During the reporting period, Ascentage Pharma achieved steady improvement to its cash flow. As of June 30, 2022, the company's cash and bank balances were RMB1,698 million, which remained relatively constant when compared with the cash and bank balances as of December 31, 2021. Meanwhile, the company's revenue for the six months ended June 30, 2022 substantially increased by 636.9%, from the same period last year, to RMB95.76 million. This increase in revenue was mainly attributable to the sales of olverembatinib, commercialization license fee income of patented IP and service income from customers. It is worth noting that since its approval in last November till the end of June 2022, olverembatinib has already realized an accumulated invoiced sales revenue amount of RMB95.93 million (unaudited, inclusive of value added tax).
Accelerated the commercialization of olverembatinib while continued to explore the drug's therapeutic potential
Olverembatinib, the first and only drug approved for the treatment of chronic myeloid leukemia (CML) harboring the T315I mutation in China and Ascentage Pharma's core asset that was designated a National Major New Drug Development and Manufacturing Program, effectively ended of the lack of treatment options for patients with CML harboring the T315I mutation, therefore has enormous clinical value. Since being approved till the end of June 2022, olverembatinib has realized an accumulated invoiced sales revenue amount of RMB95.93 million (unaudited, inclusive of value added tax).
To date, Ascentage Pharma has built a commercial organization possessing a wealth of experience in hematology and entered into a strategic collaboration with Innovent Biologics to jointly commercialize olverembatinib in China. In the months since its approval till June 2022, olverembatinib has been included by 34 government-backed local supplementary insurance programs in 10 provinces, substantially expanding the drug's accessibility to patients. Meanwhile, olverembatinib was included into the Chinese Society of Clinical Oncology (CSCO) Guidelines and the China Anti-Cancer Association's (CACA) 2022 Guidelines for the Holistic Integrative Management of Cancers, thus provided clinicians the necessary guidance in their practices. As a China-developed novel drug with clear global best-in-class potentials, olverembatinib is bringing clinical benefits to a growing number of patients around the world.
In partnership with Tanner Pharma, a global pharmaceutical services provider of specialty access solutions, Ascentage Pharma launched an innovative Named Patient Program (NPP) similar to the early access programs seen in the city of Boao in Hainan province, to allow Tanner to supply olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available. The NPP plans to cover more than 130 countries and regions around the world.
In July 2022, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) accepted and granted Priority Review designation to a New Drug Application (NDA) that will support the full approval of olverembatinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs). Following the conditional approval for olverembatinib in 2021, this marks another milestone development that would expedite olverembatinib's journey to a broader population of patients with CML in China.
Currently, Ascentage Pharma is actively advancing the clinical development of olverembatinib globally. During the reporting period, olverembatinib was cleared by Health Canada to enter a Phase Ib study in patients with refractory CML or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), making it Ascentage Pharma's first clinical study in Canada. Prior to this, olverembatinib had already been cleared to enter clinical trials in the US.
In addition to hematologic indications, the company is also exploring olverembatinib's clinical utility in other therapeutic areas. At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Ascentage Pharma released the first dataset of olverembatinib in patients with gastrointestinal stromal tumor (GIST). These results showed promising antitumor activity in patients with TKI-resistant succinate dehydrogenase- (SDH-) deficient GIST with a clinical benefit rate (CBR) of 83.3%.
Furthermore, a new preclinical study discovered olverembatinib's therapeutic potential as an alternative treatment for patients with moderate to severe COVID-19 infections. These preclinical data have already been published by the EMBO Molecular Medicine, a renowned scientific journal affiliated to the European Molecular Biology Organization (EMBO).
These studies demonstrated olverembatinib's therapeutic potential and differentiated clinical utility in a wide range of therapeutic areas. With expected further expansion of its indications, olverembatinib will benefit a broad patient population globally.
Executing the strategy of global innovation as a pioneer for the industry
In the first half of 2022, Ascentage Pharma continued to increase its investment in innovation, with the research and development expenses increased by 7.5% year on year, to RMB341 million. Pressing ahead with its global clinical development programs, nine of Ascentage Pharma's candidate drugs have already entered the clinical stage, currently being evaluated in more than 50 Phase I/II clinical studies in China, the US, and Australia. Meanwhile, Ascentage Pharma has further strengthened its intellectual property portfolio, paving the way for its accelerating research and development. As of June 30, 2022, the company holds 205 issued patents and more than 600 patent applications globally, among of which, 148 patents were issued overseas.
During the reporting period, Ascentage Pharma made rapid progress with its momentous clinical development programs covering an array of therapeutic areas. In addition to the company's apoptosis-targeting assets and kinase inhibitors, Ascentage Pharma has also made strides with the development of candidate drugs targeting other novel targets, including its embryonic ectoderm development (EED) protein inhibitor that has attracted widespread interest from the research community. The EED inhibitor, APG-5918, was cleared by the US Food and Drug Administration (FDA) to enter a first-in-human study evaluating the safety, pharmacokinetics, and efficacy of APG-5918 in patients with advanced solid tumors and hematologic malignancies, and the IND for APG-5918 has already been accepted by the CDE in China. As the first China-developed EED inhibitor entering clinical development, APG-5918 underlines Ascentage Pharma's capabilities in discovering and developing first-in-class/best-in-class novel assets.
While making strides with its global innovation, Ascentage Pharma was granted two Fast-Track designations and two Rare Pediatric Disease designations by the US FDA, and a total of 16 Orphan Drug designations by the US FDA and the EMA of the EU, a record number for any Chinese biopharmaceutical company.
Multiple highly differentiated clinical programs are steadily approaching fruition
As a global leader in the development of apoptosis-targeted drugs, Ascentage Pharma has presented the clinical data of its investigational assets at multiple international scientific congresses showcasing the first-in-class and best-in-class potential of these assets.
A Phase II pivotal study of lisaftoclax (APG-2575), the first China-developed Bcl-2 selective inhibitor entering clinical development and a key member of the company's apoptosis-targeted pipeline, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) was approved by the CDE at the end of 2021 and dosed its first patients in March 2022, making lisaftoclax the second Bcl-2 selective inhibitor entering pivotal trials globally. To date, lisaftoclax is being investigated in a total of 19 studies globally for the treatment of multiple hematologic malignancies and solid tumors, and has shown promising therapeutic potentials.
During the reporting period, Ascentage Pharma announced the updated data of lisaftoclax in Chinese patients with R/R CLL/SLL at the 2022 ASCO Annual Meeting. These data showed an objective response rate (ORR) of 67.4% and favorable tolerability. In terms of safety, most adverse events were manageable, no dose-limiting toxicity (DLT) was observed at the maximum dose of 800mg, and the risk of clinical tumor lysis syndrome (TLS) in patients on daily dose ramp-up was minimal.
Furthermore, Phase I data of lisaftoclax in Chinese patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) were released at the 2022 European Hematology Association (EHA) Hybrid Congress. These data showed, lisaftoclax was well tolerated at doses of up to 800 mg/day, without evidence of TLS, and has antitumor activity in a range of relapsed/refractory hematologic malignancies such as CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and T-cell NHL. In the 11 efficacy evaluable patients with CLL (all of whom were heavily pretreated and had failed prior therapies such as chemoimmunotherapies and Bruton's tyrosine kinase [BTK] inhibitors, and the majority had at least one type of adverse prognostic factors such as 17p deletion/TP53 mutation), there were 8 efficacy evaluable patients in cohorts received 200 mg or higher doses, including 3 complete responses (CRs) and 4 partial responses (PRs), thus demonstrating an ORR of 87.5%. There is a growing body of evidence signifying the global best-in-class potential of lisaftoclax.
While at the 2022 ASCO Annual Meeting, Ascentage Pharma reported the updated clinical data of alrizomadlin (APG-115), a MDM2-p53 inhibitor that is also a key asset in the company's apoptosis-targeted pipeline, in combination with pembrolizumab. These data validated the antitumor efficacy of the combination therapy in patients with immuno-oncologic- (I-O) drug-resistant or recurrent melanoma, including two CRs, an ORR of 11% and a disease control rate (DCR) of 57%. The study also observed promising clinical benefit to patients with malignant peripheral nerve sheath tumor (MPNST), demonstrated by a DCR of 50%. MPNST is a rare pediatric type of sarcoma lacking effective treatment options. These results provide additional evidence validating the synergy and the first-in-class potential of MDM2-p53 inhibitors plus immuno-oncologic drugs.
Also at the 2022 ASCO Annual Meeting, Ascentage Pharma released the first dataset from the Phase I study of the company's novel FAK inhibitor and third-generation ALK/ROS1 TKI, APG-2449, in patients with second-generation TKI-resistant ALK/ROS1+ non-small-cell lung cancer (NSCLC) or mesothelioma. According to these results, 4 of the 14 ALK+ patients resistant to second-generation TKIs achieved PRs, 10 TKI-naïve patients achieved an ORR of 80%, at a DCR of 100%. APG-2449 is the first China-developed third-generation ALK inhibitor. The candidate drug's clinical progress is a manifestation of Ascentage Pharma's R&D capabilities in the field of solid tumors.
Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, "In the first half of 2022, Ascentage Pharma made solid progress in both commercialization and clinical development, successfully navigated the challenging circumstances posted by the COVID-19 pandemic. The rapid and successful commercialization of olverembatinib, the first and only third-generation BCR-ABL inhibitor, in the months after the NDA approval, has led to substantial revenue growth, allowing us to maintain a healthy cash flow that is essential to the company's long-term development.
While forging ahead with the commercialization of olverembatinib in China, we launched a global NPP to offer patient access to olverembatinib in areas where the drug is not yet commercially available, in efforts to meet the unmet medical needs of patients from around the world. The NPP highlights olverembatinib's differentiated clinical value and serves as a very important prelude to the drug's future global launch. To our surprise, we discovered olverembatinib's therapeutic potential as an alternative treatment for COVID-19 infections, and we plan to further evaluate the drug in clinical settings.
Executing on our strategy of global innovation, we presented the latest research data and clinical results of lead assets including olverembatinib, lisaftoclax, alrizomadlin, and APG-2449, at multiple international congresses such as the ASCO, EHA, and AACR annual meetings. These data readouts are indicative of our rich portfolio and promising clinical programs that are steadily approaching the point of fruition.
As a company focused on original pharmaceutical innovation, we will continue to expand the accessibility, advance the indication expansion and global clinical development of olverembatinib, while pressing ahead with the development programs of other investigational assets. We will remain steadfastly committed to global innovation and the mission of addressing unmet clinical needs in China and around the world, to create additional value for our investors and bring much needed novel therapies to our patients 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 nine 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 50 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 the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, 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 15 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) designations from the 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 5 National Major New Drug Discovery and Manufacturing projects, 1 New Drug Incubator status, 4 Innovative Drug Programs, and 1 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, Merck, AstraZeneca, and Pfizer. The company has built a talented team with global experience in discovering, developing, launching, and commercializing innovative drugs and is setting up 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.
Forward-Looking Statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.
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