On March 29, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported its annual results for the year ended December 31, 2019 (Press release, Ascentage Pharma, MAR 29, 2020, View Source [SID1234555966]). During the reported period, Ascentage Pharma further increased its investments in innovation, and achieved significant progress in clinical development, external collaborations, intellectual property rights, and the building of its manufacturing capabilities. In 2020, Ascentage Pharma plans to submit its first New Drug Application (NDA).
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Achieving significant progress with drug candidates while advancing global clinical development
As of December 31, 2019, Ascentage Pharma has developed a robust pipeline of eight clinical-stage small molecule drug candidates, currently being evaluated in more than 30 Phase I or II clinical trials in the United States, Australia, and China. The Company’s pipeline consists of inhibitors that target key proteins in the apoptotic pathways, including the Bcl-2, IAP, and MDM2-p53 pathways, to restore normal apoptotic functions; and next-generation tyrosine kinase inhibitors (TKIs) that target mutant kinases in cancers.
With increased investments in innovation, the Company’s research and development expenses for the year ended December 31, 2019, totaled RMB464 million. During the reported period, Ascentage Pharma achieved significant progress with the global clinical development of its drug candidates.
HQP1351, Ascentage Pharma’s core drug candidate and a third-generation BCR-ABL/KIT inhibitor, has achieved several milestones during the reported period. As of December 31, 2019, the Company had completed enrollments for two pivotal Phase II clinical trials of HQP1351 in patients with chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML) in China, and had initiated a third pivotal Phase II trial in CML patients resistant/intolerant to first and second-generation TKIs in China. Meanwhile, the development program of HQP1351 in the United States is also progressing well, with the Phase Ib trial having been initiated in July 2019 and the first patient dosed in January 2020. It is worth noting that results from the Phase I clinical trial of HQP1351 were selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings two years in a row, and was nominated as "Best of ASH (Free ASH Whitepaper)" research in 2019. Ascentage Pharma plans to submit an NDA for HQP1351 in China in 2020 and expects HQP1351 to become the Company’s first commercialized product.
APG-2575, a key drug candidate in the Company’s pipeline targeting apoptosis, is a novel, orally administered Bcl-2 selective inhibitor that has also met numerous milestones with its global clinical programs during the reported period. In July 2019, APG-2575 dosed the first patient in the Phase I trial in China, and became the first China-developed Bcl-2 selective inhibitor entering clinical stage. Previously, the Company had already initiated a multi-center Phase I study of APG-2575 as a monotherapy for the treatment of hematologic malignancies in the United States and Australia. In March 2020, the Company obtained approvals from the U.S. Food and Drug Administration (FDA) for two global Phase Ib/II clinical trials of APG-2575, as a single agent and in combination with other agents, one study in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and another one in patients with Waldenström macroglobulinemia (WM). The Phase Ib/II study in patients with relapsed/refractory CLL/SLL has recently dosed its first patient in the United States. Upon receiving the recent approval from the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), Ascentage Pharma will soon initiate a Phase Ib study of APG-2575 as a single agent or in combination for the treatment of relapsed/refractory acute myeloid leukemia (AML) in China.
In addition, the Company has further advanced the development of several other drug candidates, including APG-1252, a novel Bcl-2/Bcl-xL dual inhibitor; APG-115, a MDM2-p53 inhibitor; and APG-1387, an IAP inhibitor.
Building a global IP portfolio and expanding strategic partnerships to accelerate transition toward commercialization
Intellectual property rights are of vital importance to Ascentage Pharma, a China-based innovative biopharmaceutical company with a global footprint. Utilizing its robust R&D capabilities, Ascentage Pharma has strategically developed a global intellectual property portfolio. As of December 31, 2019, the Company has 80 issued patents and more than 200 patent applications globally, of which about 67 patents had been issued overseas.
While building a highly capable R&D team, Ascentage Pharma has cultivated partnerships with leading biotechnology and pharmaceutical companies, and academic institutions around the world. In April 2019, Ascentage Pharma entered into a clinical collaboration agreement with Junshi Biosciences to explore the synergies of the IAP inhibitor, APG-1387, and Junshi Biosciences’ anti-PD-1 therapy, toripalimab, in clinical trials in solid and hematologic tumors in China. The clinical study has already been approved and initiated in China. In November 2019, the Company entered into a strategic collaboration with Shanghai Henlius Biotech, to conduct clinical trials of combination therapy between APG-2575, Ascentage Pharma’s novel, orally administered Bcl-2 selective inhibitor and 汉利康 (rituximab injection) for the treatment of CLL in China.
In the meantime, Ascentage Pharma has begun executing its industrialization strategies. In November 2019, Ascentage Pharma broke ground on its global headquarters, R&D center, and manufacturing facility in the Suzhou Industrial Park. At the new facility, which has a planned building area of approximately 10,000m2, the Company plans to produce drug products for clinical development or, in the future, commercial use. Ascentage Pharma expects this facility to consist of two oral-solid-dosage production lines, for both tablet and capsule formulations, and two parenteral liquid/lyophilization powder-for-injection production lines.
"2019 marked some major milestones for Ascentage Pharma, as we pressed ahead with the implementation of our innovation strategies globally. In the past year, we made tremendous headways with our drug candidates, including HQP1351, a core drug candidate in our pipeline, advanced several global clinical programs, which further elevated Ascentage Pharma’s influence in the global medical and scientific community. We continued to increase investments in R&D, which strengthened our innovation capabilities. Our effort to expand external collaborations led to the partnerships with Unity, Junshi Biosciences, and Shanghai Henlius Biotech. By commencing the construction of the Company’s global headquarters, R&D center, and manufacturing facility in Suzhou, Ascentage Pharma has begun its transition toward manufacturing," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Moving forward, we will continue to boost our R&D capabilities, accelerate clinical development programs, and prepare ourselves for the first NDA submission and product commercialization, in fulfilling our mission of ‘addressing unmet clinical needs in China and around the world’."