1031021012 1021014 National Research Program for
Biopharmaceuticals
102.10*
102.10*
(2012) (Clinical Proof-of-Concept) 10310 (Research
Proof-of-Concept) 5 (Clinical Proof-of-Concept)
102.10*
102.10*
103
102.10*
103Small-Molecules, Protein Drugs(Antibodies), Medical Device,
Biomarkers.Stages of Development: emphasis on the Late
Stage.Criteria of Evaluation: Scientific Innovation, IP Protection,
Commercial Potential, International Competitiveness.Assistance from
NRPB: Pre-Clinical Development, IP Consultation, Regulatory
Issues.
102.10*
7918341945673100101100100101102150 1491463
1011011026110110110261 ()(Stage)(Stage)()
102.10*
102.10*
new indication/drug repurposing/new formulation/new route of
administration/new combinationclinical
proof-of-concept2-3Predictive Biomarker2-3//drug delivery
systemnanomedicine
102.10*
2leadsnoveltypotential impact2-3candidates2-3IND
102.10*
(1)initial hitsleads2high-performance
leadsleadsIC50mMTherapeutic Index (in vitro or in vivo)
3candidates3-5high-performance leads/potential
candidatesleadspotential candidates1-3Therapeutic Index (in vitro
or in vivo) 1candidate
102.10*
// (2)
102.10*
SensitivitySpecificity2-3/
102.10*
/QC/QAGMP/ISO Compliance2-3/
102.10*
(30%) (35%)// (15%) (20%)/
102.10*
102.10*
102.10*
&
/Year2014Year2015Year2016Year2017A. In Vitro & In Vivo
Pharmacology
B. Acute Toxicity
C. Pre-Formulation Testing
A. Pharmacokinetic StudyA1. In Vitro ADMEB. Toxicology Study
& Safety Pharmacology StudyB1. AMES TestB2. 28-Days Repeated
Dose Toxicity Study in Rats
102.10*
(Specific Aims) () (1)NRPBStage 2Stage 3 (1.5) (1) (1)/ (1)
102.10*
NRPB
102.10*
http://118.163.140.80/nrpb/index.php 1021018-102111417:00
102.10*
65 65 144234
102.10*
102.10*
()
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102101714:00-16:00100210F(1004811)10210189:00-11:004400(70403138)
102.10*
NRPB
102.10*
NRPB
102.10*
Thank You forYour Attention
102.10*
Q & A (1)NRPB??3?concept
102.10*
? 100? ?103lead to candidate/candidate to INDNRPBQ & A
(2)
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5? ?103511021210321034?
Q & A (3)
102.10*
102.10*
NRPB (1027)
102.10*
-1C1- C2- C5- E2- E3- NCHC-
GP1 GP TMT (C1, C2, C5, E2, E3, NCHC*)D3 ()AM1Research Proof of
ConceptAM2AM3AM4CS1 5PC DMPKCGMP INDDMPKGLPBiologics
102.10*
-2
SB1
SB2SB3SB4TR6-1TR6-2TR6-3protocolIRBCDETR1TR2TR4TR5TR7-14()IRB
102.10*
102111410211~121021210321032~3103410351
