Ascentage Pharma Announces Clinical Trial Application for Olverembatinib (HQP1351) Approved in Canada

SUZHOU,China and ROCKVILLE,MD,July 22,2022 -- Ascentage Pharma (6855.HK),a global biopharmaceutical company engaged in developing novel therapies for cancers,chronic hepatitis B (CHB),and age-related diseases,today announced that the Phase Ib study of Ascentage Pharma's novel drug candidate,olverembatinib (HQP1351),for the treatment of patients with refractory chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) has been approved by Health Canada,making it Ascentage Pharma's first clinical study in the country.

This open-label,multicenter,randomized,global Phase Ib 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),accelerated-phase (AP),or blast-phase (BP) or with Ph+ ALL,who are resistant or intolerant to at least two tyrosine kinase inhibitors (TKIs).

CML is a hematologic malignancy of the white blood cells. The commercialization of BCR-ABL TKIs has revamped 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 that can safely and effectively target 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 CML resistant to first- and second-generation TKIs. It can effectively target a spectrum of BCR-ABL mutants,including the T315I mutation. As the first approved third-generation BCR-ABL inhibitor in China and the second globally,olverembatinib is a novel therapeutic with global "best-in-class" potentials. The clinical results of olverembatinib in hematologic malignancies have been selected for oral presentations at the American Society of Hematology (ASH) Annual Meetings for four consecutive years since 2018,and was nominated for "Best of ASH" in 2019. To date,olverembatinib has been granted 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 Zhai,Chief Medical Officer of Ascentage Pharma,commented,"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 olverembatinib's potential efficacy and safety,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 work full speed on the global clinical development of olverembatinib to allow more patients to benefit from this novel therapeutic as soon as possible."

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers,chronic hepatitis B,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 (TKIs). 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 50 Phase I/II clinical trials in the US,Australia,Europe,and China. Olverembatinib,the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML),was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition,olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA,and an Orphan Designation by the EU. To date,Ascentage Pharma has obtained a total of 15 ODDs,2 FTDs,and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 ODD from the EU for four of the company's investigational drug candidates. Ascentage Pharma has been designated for multiple Major National R&D Projects,including 5 National Major New Drug Discovery and Manufacturing projects,1 New Drug Incubator status,4 Innovative Drug Programs,and 1 Major Project for the Prevention and Treatment of Infectious Diseases.

Leveraging its robust R&D capabilities,Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology 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 discovering,developing,launching,and commercializing innovative drugs and is setting up world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs,in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law,Ascentage Pharma undertakes no obligation to update or revise publicly 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 unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article,statements of,or references to,our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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