Investor Presentaiton
IBI-376 (PI3KS) Development Plan Overview
IBI-376 demonstrated a high rate of rapid and durable
response in r/r FL and r/r MZL
Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular
Lymphoma (CITADEL-203) (ASH 2020)
Percentage Change From Baseline
50-
40-
30-
20
10
0
-10-
-20-
-30
-40-
Weekly Group
Daily Group
-50-
-60-
-70-
-80-
-90-
-100
90% (106/118) of efficacy evaluable All Treated Patients and 91% (86/95) of efficacy evaluable
patients in the Daily Group had tumor regression at target lesions
Efficacy Evaluable
All Patients
(86 Responders)
Median DOR (95% CI), months
15.9 (12.0-NE)
Efficacy Evaluable
Daily Group
(71 Responders)
14.7 (12.0-17.5)
Overall ORR: 73% (95% CI: 64-81)
Efficacy Evaluable All Treated Patients (N=118)*
2% 3%
IBI-376 (parsaclisib) Development Program Overview
Preliminary ORR by IRC
Clinical
DG ORR: 75% (95% CI: 65-83)
Efficacy Evaluable DG (N=95)*
2% 2%
progress
6%
CR
14%
CR
PR
15%
SD
SD
PD
NE
NA
14%
CR
17%
SD
59%
PR
Efficacy Evaluable
61%
PR
77% of responses occurred at first assessment
ORR by investigator assessment efficacy evaluable All Treated Patients 73% (95% CI: 64-81)
Efficacy Evaluable
Daily Group
(N=95)
15.8 (13.8-19.1)
All Patients
(N = 118)
Median PFS (95% CI), months
15.8 (13.2-19.3)
WG: 20mg, qd, 8 weeks; 20mg, qw afterward; DG: 20mg, qd, 8 weeks; 2.5mg, qd afterward;
Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal
Zone Lymphoma (CITADEL-204) (ASH 2020)
2021 plan
r/r FL and MZL
Started patient enrolment of pivotal Phase 2 trial for IBI-376 for
r/r FL and MZL in China in Apr 2020
Myselofibrosis
Filed IND application for IBI-376 in China for Incyte-sponsored
global Phase 3 trial for 2L myselofibrosis in end 2020
Plan to start patient enrolment of IBI-376 in China for Incyte-
sponsored global Phase 3 trial for 2L myelofibrosis in 2021
Plan to complete patient enrolment of IBI-376 for pivotal Phase 2
trial for r/r FL and MZL in China
Plan to submit NDA to NMPA for IBI-376 for r/r FL between late 2021
to early 2022
Efficacy Compared within Different PI3K Inhibitors
IRC Assessment
ORR: 57.0%
ORR: 56.9%
95% CI: 46.7-66.9
95% CI: 44.7-68.6
70%
50%
40%
51.0%
30%
51.4%
PR
20%
30.0%
SD
10%
6.0%
31.9%
SD
5.6%
est Percentage Change From Baseline
100-
80-
60-
40
20-
0
-20-
-40-
-60-
-80-
-100-
Target lesion size
Spleen size
Medicine
Target
Parsaclisib
(US data)
PI3Kō
Incyte
Idelalisib
PI3Kō
Gilead
Duvelisib
PI3Kō, Y
Infinity
.
All Treated Patients
(N = 100)
Daily Group
(N=72)
CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease.
67% (38/57) of responders had an objective response (CR or PR) at first assessment
Median time to first response was 8.1 weeks
Umbralisib
PI3Kō
All Treated Patients
(57 Responders)
Daily Group
(41 Responders)
Median DOR (95% CI), months
12.0 (9.3-NE)
NR (8.1-NE)
Median PFS (95% CI), months
All Treated Patients
(N = 100)
19.4 (13.7-NE)
Daily Group
(N = 72)
NR (11.0-NE)
Copanlisib
PI3K
Bayer
NE, not evaluable; NR, not reached.
Co.
DLBCL (n)
30% (23)
Efficacy-ORR, %
FL (n)
73% (118)
MCL (n)
67% (9)
MZL (n)
57% (100)
NA
54% (72)
40%
57%
NA
41%*(83)
NA
33% (18)
TG
27% (11)
45% (22)
79% (11)
Therapeutics
NA
NA
25% (40)
58.7% (104)
64% (11)
69.6 %
IBI-376 (PI3KS) is a highly selective, potent and differentiated PI3K inhibitor designed to reduce hepatotoxicity.
IBI-376 shows the Best-in-Class potential in multiple B cell malignancies; pivotal Phase 2 trial is ongoing in China.
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