SUZHOU, China and ROCKVILLE, Md., Jan. 11, 2022 /PRNewswire/ -- 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 Dr. Dajun Yang, the company's Chairman and CEO, delivered a presentation at the virtually-held 40th Annual J.P. Morgan Healthcare Conference in the evening of January 10, 2022 (Beijing Time), showcasing the company's recent milestone achievements and progress with its transformation from a biotech to a full-fledged biopharmaceutical company.
During the presentation, Dr. Yang first summarized key milestones the company achieved in 2021, including:
- The approval for the company's lead asset olverembatinib (HQP1351) in China marked a big step forward in the company's transition from a biotech to a biopharmaceutical company with commercialized products. Being the only third-generation BCR-ABL inhibitor approved for the treatment of drug-resistant chronic myeloid leukemia (CML) in China, olverembatinib addresses an important treatment gap in China, offering a clinical breakthrough that significantly improves the survival of patients with drug-resistant CML harboring the T315I mutation.
- The company also saw great progress with its apoptosis-targeted pipeline. Lisaftoclax (APG-2575), a Bcl-2-selective inhibitor and a lead candidate of this pipeline, was approved to enter a Phase II pivotal study in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) in China, thus became the world's second Bcl-2 inhibitor entering registrational studies.
- The company continued to forge ahead with its global innovation and clinical development. As of the end of 2021, lisaftoclax was being investigated in 18 clinical trials globally for the treatment of hematologic malignancies. Moreover, the company was granted a total of 16 Orphan Drugs designations (ODDs) by the US Food and Drug Administration (FDA) and the European Commission, and 2 Fast Track designations by the US FDA, further validating the company's capabilities in global innovation.
- The company successfully entered into multiple global strategic collaborations with a number of leading biopharmaceutical companies such as Pfizer and Innovent Biologics to further advance its pipeline development.
- The official inauguration of the company's global headquarters and R&D center, creating a strong base supporting the company's accelerating global expansion and its ongoing integration of internal and external resources, has extended Ascentage Pharma's competitive-edge in the innovative drug arena.
A 0-to-1 transformation that effectively addressed treatment gaps in China and officially opened the chapter on commercialization
As a pioneer in developing novel innovative drugs in China, Ascentage Pharma has built a rich and high-potential pipeline comprising a range of assets with first-in-class or best-in-class potential globally (Figure 1). At present, Ascentage Pharma is steadily advancing over 50 clinical trials globally.
Olverembatinib, the company's lead product, was approved in China in November 2021 and became the first approved third-generation BCR-ABL inhibitor in the country. This approval for olverembatinib effectively ended the lack of treatment options for Chinese patients with drug-resistant CML harboring the T315I mutation, a clinical gap that has long devastated families and communities in China. Meanwhile, the approval also officially opened an exciting chapter on commercialization for the company.
In July 2021, Ascentage Pharma and Innovent Biologics announced a multifaceted strategic collaboration including the joint development and commercialization of olverembatinib in China. In addition, the company has also entered into agreements with multiple well-established partners to advance the commercialization and maximize the accessibility of olverembatinib in a coordinated manner.
Progress in clinical development frequently featured at global scientific events, further demonstrating the best-in-class and first-in-class potential of the company's assets
Looking back at 2021, Ascentage Pharma achieved notable progress with many of its clinical trials. Results from these trials were featured at multiple international scientific events, further elevating the company's status in research communities in China and globally.
Results from three clinical studies of olverembatinib were selected as abstracts, including one oral presentation, at the 2021 American Society of Hematology (ASH) Annual Meeting. This is the fourth consecutive year in which data of olverembatinib were selected for oral presentation at the ASH Annual Meeting, an indication of the widespread interest in the drug's efficacy and safety from the international hematology community. Results of olverembatinib reported in the oral presentation included the long-term follow-up data (at a median follow-up duration of 39 months) further demonstrated a favorable tolerability, potent and durable efficacy, and clear best-in-class potential in the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant CML. In his presentation at the JPM Conference, Dr. Yang provided a deep dive on the encouraging data from two studies of olverembatinib in patients with T315I-mutant CML.
The clinical data of lisaftoclax, another key candidate of the company's apoptosis-targeted pipeline, were also presented at the 2021 ASH Annual Meeting. These results included the first data readout on lisaftoclax in Chinese patients with hematologic malignances, which demonstrated favorable tolerability and great therapeutic potential, in absence of any tumor lysis syndrome (TLS). The six patients with CLL who received lisaftoclax at 200 mg or higher doses achieved an overall response rate (ORR) of 100% and one complete response. Prior to the ASH Annual Meeting, Ascentage Pharma had released the most updated data from the first-in-human study of lisaftoclax in patients with R/R CLL/SLL and other hematologic malignancies at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, including preliminary data demonstrating an objective response rate (ORR) of 80% and a manageable safety profile, in absence of any TLS despite daily dose ramp-up. All these data collectively further validated lisaftoclax as a drug candidate with global best-in-class potential.
In another oral presentation at the 2021 ASCO Annual Meeting, Ascentage Pharma reported the latest results from the Phase II study of alrizomadlin (APG-115), a MDM2-p53 inhibitor and another key candidate of the company's apoptosis-targeted pipeline, in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have progressed on prior immuno-oncologic drugs. These results provided the clinical evidence supporting the synergy between a MDM2-p53 inhibitor and an immune checkpoint inhibitor, and the first-in-class potential of alrizomadlin.
Furthermore, Dr. Yang highlighted the latest progress in the clinical development of the company's other apoptosis-targeted candidates that had already been reported at multiple international congresses in 2021.
"It is a great pleasure to present at this year's JP Morgan Healthcare Conference, and to provide global healthcare investors with a recap of what we achieved in 2021," said Dajun Yang, Chairman & CEO of Ascentage Pharma. "Ascentage Pharma is steadfastly committed to global innovation and have dedicate tremendous efforts to this vision, with 2021 marking the beginning of a new era of growth and development for the company. Moving forward, we will continue to advance our clinical development programs globally, seek to further solidify our leadership in the development of apoptosis-targeted therapies, and bring more urgently-needed novel therapeutics to patients around the world 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 40 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 China National Medical Products Administration (NMPA), and is already approved for the indication. In addition, the 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 12 ODDs from the US 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 five National Major New Drug Discovery and Manufacturing projects, one New Drug Incubator status, four Innovative Drug Programs, and one 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, MSD, AstraZeneca, and Pfizer. 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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