Investor Presentaiton slide image

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 23
View entire presentation