Investor Presentaiton
IBI-348 (Olverembatinib, BCR-ABL) Development Plan Overview
About-to-launch Third-generation BCR-ABL TKI at NDA Stage
IBI-348 (Olverembatinib) Differentiated Advantages
IBI-348 is an oral third-generation BCR-ABL1 inhibitor designed for
treatment of the patients with CML that is refractory to or intolerant of
tyrosine kinase inhibitors (TKIs).
IBI-348 is effective against a broad spectrum of BCR-ABL1 mutations,
including T3151, which confers resistance against all first- and second-
generation TKIS.
•
•
•
Clinical Highlights
IBI-348 shown highly and durably efficacious in heavily TKI-pretreated
patients with T3151-mutated CML-CP or CML-AP.
The probability and depth of clinical response may increase with
prolonged treatment period.
IBI-348 was well tolerated.
Clinical Highlights
Figure 1. Overview of efficacy in patients with CML-CP (Study CC201)
and CML-AP (Study CC202)
•
100-
CC201
CC202
Patients(%)
80-
60-
40-
20-
In CC201, as of the study cut-off date of
March 23, 2020, total 41 patients were
enrolled, across a median follow-up of 7.9
months, the mean 3-month PFS was 100%
and 6-month PFS 96.7%.
In CC202, as of the cut-off date of
February 11, 2020, total 23 patients were
enrolled, across a median follow-up of 8.2
months, the 3-month PFS was 100% and
the 6-month PFS 95.5%.
Clinical
progress
IBI-348 Development Program Overview
Entered into multifaceted collaboration with Ascentage Pharma,
including to co-develop and co-commercialize IBI-348 (Olverembatinib)
in Greater China
CML:
NDA of IBI-348 (Olverembatinib) was accepted by the China NMPA
in 2020.10 with priority review, for TKI-resistant and T3151+ chronic
phase CML and accelerated phase CML
0
CHR
MCYR
CCYR
MMR
•
Most adverse events were grade 1-2.
N for CC201
31
41
N for CC202
23
23
41
23
41
23
Blood (2020) 136 (Supplement 1): 50-51. https://doi.org/10.1182/blood-2020-142142
Novel BCR-ABL1 Tyrosine Kinase Inhibitor (TKI) HQP1351 (Olverembatinib) Is Efficacious and Well Tolerated in Patients
with T3151-Mutated Chronic Myeloid Leukemia (CML): Results of Pivotal (Phase II) Trials.
2021 plan
CML:
Anticipate to receive NDA approval of IBI-348 (Olverembatinib)
by end 2021
About-to-launch first China-developed third-generation BCR-ABL TKI to address the clear unmet medical needs in CML
patient population evolved with drug-resistance or intolerance to front line TKIs.
Innovent
Confidential
Copyright©2021 Innovent Biologics
23
23View entire presentation