SUZHOU, China and ROCKVILLE, MD, July 21, 2022 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in the development of novel therapies for cancer, chronic hepatitis B (CHB) and age-related diseases, today announced that the Phase Ib study of Ascentage Pharma’s new drug candidate, olverembatinib (HQP1351), for the treatment of patients with refractory chronic myeloid leukemia (CML) or philadelphia cream Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) has been approved by Health Canada, making this Ascentage Pharma’s first clinical study in the country.

Ascentage Pharma logo (PRNewsfoto/Ascentage Pharma)

This phase Ib, multicenter, randomized, global, open-label study is designed to evaluate the safety, efficacy, pharmacokinetics (PK) and determine the recommended phase II dose (RP2D) of olverembatinib in patients with CML in chronic phase (CP), in accelerated phase (AP), in blast phase (BP) or with Ph+ ALL, resistant or intolerant to at least two tyrosine kinase (TKI) inhibitors.

CML is a hematological malignancy of the white blood cells. The commercialization of BCR-ABL TKIs has reorganized the treatment of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance. Currently, there is an urgent unmet medical need for a new generation of TKIs capable of safely and effectively targeting the BCR-ABL mutation.

Olverembatinib is a novel, orally active, third-generation BCR-ABL inhibitor developed by Ascentage Pharma for the treatment of patients with first- and second-generation TKI-resistant CML. It can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. As the first third-generation BCR-ABL inhibitor approved in China and second globally, olverembatinib is a new drug with global “best-in-class” potentials. Clinical results of olverembatinib in hematological malignancies have been selected for oral presentations at the annual meetings of the American Society of Hematology (ASH) for four consecutive years since 2018, and have been nominated for “Best of ASH” in 2019. To date, olverembatinib has received three orphan drug designations from the US FDA for the treatment of CML, ALL, and acute myeloid leukemia (AML); and an orphan designation by the EU, for the treatment of CML.

dr. Yifan ZhaiMedical Director of Ascentage Pharma, said, “Overcoming drug resistance in the treatment of CML has long been an imperative for the global hematology community. This approval for the study of olverembatinib in Canada is indicative of the growing recognition of the potential efficacy and safety of olverembatinib, and are the results of our continued global expansion. It is also an important milestone for the development and commercialization of this investigational drug. We will be working at full speed on the global clinical development of olverembatinib to enable more patients to benefit from this new treatment as soon as possible. »

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global biopharmaceutical company engaged in the development of new therapies for cancers, chronic hepatitis B and age-related diseases. On October 28, 2019Ascentage Pharma was listed on the main board of the Stock Exchange of Hong Kong Limited under stock code 6855.HK.

Ascentage Pharma is focused on developing therapies that inhibit protein-protein interactions to restore apoptosis or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including highly potent new Bcl-2 inhibitors and dual Bcl-2/Bcl-xL inhibitors, as well as candidates targeting the IAP and MDM2-p53 pathways, and tyrosine next-generation kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key regulators of apoptosis. The company is conducting more than 50 phase I/II clinical trials in the United States, Australia, Europeand China. Olverembatinib, the company’s lead drug candidate being developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted Priority Review status and Breakthrough Therapy Designation (BTD) by the Assessment Center (CDE) from the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, olverembatinib has also received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA, as well as an Orphan Drug Designation from the EU. To date, Ascentage Pharma has obtained a total of 15 SDGs, 2 FTDs and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 SDG from the EU for four of the Company’s investigational drug candidates. Ascentage Pharma has been designated for several major national R&D projects, including 5 major national new drug discovery and manufacturing projects, 1 new drug incubator status, 4 innovative drug programs and 1 major project for prevention and treatment. treatment of infectious diseases.

Leveraging its strong R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with many renowned biotech and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca and Pfizer. The company has built a talented team with global experience in the discovery, development, launch and commercialization of innovative medicines and is building world-class commercial manufacturing and sales and marketing teams. One of Ascentage Pharma’s main objectives is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfill its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-looking statements

Forward-looking statements made in this article relate only to events or information as of the date the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unforeseen events. You should read this article in its entirety and be aware that our actual future results or performance may differ materially from what we expect. In this article, statements or references to our intentions or those of any of our directors or our company are made as of the date of this article. Each of these intentions may change in light of future development.



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