Investor Presentaiton
Pemazyre® (Pemigatinib, IBI-375) Development Plan Overview
Commercial Stage FGFR1/2/3 Inhibitor with Best-in-class Profile
Enzyme Inhibitory Activity of IBI-375 (FGFR1/2/3)
Parameter
Assay Type
IBI-375
BGJ398¹
TAS-120²
ARQ 0873 JNJ-427564934
FGFR1 IC50 (nM)
Enzyme
0.4
0.9
3.9
4.5
1.2
Desired
FGFR2 IC50 (nM)
Enzyme
0.5
1.4.
1.3
1.8
2.5
target activity
FGFR3 IC 50 (nM)
Enzyme
1.2
1
1.6
4.5
3
FGFR4 IC50 (nM)
Enzyme
30
60
8.3
34
5.7
Off-target
activity
VEGFR2 IC50 (nM)
Enzyme
71
180
UNK
21
36.8
H-1581 (FGFR1 amp Lung Ca)
KG-1A (FGFR1 translocated MPN)
Cell viability
14
Cell viability
3
KATO-III (FGFR2 amp Gastric Ca) Cell viability
RT-112 (FGFR3-TACC3 Bladder Ca) Cell viability
3
7
5
PemazyreⓇ (pemigatinib) Development Program Overview
Clinical
130
Cellular
potency
200
0.1
progress
UNK
650
1.3
2L mCCA (cholangiocarcinoma)
Approved in Taiwan market for 2L mCCA in 2021.06
NDA for 2L MCCA in mainland China accepted by the NMPA in
2021.07
NDA for 2L MCCA in Hong Kong market accepted by the Drug
Office of HK DOH in 2021.07
.
1L MCCA
1. Guagnano et al (2011) J. Med. Chem; 2. Babina & Turner (2017), Nature Reviews Cancer; 3. Hall et
al (2016) PLOS ONE 11(9); 4. Lorenzi et al (2017) Molecular Cancer Therapeutics
Fight202 study: IBI-375 in Patients with Previously Treated
Cholangiocarcinoma outside China
Joined Incyte-sponsored global Phase 3 trial (FIGHT-302) for IBI-
375 for 1L mCCA
To release phase 2 data of 2L mCCA at ESMO 2021
1.0
PFS
0.9
1.0
0.9-
0.8
0.8-
0.7
Median PFS (95% CI), mo
0.7-
0.6-
Cohort A
6.9 (6.2-9.6)
0.6-
0.5
Cohort B
2.1 (1.2-4.9)
0.5-
OS
Median OS (95% CI), mo
Cohort A
Cohort B
-Cohort C
2L MCCA
21.1 (14.8-NE)
6.7 (2.1-10.6)
4.0 (2.3-6.5)
2021 plan
0.4
0.4-
Cohort C
1.7 (1.3-1.8)
0.3
0.3-
0.2
0.2-
0.1
0.1-
0
0
D
2
4
6
8
10
12
14
16
18
20
22
24
0
2
4
6
8
10
12
14
16
18
20 22 24 26
Abou-Alfa GK, et al. Lancet Oncol. 2020 May;21(5):671-684.
Innovent
Pemigatinib exhibits a best-in-class profile with excellent potency for FGFR 1, 2, and 3.
Approved in Taiwan market, NDA accepted in mainland China and Hong Kong.
Confidential
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