Investor Presentaiton
IBI-306 (PCSK9) Development Plan Overview
First China-developed PCSK9 at Multiple Phase 3 Studies
Data of SAD and MAD
IBI-306 Development Program Overview
HeFH
Phase 3 study for HeFH met primary endpoint in 2021.08
Non-FH
Have completed patient enrollment for Phase 3 in China for
Non-FH
The point estimate and 95% confidence interval for the difference in percent reduction from baseline in LDL-C at 12 weeks
for each dose group compared with placebo are as follows:
75 mg Q2W: -58.91% (-76.54%, -41.28%)
140 mg Q2W: -51.89% (-70.09%, -33.68%)
300 mg Q4W: -57.73% (-72.89%, -42.57%)
420 mg Q4W: -69.85% (-84.43%, -55.26%)
450 mg Q6W: -59.95% (-78.81%, -41.10%)
600 mg Q6W: -54.11% (-73.78%, -34.44%)
Percent change in LDL-C
from baseline, mean (SE)
20-
-20-
-40-
-50-
-60-
Phase 1: Percentage Change from Baseline in LDL-C Levels
•
Clinical
•
progress
75 mg SC
→ 75 mg IV
o
150 mg SC
300 mg SC
450 mg SC
450 mg IV
2021 plan
-
600 mg SC
Placebo
-80
0
8
15 22 29 36 43
57
71
85
Days after single dose
The safety profile of IBI-306 in MAD is consistent
with that in SAD
Incidence of TEAE between IBI-306 and
placebo group is similar.
No SAE is reported.
In SAD/MAD studies, IBI-306
demonstrated good efficacy/ safety
profile, and the potential to be
developed as a long-acting PCSK9
inhibitor.
Percent change in LDL-C
from baseline, mean (SE)
20-
-20-
-40-
-50-
-60-
Phase 2: Percentage Change from Baseline in LDL-C Levels
-80
0
15
29
43
57
71
85
Days after first dose
Non-FH
Will keep following up the registrational trials of IBI-306
in Non-FH
Comparison with other PCSK9 in China
Imported PCSK9i
Amgen, Sanofi
Other Domestic PCSK9i
IBI-306
Innovent
Status
Ph3
On market
75 mg Q2W
140 mg Q2W
HoFH
HoFH
o
300 mg Q4W
420 mg Q4W
Indications
HeFH
Non-HF
450 mg Q6W
→ 600 mg Q6W
-Placebo
Duration
Efficacy
Safety
Patient Size in China
Q4W or Q6W
50-70% LDL-C decreased
1200
HeFH
Non-FH
Q2W or Q4W
50-70% LDL-C decreased
Comparable with each other
300-500
Ph1/Ph2/Ph3
HoFH
Mixed Dyslipidema
Q2W or Q4W
Not disclosed
Not disclosed
600-900
Compared with other PCSK9 inhibitors, IBI-306 has long-acting potential, good efficacy comparable to imported brands, and fastest clinical
progress among domestic PCSK9 in China, with the Phase 3 for HeFH already met primary endpoint.
Innovent
Confidential
Copyright©2021 Innovent Biologics
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