Suzhou, China and Rockville, MD /PRNewswire/ - 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, today announced that Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma's, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML). This is Ascentage Pharma's first NDA submission since its inception. If approved, HQP1351 will become the first third-generation BCR-ABL inhibitor therapeutics in China.
Ascentage Pharma recently engaged in pre-NDA discussions with the CDE regarding the NDA based on results from two pivotal studies in patients with T315I-mutant CP-AML and AP-CML. The CDE has agreed that the company should proceed to submit the NDA for those two indications.
CML is a hematologic malignancy of the white blood cells. BCR-ABL tyrosine kinase inhibitors (TKI) have significantly improved the clinical management of CML. However, despite clinical benefits offered by the first-generation BCR-ABL inhibitor imatinib (GLEEVEC®), and several second-generation TKIs, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for effective treatment.
HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. In July 2019, HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. In May 2020, HQP1351 was granted an Orphan Drug Designation and a Fast Track Designation by the US FDA.
"As Ascentage Pharma's first NDA and one that may lead to the market authorization of the first third-generation BCR-ABL inhibitor in China, this submission marks a major milestone for our company," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "For patients with CML who cannot be effectively treated by currently available TKIs, there remains an urgent unmet medical need for safer and more effective therapies. We hope that HQP1351 will bring a breakthrough to the current conundrum and benefit more patients."
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, 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 eight 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. 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 30 Phase I/II clinical trials in the US, Australia, and China. The company's core drug candidate HQP1351 is in pivotal Phase II studies in China for the treatment of drug-resistant chronic myeloid leukemia, and recently granted orphan drug and fast-track designations by the US Food and Drug Administration (FDA). A New Drug Application for HQP1351 has already been submitted in China.
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