Ascentage Pharma Group International (NASDAQ:AAPG, HKEX: 6855))), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, today announced results from a Phase Ib study evaluating olverembatinib (HQP1351), the company's core product, in combination with bispecific T-cell engager antibody (immunotherapy) blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL) were presented in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
The ASCO Annual Meeting is the world's most prominent scientific gathering in the clinical oncology community, showcasing cutting-edge research in clinical oncology and advanced cancer therapies. This year marks Ascentage Pharma's ninth consecutive appearance at the ASCO Annual Meeting. A total of six studies involving three of the Company's key assets were selected for presentation, including three rapid oral presentations.
Data from this rapid oral presentation marks the first disclosure of olverembatinib combined with blinatumomab in international patients. The combination regimen demonstrated encouraging clinical activity in patients with relapsed/refractory Ph+ BCP-ALL or CML-LBP, with strong response rates and minimal residual disease (MRD) clearance. In terms of safety, the combination regimen was generally well tolerated, with a safety profile consistent with individual agent toxicities.
Olverembatinib is a novel drug developed by Ascentage Pharma and represents the first third-generation BCR-ABL inhibitor approved in China. Olverembatinib is currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. The drug is currently approved in China for: adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs, with all approved indications now covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III studies to evaluate olverembatinib in multiple indications, including CML-CP, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), with two of these studies having been cleared by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ascentage Pharma has signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.
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