:아피톡신]은 1983년 미국에서 개발을 시작하여 장장 33년만에 FDA임상시험을 완료하였습니다. 앞으로의 신약 허가 과정은 다음과 같습니다.
○ 2016.12.02 Officially LPLV(last
patient last visit) follow-up
○ 2016.12~2017.1 Data Collection
& Analysis
○ 2017.01.31 Phase III, CSR (Clinical Study
Report)
○ 2017.2-4 pre-BLA/NDA
Meeting
○ 2017.7 CDER, BLA Submission
○ 2018.2Q Approval for Marketing
Apitox - New Biological Drug] (Expect to be Approve)
KFDA – Apitoxin [한국 식약청 - 신약허가 받음]
|
Stage
|
Pre-Clinical
|
Phase I
|
Phase Ⅱ
|
Phase Ⅲ
|
NDA
| |
By
|
Bando Ph.
IPI *
|
Bando Ph.
IPI
|
Bando/Guju
IPI
|
Guju Ph.
Apimeds
|
Guju Ph.
Apimeds
| |
Year
|
1990~1993
|
1994
|
1995~1996
|
2000~2002
|
2003.5.3.
| |
Contents
|
Antigenecity
& Toxicity
|
20 Human
Tox. Safety
|
161 Human
Efficacy
|
407 Human
4 Universities
|
New Drug
Approved
| |
Results
|
Good
Results
|
Good
Safety
|
Good
Efficacy
|
Very Effective
|
한국 식약청
|
*** Phase IV 2003-2009
3,194 Cases Completed ***
FDA (US) - Apitox
|
Stage
|
Pre-Clinical
|
Phase I
|
Phase II
|
Phase III
|
BLA
| |
By
|
IPI
|
IPI
|
IPI
Apimeds
|
Apimeds
Radiant(CRO)
|
Apimeds
FDA/CBER**
| |
Year
|
1983~1986
* 2008. 1~6
Supp (1)
|
1986
|
1989~1990
** 09. 5~10.3
Supp (2) P.II
|
2013.1 ~
2016.11
|
Latest by 2017.12
| |
Contents
|
Toxicity
Tests
|
15 Human
Toxicity &
Safety
|
180 Human
Efficacy
Study
|
980 Screen
369 Valuable
USA 20 MC
|
DMF BB-MF
#13,130
(2006.9.19)
| |
Results
|
Safe
|
Good
Safety
|
Excellent
Efficacy
| |
|
> 커뮤니티 > 공지사항
