【Company Research】Ascentage Pharma Group (6855 HK) – Promising progress on HQP-1351 and APG-2575
- Positive data of HQP-1351 (Olverembatinib) released in the ASH annual meeting. Ascentage presented the data of two pivotal phase II studies of HQP1351 in patients with TKI-resistant and T315I-mutated CML-CP or CML-AP in oral presentation at the 62nd ASH meeting. For the evaluable CML-CP patients, 3m- and 6m-PFS were 100% and 96.7%, respectively, while its major cytogenetic response (MCyR) was 75.6% (including 65.9% of complete cytogenetic response (CCyR)) and major molecular response (MMR) was 48.8%. For the evaluable CML-AP patients, 3m- and 6m-PFS were 100% and 95.5%, respectively, while its major hematologic response (MaHR) was 78.3% (including 60.9% of complete hematologic response (CHR)) and MCyR, CCyR and MMR were 52.2%, 39.1% and 26.1%. The most frequent TRAE in both trials is thrombocytopenia (48.8% and 52.2%, respectively).
- High preliminary response rate of APG-2575 in chronic lymphocytic leukemia (CLL) patients. APG-2575 is a novel, orally administered small-molecule Bcl-2-selective inhibitor designed to treat hematologic malignancies and solid. In total, 9 clinical studies are ongoing globally, with over 100 patients who have been administered APG-2575 at doses ranging from 20 mg to 1,200 mg, among which over 30 patients with relapsed/refractory CLL were enrolled. In evaluable CLL patients, 70% have achieved ORR, with no dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS). Besides CLL, APG-2575 was also being evaluated for treatment of follicular lymphoma (FL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), acute myeloid leukemia (AML), and high leukocyte acute leukemia (HCL) and Waldenström macroglobulinemia (WM). Moreover, APG-2575 has obtained Orphan Drug Designations from the US FDA for treatment of CLL, MM and WM.
- Prepared for the commercialization of HQP-1351. The Company recently appointed Mr. Gang Zhu (祝刚) as Chief Commercial Officer (CCO) to lead commercial initiatives. Mr. Zhu has rich experiences in commercializing innovative hematologic cancer drugs and solid tumor drugs, and owns proven track record in building and adapting commercial organizations. In our view, by the end of 2021E, Ascentage will build up a commercialization team with over 100 sales to cover more than 1,000 hospitals for the promotion of its first commercialized product, HQP-1351.
- Maintain BUY. We forecast HQP-1351 to obtain NMPA’s approval in 2021E. Maintain BUY with TP of HK$70.7 unchanged based on an 8-year DCF valuation (WACC: 10.98%, terminal growth of 3.0%).
