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SUZHOU, China and ROCKVILLE, Md., Jan. 11, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a commercial stage global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that Dr. Dajun Yang, the company's Chairman and CEO, gave a speech at the 42nd Annual J.P. Morgan Healthcare Conference. In the presentation, Dr. Yang provided an update on Ascentage Pharma's recent major milestones and the formidable competitiveness the company has built in the field of hematologic malignancies, all achieved under its patient-centric global innovation strategy.
Approvals for multiple global registrational Phase III trials mark new milestones in global innovation
As an innovative drug company pursuing a patient-centric global innovation strategy, Ascentage Pharma has achieved major milestones with its global expansion in 2023, including approvals for multiple global registrational Phase III studies of olverembatinib (HQP1351) and lisaftoclax (APG-2575), two of the company's key drug candidates.
In-house developed by Ascentage Pharma, the novel drug olverembatinib is the first and only China-approved third-generation BCR-ABL inhibitor that filled a major treatment gap for Chinese patients with drug-resistant CML. In July 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved a global registrational pivotal Phase III study of olverembatinib, Ascentage Pharma's lead drug candidate, in combination with chemotherapy versus imatinib in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This approval marks a major milestone that could potentially pave the way for olverembatinib to become the first tyrosine kinase inhibitor (TKI) approved in China for the treatment of patients with Ph+ ALL in the first-line setting.
In August 2023, the US Food and Drug Administration (FDA) cleared a global registrational pivotal Phase III study of the Bcl-2 inhibitor lisaftoclax, another one of Ascentage Pharma's key drug candidates, in previously treated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This regulatory clearance marked a major step in the global clinical development of lisaftoclax as it can potentially accelerate the drug's journey to market as the world's second approved Bcl-2 inhibitor, further validating the company's capabilities in innovation and global clinical development.
Two months after that, lisaftoclax achieved another breakthrough with a clinical trial approval by the China CDE for a global registrational pivotal Phase III study of lisaftoclax combined with the Bruton's tyrosine kinase (BTK) inhibitor acalabrutinib, versus immunochemotherapy for the first-line treatment of naïve patients with CLL/SLL.
Olverembatinib approved for a new indication while having its global first-in-class potential further validated
Ever since launching olverembatinib, Ascentage Pharma has stepped up the commercialization of the drug and achieved a range of breakthroughs. In January 2023, as a frontrunner among National Major New Drug Development designated drugs in China, olverembatinib was included into the China 2022 National Reimbursement Drug List (NRDL), thus saw its accessibility and affordability drastically improved.
In November 2023, the NMPA approved a new indication of olverembatinib for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation TKIs, allowing a broader population of patients with CML to benefit from the drug.
At the recently concluded 2023 American Society of Hematology (ASH) Annual Meeting, eleven abstracts on olverembatinib were selected for presentations, including two Oral Presentations, making 2023 the sixth consecutive year in which data of olverembatinib were selected for Oral Presentations at the meeting. This is another indication of the strong global best-in-class potential of olverembatinib.
Data from the Chinese study of olverembatinib (HQP1351CC203), selected for an Oral Presentation at ASH 2023, showed that in patients with CML-CP resistant and/or intolerant to prior treatment with TKIs, the olverembatinib arm achieved statistically significant improvement in event-free survival (EFS) compared to the control arm that was treated with the best available therapy (BAT), thus meeting the primary endpoint of the study with markedly improved prognosis for patients with CML in the olverembatinib arm, compared to those in the control arm.
Meanwhile, results from the US study of olverembatinib were equally encouraging. After releasing preliminary results of the US study in an Oral Report at the ASH Annual Meeting in 2022, at ASH 2023, Ascentage Pharma presented updated data from a larger patient sample that showed the favorable clinical benefit and tolerability of olverembatinib, as a monotherapy and in combinations, in heavily pretreated patients with CML and Ph+ ALL, particularly those who have failed prior treatment with the third-generation TKI ponatinib or the allosteric STAMP inhibitor asciminib. These results suggest that olverembatinib has global potential as an effective new therapy for patients with CML or Ph+ ALL.
The company is extensively exploring and validating olverembatinib's therapeutic potential in indications other than CML, and the drug has shown particularly promising utility for the treatment of Ph+ ALL. Results from multiple studies evaluating olverembatinib in patients with Ph+ ALL were presented at ASH 2023, including an Oral Presentation featuring a study that showed encouraging clinical benefit and favorable tolerability of olverembatinib, a potent third-generation TKI, combined with reduced-intensity chemotherapy in patients with Ph+ ALL, indicating the regimen has the potential of ushering in an era of chemotherapy-free treatment for Ph+ ALL.
While solidifying its presence and competitiveness in hematologic malignancies, Ascentage Pharma has also expeditiously advanced its clinical development of olverembatinib for the treatment of gastrointestinal stromal tumor (GIST). In 2023, the second year in which clinical results of olverembatinib in patients with GIST were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, Ascentage Pharma released data that showed encouraging clinical benefit and favorable safety of olverembatinib in patients with TKI-resistant succinate dehydrogenase (SDH)-deficient GIST.
Bcl-2 inhibitor lisaftoclax showed promising clinical benefit for patients with CLL and strong therapeutic potential in AML and MM
Also during his speech, Dr. Yang reviewed the recent progress in the development of lisaftoclax, alluding to key data released at ASH 2023.
As the first Bcl-2 inhibitor that has entered registrational pivotal trials in China and the second globally, lisaftoclax is a novel therapeutic with global best-in-class potential.
At ASH 2023, Ascentage Pharma released results from three studies of lisaftoclax, including one study in patients with relapsed/refractory (R/R) CLL that showed an overall response rate (ORR) of 73.3%; a complete remission (CR)/CR with incomplete blood count recovery (CRi) rate of 24.4%; and a positive correlation between CR/CRi rate and dose levels, in patients who received lisaftoclax. In addition, the study observed a low incidence of tumor lysis syndrome (TLS) that is comparable to the results of earlier studies. While in long-term follow-up, the study observed a 30-month overall survival (OS) rate of 86.3% that indicated the drug's high response rates, safety for long-term use, and potential in bringing durable survival benefit to patients with CLL.
In addition, Ascentage Pharma released the first dataset of lisaftoclax in patients with multiple myeloma (MM) and acute myeloid leukemia (AML) at ASH 2023. These data revealed strong therapeutic potential and provide a solid foundation for the continued development of lisaftoclax in indications outside CLL. Dr. Yang also mentioned in his speech that a registrational Phase III study of lisaftoclax in AML has already been approved by the China CDE and is being initiated.
Accelerating global innovation to achieve enhanced global competitiveness
Under its overarching global innovation strategy, Ascentage Pharma has built a rich pipeline composed of highly promising drug candidates with first-in-class and/or best-in-class potentials, and is conducting more than 40 clinical studies in China, the US, Australia, Europe, and Canada. The company's innovative and clinical development capabilities have received growing recognition from the global research community as the clinical data on a number of its drug candidates were frequently showcased at major international congresses.
In his talk, Dr. Yang outlined a series of potential catalysts for 2024, including the FDA clearance for the registrational Phase III study of olverembatinib, NDA submissions for lisaftoclax, rapid progress with multiple global registrational Phase III studies, and the NRDL inclusion of olverembatinib's new indication.
"It is my great pleasure to attend the annual J.P. Morgan Healthcare Conference this year and have the opportunity to provide an update on the key progress we delivered in 2023," said Dr. Dajun Yang. "In the past year, we received clearance for multiple global registrational Phase III studies, taking major steps forward in our global expansion; we continuously expanded the target indications of our core drug candidates and further solidified our leadership position in the arena of hematologic malignancies. Moving forward, we will continue to execute our global innovation strategies, accelerate our global registrational Phase III studies, and make further strides fulfilling our mission of addressing unmet clinical needs in China and around the world for the benefit of more patients."
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 9 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 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.
Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) Designations from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates.
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, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its 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.
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