SUZHOU, China, and ROCKVILLE, Md., Nov. 24, 2023 /PRNewswire/ — 23 Nov, 2023, on the second anniversary of the initial approval for olverembatinib, Ascentage Pharma hosted a ceremony in Suzhou, China, marking the launch of olverembatinib in a newly approved indication and the dispatch of the first batch of the drug for the new indication.
On November 17, 2023, the China National Medical Products Administration (NMPA) approved olverembatinib (HQP1351) for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). This approval, marking yet another major milestone for olverembatinib following its first regulatory approval in 2021 and the subsequent inclusion into the China 2022 National Reimbursement Drug List (NRDL), which will benefit a broader population of patients with CML in China.
This approval for olverembatinib is based on the results from an open-label, national multicenter, randomized-controlled, registrational pivotal Phase II study (HQP1351CC203) that evaluated the efficacy and safety of olverembatinib in patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs. Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT). Results from the study show that compared to patients who were treated with the BAT in the control group, those received olverembatinib achieved statistically significant improvement in the primary endpoint of event-free survival (EFS), meeting the primary endpoint of the study. In March 2021, the Center of Drug Evaluation (CDE) of the NMPA granted olverembatinib a Breakthrough Therapy Designation (BTD) to olverembatinib; and in July 2022, the New Drug Application (NDA) for olverembatinib in this indication was accepted and granted a Priority Review Designation by the CDE.
CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs has significantly improved the management of CML. However, 20%-40% of patients fail to achieve desired treatment outcome due to resistance or intolerance to TKIs[1]-[3], thus leading to disease progression or even death. At present, resistance to TKIs is posing a major challenge to the management of CML globally and patients are in desperate need of a new generation of drugs that are safe and efficacious.
Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China. As the first and only China-approved third-generation BCR-ABL inhibitor, olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. In November 2021, olverembatinib was approved in China for the treatment of adult patients with TKI-resistant CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation. In January 2023, olverembatinib has been officially included into the China National Reimbursement Drug List, further enhancing the affordability and accessibility of the drug. Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, said, "This indication expansion marks another major milestone for olverembatinib which would not have been possible without the strong support from our regulators and government agencies, as well as the trust and efforts from the investigators and patients who took part in the clinical studies of olverembatinib. We are very encouraged that a broader population of patients in China can now benefit from olverembatinib, a China-developed high-quality global best-in-class novel therapeutic, and to see our persistent innovation bringing meaningful improvement to patients’ lives. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will continue to investigate olverembatinib in additional indications and accelerate our clinical development programs to benefit more patients."
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "We are very excited by this indication expansion for olverembatinib, the first and only China-approved third-generation BCR-ABL inhibitor and a China-developed global best-in-class novel drug. I would like to thank all branches of the Chinese drug regulator for their recognition of olverembatinib’s safety and efficacy and for clearing the drug’s path to bringing survival benefit to more patients. Encouraged by the latest approval, we are ever more confident in pursuing original innovation with our global R&D strategies and in bringing more China-developed globally advanced novel therapeutics to patients in need."
References
O’Brien SG, Guilhot F, Larson R, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. Engl J Med. 2003 Mar 13;348(11):994-1004. Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2014 update on diagnosis, monitoring, and management. Am J Hematol. 2014 May;89(5):547-56. Larson R, Hochhaus A, Hughes T, et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203.
About Olverembatinib (HQP1351)
Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China, the orally active, third-generation tyrosine kinase inhibitor (TKI) olverembatinib is the first and only China-approved third-generation BCR-ABL inhibitor targeting drug-resistant chronic myeloid leukemia (CML). Olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation.
In November 2021, olverembatinib was granted a conditional approval through the Priority Review process by the China National Medical Products Administration (NMPA) for the treatment of adult patients with TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test. Subsequently, Olverembatinib was included into the China 2022 National Reimbursement Drug List (NRDL) for the approved indication. In March 2021, olverembatinib was granted a Breakthrough Therapy Designation (BTD) by the Chinese Center for Drug Evaluation (CDE) for the treatment of patients with CML-CP who are resistant and/or intolerant of first- and second-generation TKIs. In Nov 2023, the New Drug Application (NDA) for this indication was approved by the NMPA through the Priority Review process. In addition, the registrational pivotal Phase III study of olverembatinib for the first-line treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) has already dosed its first patient. In solid tumors, olverembatinib was granted a BTD by the CDE in June 2023 for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.
In overseas, olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. Since 2018, the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) Annual Meetings for five consecutive years, and was nominated for "Best of ASH" in 2019. To date, olverembatinib has been granted one Fast Track Designation (FTD) and four Orphan Drug Designations (ODDs) from the US Food and Drug Administration (FDA) for the treatment of CML, ALL, acute myeloid leukemia (AML), and GIST; and one Orphan Designation from the European Medicines Agency (EMA) of the European Union for the treatment of CML.
In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.
*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.
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 9 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 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.
Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.
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, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its 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.
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