Ascentage Pharma (6855.HK) today announced that Dr. Dajun Yang, the company’s Chairman and CEO, has delivered a presentation at the 41st Annual J.P. Morgan Healthcare Conference showcasing the progress Ascentage Pharma has made with its global innovation strategies and rapid transition from a biotech to a full-fledged biopharmaceutical company.
Accelerated Commercialization of Its First Approved Product, Olverembatinib, While Continued to Validate the Drug’s Clinical Potential Globally
Ever since olverembatinib was approved in China in November 2021, Ascentage Pharma pressed ahead with the commercialization of the drug and achieved remarkable results in just a year after the approval. As of June 30, 2022, Ascentage Pharma’s total cash balance was RMB 1,700 million, and recorded a total sales revenue of RMB 95.76 million, which represents a growth of 636.9% in sales revenue from the same period last year. In particular, since olverembatinib was approved until June 2022, the drug recorded a total sales revenue of RMB 95.93 million (unaudited and inclusive of value added tax).
As the first and only China-approved drug for the treatment of T315I mutant chronic myeloid leukemia (CML), olverembatinib fills an urgent treatment gap in China and promises great clinical potential that could change the treatment paradigm for patients with CML globally.
The New Drug Application (NDA) for olverembatinib for the treatment of patients with chronic-phase CML (CML-CP) who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs) was accepted and granted Priority Review designation by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). The potential approval of this NDA could bring this novel treatment option to a broader population of patients with CML in China. Moreover, the company has initiated a named patient program (NPP) to allow select patients the early access to olverembatinib in over 130 countries and regions where the drug is not yet commercially available and to pave the way for its future launch in global markets.
In the past year, olverembatinib continued to gather interest from the global research community and demonstrate its clinical utility. Results from the two China studies of olverembatinib were selected for Oral Presentations at the 2022 American Hematology Society (ASH) Annual Meeting, which showed the drug’s long-term efficacy and safety profile, and strong overall potential for the treatment of CML. 2022 marked the fifth consecutive year in which clinical results of the drug were announced in Oral Presentations at the ASH Annual Meeting. In addition, the company also released the first dataset from a US study of olverembatinib in another Oral Presentation at the ASH Annual Meeting. These data show that olverembatinib can potentially overcome the drug resistance to ponatinib and has promising activity in patients with refractory CML and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Furthermore, results from a preclinical study of olverembatinib was published in the renowned scientific journal EMBO Molecular Medicine, showing olverembatinib’s therapeutic potential for the treatment of COVID-19 infections. Multiple studies have validated the drug’s global best-in-class potential and Ascentage Pharma’s growing innovative prowess.
A Leader in Drug Innovation Developing Multiple Highly-Differentiated Assets
Remaining focused on original innovation and global R&D, Ascentage Pharma has built a pipeline of nine clinical-stage novel drug candidates and initiated over 50 Phase I/II clinical studies across China, the United States, Australia, Europe and Canada, and is forging ahead with these global clinical programs. All of its drug candidates have first-in-class or best-in-class potential, and are being validated in a broad range of clinical programs.
In hematologic malignancies, Ascentage Pharma has a particularly robust portfolio. In addition to olverembatinib, the drug that filled the treatment gap in TKI-resistant CML with the T315I mutation in China, the company is also making steady progress with the clinical development of its investigational Bcl-2 inhibitor lisaftoclax. A total of 19 clinical studies of lisaftoclax are currently ongoing globally with the first patient already dosed in the pivotal Phase II study in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL), making lisaftoclax the first Bcl-2 inhibitor with clear clinical activity to have entered a pivotal study in China and the second anywhere globally. Results announced in an Oral Presentation at the 2022 ASH Annual Meeting showed the strong clinical potential of lisaftoclax, either as a monotherapy or in combinations, in the treatment of R/R CLL/SLL, demonstrating an impressive objective response rate (ORR) of 98% in combination with a Bruton’s tyrosine kinase (BTK) inhibitor. These results once again signaled the strong best-in-class potential of lisaftoclax.
Another one of Ascentage Pharma’s high-potential assets, the novel inhibitor of the embryonic ectoderm development (EED) protein APG-5918, also entered clinical development in 2022. This first China-developed EED inhibitor in clinical development is currently being evaluated in clinical studies in advanced solid tumors and hematologic malignancies in both China and the US, an achievement of Ascentage Pharma’s effort to simultaneously advance a clinical program in the two countries. Meanwhile, APG-5918 will soon enter its first clinical study in non-oncologic diseases, with the IND for anemia diseases already approved by the CDE in China.
During the presentation, Dr. Dajun Yang shed additional light on the company’s other clinical and preclinical assets, including the MDM2-p53 inhibitor alrizomadlin, the IAP antagonist APG-1387, and the Bcl-2/Bcl-xL inhibitor APG-1252. The data of these drug candidates, already released at numerous international congresses and scientific journals, collectively further demonstrate Ascentage Pharma’s robust capabilities in drug innovation and clinical development.
Fast Emerging as a Global Biopharmaceutical Leader from China
In 2022, Ascentage Pharma achieved multiple important milestones in corporate development, having obtained the Drug Manufacturing License (Class-A License) that allowed it to commence operations at its Global Manufacturing Center where the company will implement stringent quality management compliant with the cGMP standards of China and major international markets. This will enable the company to produce proprietary medicines with global intellectual property rights for the global market and propel Ascentage Pharma further into the transition towards a global innovative biopharmaceutical with vertically integrated capabilities covering the entire ecosystem.
Leveraging the synergistic effect generated by the R&D center at the company’s global HQ and its Global Manufacturing Center, Ascentage Pharma launched the Ascentage Innovation Hub, to attract startups and support them as an accelerator and incubator. Through this initiative powered by both Ascentage Pharma and its angel investment fund, the company aims to help build a competitive ecosystem that can foster the development of highly innovative and differentiated novel medicines.
“It is my great pleasure to attend this year’s Annual J.P. Morgan Healthcare Conference and have the opportunity to update global investors on what we have achieved in 2022 and showcase the vibrant drug innovation in China. In the past year, the China-developed novel drug olverembatinib received tremendous interest from the international hematology community, with strong recognition for our original innovation and global R&D. Meanwhile, we are very proud of the big strides we have made in our transition from a biotech to a full-fledged biopharma,” said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma.
“Moving forward, we will continue to deepen our drug innovation and accelerate our global clinical programs to fulfill our founding mission of addressing unmet clinical needs in China and around the world for the benefit of more patients and to bring more China-developed novel drugs to the global stage.”