On August 21, 2023 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported its 2023 interim results (Press release, Ascentage Pharma, AUG 21, 2023, View Source [SID1234634606]). During the reporting period, Ascentage Pharma remained steadfastly committed to its strategy of original innovation and global innovation, having achieved multiple milestones in key aspects of its business including commercialization and global clinical development.
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During the reporting period, Ascentage Pharma’s revenue substantially increased by 49% from the same period last year to RMB143 million, with most of the revenue generated through product sales and commercial partnerships. The sales of the company’s first approved product, olverembatinib (HQP1351), for the first half of this year, has substantially increased by 37% from the same period last year to RMB108 million, following the inclusion into the 2022 China National Reimbursement Drug List (NRDL) in January 2023. Also in January 2023, Ascentage Pharma successfully raised HK$550 million from an equity placing that helped strengthen the overall health of the company’s cashflow. As of June 30, 2023, the company’s cash balances were RMB1,580 million.
Validating the global best-in-class potential of olverembatinib while boosting the drug’s sales and exploring its therapeutic potential in additional indications
Olverembatinib, a novel drug developed by Ascentage Pharma, is the first and only China-approved third-generation BCL-ABL inhibitor that has effectively filled the treatment gap in patients with T315I-mutant chronic myeloid leukemia (CML). Since receiving the approval for olverembatinib, Ascentage Pharma stepped up its effort to commercialize the drug and has since achieved a number of milestones. In January 2023, as a novel therapeutic supported by the National Major New Drug Discovery and Manufacturing Program, olverembatinib was included into the newly updated NDRL in China, thus greatly improving the drug’s accessibility and affordability in the country. Olverembatinib recorded a total sales revenue of RMB108 million during the reporting period, representing an increase of 37% from the same period last year. Particularly in the second quarter of 2023, olverembatinib recorded a year-on-year growth of 153% in revenue and 560% in volume, a clear result of the booster effect from the NRDL inclusion. Furthermore, the company expects to receive the marketing authorization for olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase CML (CML-CP) in the near future. Once approved, a broader population of patients with CML will be able to benefit from olverembatinib.
Beside CML, olverembatinib is being evaluated in a range of additional indications. During the reporting period, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved a registrational Phase III study designed to evaluate olverembatinib plus chemotherapy versus imatinib plus chemotherapy in patients with treatment-naïve Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This approval marks another important milestone in the development of olverembatinib as it could potentially pave the way for the drug to become the first TKI approved for the first-line treatment of patients with Ph+ ALL in China. At the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress, poster presentations featuring the latest results from two clinical study of olverembatinib for the treatment of patients with Ph+ ALL showed promising efficacy and favorable safety. Meanwhile, the clinical data of olverembatinib in pediatric patients with Ph+ ALL were published in a renowned international scientific journal for the first time. These results demonstrated favorable efficacy and safety olverembatinib in the studied patients.
In addition to its broad portfolio in hematologic malignancies, Ascentage Pharma is also actively advancing the clinical development of olverembatinib in gastrointestinal stromal tumor (GIST). During the reporting period, olverembatinib was granted a Breakthrough Therapy Designation (BTD) by the China CDE for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment. During the same period, the clinical results of olverembatinib in patients with GIST was selected for presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the second consecutive year. Results presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting showed impressive efficacy and manageable safety, including a clinical benefit rate (BCR) of 93.8%, in patients with TKI-resistant SDH-deficient GIST.
Building a solid moat around hematologic malignancies as core drug candidate gets cleared to enter a global registrational Phase III trial
While olverembatinib, the company’s first approved product, begins to generate growing cash flow for the company, Ascentage Pharma is deepening its pipeline development in hematologic malignancies to build a robust moat around the therapeutic area. During the reporting period, another one of the company’s core drug candidates, the Bcl-2 inhibitor lisaftoclax (APG-2575), was cleared by the US Food and Drug Administration (FDA) to enter a global registrational Phase III study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marking another major milestone in the global clinical development of lisaftoclax.
In the backdrop of NDA approval and NRDL inclusion of olverembatinib in China, this milestone in the development of lisaftoclax underscores the drug’s emergence as a strong contender in the global market capitalizing on the drug’s global best-in-class potential, and highlights Ascentage Pharma’s formidable competitive edge in the hematology field and excellence in global innovation.
In the first half of 2023, Ascentage Pharma released the first batch of preliminary data from the Phase Ib/II study of lisaftoclax as a monotherapy or combined with ibrutinib or rituximab in patients with Waldenström macroglobulinemia at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. These results showed an impressive overall response rate (ORR) of 100%, as well as favorable tolerability and manageable safety of lisaftoclax combined with ibrutinib in treatment-naïve patients with WM, thus further validating the drug’s therapeutic potential in hematologic malignancies.
Deepening global innovations with rising global status
As an innovative biopharmaceutical company anchored around original and global innovation, Ascentage Pharma has built a competitive pipeline of innovative assets with first-in-class and best-in-class potentials and is currently conducting more than 40 clinical studies in China, the United States, Australia, Europe, and Canada. To date, Ascentage Pharma has obtained a total of 16 Orphan Drug Designations (ODDs), two Fast-Track Designations (FTDs), and one Rare Pediatric Disease Designation from the US FDA, as well as one Orphan Designation from the EMA of the EU, for four of the company’s investigational drug candidates, setting a record for any Chinese pharmaceutical company. Meanwhile, the company has further strengthened its intellectual property portfolio. As of June 30, 2023, Ascentage Pharma holds 468 issued patents globally, among of which 336 patents were issued overseas.
Yielding from the company’s global innovation strategy, several Ascentage Pharma’s core assets are showing first-in-class and best-in-class potentials in clinical development and their clinical results have been selected by a series of major international medical congresses, an indication of the global research community’s growing recognition of Ascentage Pharma’s robust capabilities in innovation and clinical development.
For six consecutive years, Ascentage Pharma has presented clinical results at the ASCO (Free ASCO Whitepaper) Annual Meeting. In 2023, the company presented results from four clinical studies of olverembatinib, lisaftoclax, the MDM-p53 inhibitor alrizomadlin, and the FAK/ALK/ROS1 inhibitor APG-2449. In addition to olverembatinib and lisaftoclax, the data of alrizomadlin were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting for the third consecutive year. In 2023, the announced results of alrizomadlin further demonstrated the drug’s clinical potential in patients with cutaneous melanoma that had failed immuno-oncology (IO) drugs. Furthermore, results of APG-2449 were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting for the second consecutive year in 2023, revealing the drug’s potential therapeutic value for the treatment of advanced non-small cell lung cancer (NSCLC).
Additionally, results from three preclinical studies of olverembatinib, lisaftoclax, and alrizomadlin were released at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and provided strong rationale for the future clinical investigation of those drug candidates.
Steadily evolving into an innovative global biopharmaceutical company with solidifying leadership position
During the reporting period, Ascentage Pharma continued to make major strides in its transition towards an innovative global biopharmaceutical company. After obtaining the Drug Manufacturing License (Certificate A) in 2022, Ascentage Pharma received a zero-deficiency report from the Good Manufacturing Practice (GMP) compliance audit by a Qualified Person (QP) of the European Union (EU) in April 2023, which indicates that the company’s Global Manufacturing Center and its quality management system are now fully compliant with the GMP standards of the EU. This is a big step in Ascentage Pharma’s global expansion as it will propel the company further into its transition into an enterprise with vertically integrated capabilities spanning the entire value chain.
In capital markets, Ascentage Pharma continued to garner broad interest and support. In January 2023, the company successfully raised approximately HK$550 million through a placing of additional shares that signified investors’ recognition of the company’s value for investment. On March 13, 2023, Ascentage Pharma was selected by the Shanghai Stock Exchange for the first group of new additions to the Shanghai-Hong Kong Stock Connect program, thereby making Ascentage Pharma a company included in both Shenzhen-Hong Kong and Shanghai-Hong Kong Stock Connect programs. This inclusion further improves the liquidity and trading volume of the company’s stocks.
Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, "In the first half of 2023, Ascentage Pharma achieved multiple milestones and showcased its innovative prowess as our global innovation strategy continues to deliver results. The most encouraging one of those achievements is the inclusion of olverembatinib, a frontrunner among drugs supported by the National Major New Drug Discovery and Manufacturing Program, into the 2022 China NRDL and the significant increase in product sales that followed the inclusion. The steady growth of olverembatinib provides an important cornerstone to our commercialization efforts and another booster to our confidence. During the reporting period, olverembatinib was granted a clinical trial approval by the CDE, in a move that could potentially pave the way for the drug to become the world’s first TKI approved for the first-line treatment of Ph+ ALL and allow the drug to benefit a broader population of patients.
While expeditiously advancing our commercialization programs, we have made important progress in global clinical development. As the first Bcl-2 inhibitor that has showed clear efficacy and entered pivotal registrational studies in China and the second anywhere globally, our core drug candidate lisaftoclax was cleared by the US FDA to enter a global pivotal registrational Phase III study, taking another big step forward in the drug’s accelerating global clinical development. This achievement highlights Ascentage Pharma’s strength in hematology and our efforts to lead the way for fellow Chinese companies that are aspiring to expand their clinical development to the global arena.
As a company focused on original and global innovation, we have presented research results and clinical data of multiple drug candidates at major international scientific congresses, wining broad recognition of our robust research and clinical development capabilities. We will continue to evaluate olverembatinib in additional indications and forge ahead with its global clinical development to allow patients worldwide to benefit from the drug as soon as possible. Meanwhile, we will accelerate the global clinical development of other investigational assets, including lisaftoclax, to fulfill our mission of addressing unmet clinical needs in China and around the world, bring hope to more patients, and create additional value for our investors."