On October 21, 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 that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of the company, priority review to its New Drug Application (NDA) for Olverembatinib (HQP1351) (Press release, Ascentage Pharma, OCT 21, 2020, View Source [SID1234568769]). The NDA of Olverembatinib was submitted based on results from two pivotal studies for the treatment of patients resistant to tyrosine kinase inhibitors (TKI) and with T315I-mutant chronic phase chronic myeloid leukemia and accelerated phase CML.

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Priority review status accelerates research and development of innovative drugs with significant clinical advantages and for which there is an urgent medical need. According to the Provisions for Drug Registration (SAMR Order No. 27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, the regulatory authority will prioritize the review process and evaluation resources for applications with expected shorter review timelines, which helps accelerate the market access of these innovative drugs.

CML is a hematologic malignancy of the white blood cells. BCR-ABL 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, presenting an urgent unmet medical need for effective treatment.

Olverembatinib 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, Olverembatinib was granted an Orphan Drug Designation and a Fast Track Designation for treating CML with specific genetic characteristics by the FDA.

"Olverembatinib is the drug candidate of Ascentage Pharma’s first NDA submission, which will become the first third-generation BCR-ABL inhibitor therapeutics in China," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This priority review granted to Olverembatinib will help expedite the approval process, hopefully soon changing the current treatment options for patients with CML in China who cannot be effectively treated by currently available TKIs. We hope Olverembatinib will soon be approved to benefit more patients."