SUZHOU, China and ROCKVILLE, Md., Nov. 9, 2020 — Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the results from two pivotal Phase II studies of the company’s novel BCR-ABL inhibitor, HQP1351 (olverembatinib), have been accepted for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. Qian Jiang, M.D., who will be presenting, and Xiaojun Huang, M.D. from the Hematology Department of Peking University People’s Hospital, are the principal investigators of these studies. Following the data releases in 2018 and 2019, this will be the third time that Ascentage Pharma has presented updated clinical data of HQP1351 at the ASH Annual Meeting. Being accepted by ASH for oral presentation for three consecutive years signifies the recognition of HQP1351’s safety and efficacy profiles by the international hematology community.
The 62nd ASH Annual Meeting will be held in a virtual format online from December 5 to 8, 2020. The ASH Annual Meetings are the largest gathering of the international hematology field, bringing together the latest and most cutting-edge research and development in hematology.
HQP1351 is a novel third-generation BCR-ABL tyrosine kinase inhibitor (TKI) being developed by Ascentage Pharma for the treatment of patients with chronic myeloid leukemia (CML) resistant to first- and second-generation TKIs. The results that will be released through the oral presentation are from the two pivotal Phase II trials of HQP1351 in patients with TKI-resistant and T315I-mutant CML. As of March 23, 2020, the pivotal Phase II HQP1351-CC201 trial enrolled a total of 41 patients with CML in the chronic phase (CML-CP); and as of February 11, 2020, the pivotal Phase II HQP1351-CC202 trial enrolled a total of 23 patients with CML in the accelerated phase (CML-AP). Results from those two trials of HQP1351 have shown favorable efficacy and tolerability in patients with TKI-resistant and T315I-mutant CML-CP and CML-AP.
Based on the results from these two pivotal Phase II trials, Ascentage Pharma submitted a New Drug Application (NDA) for HQP1351 for the treatment of patients with T315I-mutant CML-CP and CML-AP in China this year. The NDA has been subsequently granted Priority Review status.
Title: Novel BCR-ABL1 Tyrosine Kinase Inhibitor (TKI) HQP1351 (Olverembatinib) Is Efficacious and Well Tolerated in Patients with T315I-Mutated Chronic Myeloid Leukemia (CML): Results of Pivotal (Phase II) Trials
Session: 632: Chronic Myeloid Leukemia: Therapy: CML: New and Beyond
Presenter: Qian Jiang, MD
Time: Monday, December 7, 12:30 PM (PST) / Tuesday, December 8, 4:30 AM (Beijing Time)
Format: Channel 4 (virtual meeting)
About HQP1351 (Olverembatinib)
Being developed by Ascentage Pharma, HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target a spectrum of BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. At present, a New Drug Application for HQP1351 has been submitted in China, and the application was subsequently granted the Priority Review status. In July 2019, HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. In May 2020, the drug candidate was granted an Orphan Drug Designation and a Fast Track Designation by the US FDA. Furthermore, a Phase Ib trial of HQP1351 in patients with gastrointestinal stromal tumor (GIST) is also ongoing in China.
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. HQP1351, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia has been granted an Orphan Drug Designation (ODD) and a Fast Track designation by the US Food and Drug Administration (FDA), and a New Drug Application for the drug candidate has been submitted in China. To date, Ascentage Pharma has obtained a total of six ODDs from the FDA for four of the company’s investigational drug candidates.
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