Ascentage announced that it received approvals for initiating Phase Ib/II clinical trials of APG-2575 for r/r CLL/SLL and WM in the US, and for conducting Phase Ib trial of APG-2575 for r/r AML in China. We expect the drug to obtain approvals in China and the US by 2023E. Maintain BUY with our DCF-based TP unchanged at HK$45.8.
- APG-2575 received approvals for initiating three different trials in the US and China. The US FDA approved the Company to conduct a Phase Ib/II trial of APG-2575 as a single agent or in combination with rituximab/ acalabrutinib for r/r CLL/SLL; and a Phase Ib/II trial of APG-2575 as a single agent or in combination with ibrutinib/ rituximab for WM. The NMPA also approved the Company to conduct a Phase Ib trial of APG-2575 as a mono or combo therapy for r/r AML.
- Preliminary satisfactory safety and efficacy for APG-2575. In a dose-escalation study of APG-2575 as a single agent in multiple hematologic malignancies in the US and Australia, no DLT or TLS has been reported and the MTD has not been reached so far, implying favorable safety profile. For efficacy, as of 13 Aug 2019, three CLL patients in 400mg cohort had already showed a significant response to APG-2575 by the end of the first treatment cycle, where the absolute lymphocyte counts (ALC) of these three patients reached the criteria for CR. In addition, an assessment of one patient in the 50mg dose cohort found that the size of this patient’s lymph nodes at the end of cycle 6 had reduced by more than 60% compared to baseline, which met the criteria for PR.
- Strong in-house R&D capability in apoptosis pathways and next generation TKIs. Ascentage is developing novel small molecule drugs mainly for oncology. As of Jun 2019, Ascentage Pharma was conducting 28 phase I or II clinical trials in China, US and Australia. The most advanced drug was HQP1351, a third generation BCR-ABL/KIT inhibitor for drug resistance in current TKI treatments (imatinib, dasatinib and nilotinib). HQP1351 is under a pivotal phase II trial for CML in China and expected to receive approval from NMPA in 2021E. APG-2575, APG-1252, APG-115 and APG-1387 are in Phase I trials and expected to launch in 2023-24E.
