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.
