On March 22, 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 annual results for the full year 2022 (Press release, Ascentage Pharma, MAR 22, 2023, View Source [SID1234629176]). During the reporting period, the company upheld the concept of original innovation and global innovation, and achieved multiple milestones in commercialization, clinical development, and corporate development. The pinnacle of these achievements was the inclusion of olverembatinib (Ascentage Pharma’s first approved product and a drug designated a National Major New Drug Discovery and Manufacturing Program), into the latest National Reimbursement Drug List (NRDL) in January 2023. This inclusion bolstered the drug’s accessibility to patients so significant growth for future sales can be expected.
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In 2022, Ascentage Pharma formally opened the chapter on commercialization, having achieved robust growth in overall performance and strong sales of olverembatinib that underpinned the drug’s enormous potential. During the reporting period, the company’s total revenue grew by 652% from the year before to RMB210 million, most of which was attributable to product sales and commercial partnerships. Since its approval till December 31, 2022, olverembatinib realized an accumulated invoiced sales revenue amount of RMB182 million (audited, inclusive of value-added tax), contributing to the company’s steadily improved cash flow that reached RMB1,500 million in cash and bank balances as of December 31, 2022. In January 2023, Ascentage Pharma successfully completed a follow on offering that increased its total cash balance to RMB1,880 million (as of the reporting day).
The commercialization of olverembatinib boosted by the inclusion into NRDL while making rapid progress with global clinical development programs
As the first and only approved third-generation BCR-ABL inhibitor in China and a drug that was designated a National Major New Drug Discovery and Manufacturing Program, olverembatinib showed its clinical value by fulfilling an urgent clinical gap in patients with T315I-mutant chronic myeloid leukemia (CML) in China. Since its approval till December 31, 2022, olverembatinib generated an accumulated invoiced revenue amount of RMB182 million (audited, inclusive of value-added tax). In January 2023, as a high-profile China-developed innovative drug, olverembatinib was included into the latest NDRL, which is a milestone that drastically improved the drug’s accessibility and affordability to patients.
Ascentage Pharma continuously accelerated the commercialization of olverembatinib. To date, the company has built a commercial team possessing deep expertise in hematology. As a result of the close partnership with Innovent Biologics in commercializing and promoting olverembatinib in the oncology field in China, olverembatinib is now available in 177 direct-to-patient (DTP) pharmacies and over 800 hospitals through 117 distributors across the country. During the same period, olverembatinib was included into the guidelines of the Chinese Society of Clinical Oncology (CSCO) and China Anti-Cancer Association (CACA) to better guide the growing clinical adoption of the drug.
To bring olverembatinib to more patients in need, Ascentage Pharma is accelerating the launch of olverembatinib under a potential full regulatory approval. The Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has accepted and granted Priority Review status to a New Drug Application (NDA) for the full approval of olverembatinib in patients with chronic-phase CML (CML-CP) who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs). The potential approval of this NDA will allow a broader population of patients with CML to benefit from olverembatinib.
Meanwhile, olverembatinib continued to gather widespread interest from the global research community and demonstrate its clinical potential, with results from China studies selected for two oral presentations at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. 2022 was the fifth consecutive year during which clinical results of olverembatinib were selected for oral presentations at the ASH (Free ASH Whitepaper) Annual Meeting, and results presented at the 2022 ASH (Free ASH Whitepaper) Annual Meeting further validated the drug’s long-term efficacy and safety, as well as its therapeutic potential for the treatment of CML. In addition, the company also released the first dataset from a US study of olverembatinib in another oral presentation at the ASH (Free ASH Whitepaper) 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).
Steadfastly committed to global innovation with an industry-leading differentiated pipeline
In 2022, Ascentage Pharma continued to expand its innovative efforts, with the research and development expenses for the year amounted to around RMB740 million. As a result of the company’s expedited global clinical development programs, Ascentage Pharma now has 9 clinical-stage novel small molecule drugs and over 40 Phase I/II clinical studies ongoing in China, the US, Australia, Europe, and Canada. Pursuing its vision for original and global innovation, Ascentage Pharma was awarded 2 Fast-Track Designations, 2 Rare Pediatric Disease Designations, and 16 Orphan Drug Designations from the U.S. Food and Drug Administration (FDA), and 1 Orphan Drug Designation from the European Commission, setting a record in the number of designations granted to any Chinese biopharmaceutical company and is a manifestation of the company’s capabilities in global innovation.
Through its planned and committed effort, Ascentage Pharma has built a large portfolio of global intellectual property rights. As of December 31, 2022, the company holds 235 issued patents and more than 600 patent applications globally, among which 171 patents were issued overseas.
During the reporting period, Ascentage Pharma rapidly advanced its clinical development programs, having built a rich and diverse pipeline targeting hematologic malignancies as well as a promising portfolio in non-hematologic indications. In addition to olverembatinib, the drug that filled an urgent treatment gap in drug-resistant CML, the company also made considerable progress with its Bcl-2 inhibitor lisaftoclax (APG-2575), another key drug candidate in the company’s apoptosis-targeted pipeline. In 2022, there were 19 clinical studies of lisaftoclax ongoing globally, including a pivotal Phase II study in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) that made lisaftoclax the first Bcl-2 inhibitor with clear clinical activity to have entered a pivotal study in China and the second anywhere globally. Moreover, following the recent IND approvals for lisaftoclax in China, the drug is poised to enter a number of combination studies including one evaluating lisaftoclax in combination with the MDM2-p53 inhibitor alrizomadlin (APG-115), another lead asset in the company’s apoptosis-targeted pipeline.
Another one of Ascentage Pharma’s high-potential assets, the first China-developed novel inhibitor of the embryonic ectoderm development (EED) protein APG-5918, also entered clinical development in 2022. The drug 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.
Elevated leadership in chosen areas with key assets garnering growing interest from the global research community
As an industry leader focused on original innovation and the development of novel drugs targeting the apoptotic pathway, Ascentage Pharma has frequently presented results from multiple clinical programs that received widespread interest at major international congresses. This is a testament to the company’s robust capabilities in oncologic research and clinical development, as well as the first-in-class and best-in-class potential of its key assets.
Lisaftoclax is the first Bcl-2 selective inhibitor with clear clinical activity to have entered a pivotal study in China and the second globally. Results announced in an oral presentation at the 2022 ASH (Free ASH Whitepaper) 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 objective response rate (ORR) of 98% in combination with a Bruton’s tyrosine kinase inhibitor (BTKi). In addition, results from a study of lisaftoclax in Chinese patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) were released at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting. These results showed an ORR of 87.5% which once again validated the drug’s global best-in-class potential.
Furthermore, the clinical results of the company’s other investigational assets, including the MDM2-p53 inhibitor, alrizomadlin; FAK/ALK/ROS1 TKI, APG-2449; IAP antagonist, APG-1387; and Bcl-2/Bcl-xL inhibitor, APG-1252, were released at prominent international congresses and in renowned scientific journals, winning the company broad recognition for its innovation and clinical development capabilities.
Accelerated transformation into an innovative biopharma with expanding presence in global markets
In 2022, Ascentage Pharma achieved many important milestones, having obtained a Drug Manufacturing License (Certificate A) that allowed it to commence operations at its Global Manufacturing Center where the company will implement stringent quality management in compliant with the cGMP standards of China and western markets. This will enable the company to produce proprietary medicines with global intellectual property rights for the global markets and propel Ascentage Pharma further into the transition towards a global innovative biopharma with vertically integrated capabilities covering the entire ecosystem.
In January 2023, Ascentage Pharma successfully raised HKD550 million through the follow on placement, which proved the investors’ strong recognition for the company’s value. Recently, the Shanghai Stock Exchange selected Ascentage Pharma for the initial inclusion in the Shanghai-Hong Kong Stock Connect Program, officially effective as of March 13, 2013. Following this adjustment, Ascentage Pharma is now a company included in both Shenzhen-Hong Kong and Shanghai-Hong Kong Stock Connect Programs. This could potentially lead to increased trading volume and improved liquidity for the company’s stocks.
"2022 was indeed an extraordinary year for Ascentage Pharma as we delivered multiple milestones, among which, the inclusion of olverembatinib into the 2022 NRDL was vital for bolstering the drug’s accessibility and affordability for patients. Thus far, olverembatinib has already delivered strong sales and further boosted our confidence in the product. Furthermore, the China CDE has accepted and granted Priority Review designation for an NDA supporting a full approval of olverembatinib, which paved the way for a potential new treatment option for the broad population of patients with CML," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "The impressive success of olverembatinib highlights our commitment to fulfilling the mission of addressing unmet clinical needs in China and around the world, and our patient-focused global innovation strategy. In the past year, we released results from several clinical programs at some of the most renowned international congresses, wining us widespread recognition for our robust global innovation capabilities."
Dr. Yang continued, "Also in the past year, we were granted a Drug Manufacturing License (Certificate A) that allowed us to commence operations at our Global Manufacturing Center, another big step in our transition from a biotech to a biopharma. Meanwhile, we successfully raised HKD550 million in early 2023, giving the company a stronger balance sheet that will better support our operations."
In conclusion, Dr. Yang said, "moving forward, we will continue to expand the reimbursement coverage for olverembatinib, further improve the drug’s accessibility, and explore the drug’s additional therapeutic potential for the benefit of more patients. To deepen the implementation of our global innovation strategy, we will forge ahead with the global clinical development of our key assets such as lisaftoclax to address urgent unmet medical needs in China and around the world. Building on our past success, we will strive to bring more novel therapeutics to patients and create greater value for our shareholders."