Good news! Hqp1351, the core product under development of AXA pharmaceutical, has obtained the qualification of fast tra

source: | author:webadmin | release time: 2020-05-09 | views:37

Recently, there is good news in the field of chronic myeloid leukemia (CML): on May 7, 2020, the U.S. Food and Drug Administration (FDA) has granted the hqp1351 fast channel qualification (FTD) to the core of AXA Pharma, which is used to treat chronic myeloid leukemia (CML) patients with specific gene mutations that fail to treat the existing tyrosine kinase inhibitor (TKI). This It is the first FTD obtained by AXA.
The U.S. FTD was established to accelerate drug development and rapid review of serious diseases to address the critical unmet clinical medical needs in key areas. Hqp1351 obtained FTD this time, which means that it has the opportunity to speed up the review process in various forms, including more frequent meetings and communication with FDA in the R & D stage; under the condition that relevant standards are met, the rolling review mechanism is implemented, and the NDA application materials can be submitted in stages, instead of being submitted for review after all the materials are completed; the award of fast track qualification also It is expected to further obtain the qualification for priority review and accelerated approval.
One of the key points for FTD identification is how to solve the unmet medical needs so that patients can have new benefits, including the first treatment for specific serious diseases, the significant clinical advantages of the existing treatment compared to the existing treatment, and the benefits for patients who are not effective or intolerant of the existing treatment. The fact that hqp1351 can obtain FTD indicates that FDA has the potential to solve the unmet medical needs in the above aspects.
Hqp1351 is an original class 1 new drug in the research of Yasheng pharmaceutical. It is the third generation bcr-abl inhibitor by oral administration. It is the first third generation bcr-abl targeted CML treatment drug in China. It has outstanding effect on bcr-abl and a variety of BCR-ABL mutants including T315I mutation. It is used to treat first generation and second generation TKI resistant CML patients. At present, it is in the critical phase II clinical trial stage, and it is planned to submit a new drug listing application (NDA) in China this year. In July 2019, the product was approved by the US FDA for clinical trial and directly entered the stage IB clinical study.
In addition to the above gratifying news, on May 4, 2020, the U.S. FDA has awarded hqp1351 orphan drug qualification for the treatment of chronic myeloid leukemia (CML). This determination will help the drug enjoy certain policy support in the follow-up R & D and commercialization in the United States, including 50% of the clinical trial cost tax relief, exemption of NDA application fees, access to FDA R & D funding, etc., in particular, it can obtain 7-year exclusive rights in the U.S. market after being approved for listing. It is worth noting that hqp1351 is the first Chinese new drug project to obtain FDA orphan drug qualification certification on CML indications.
CML is a rare malignant hematologic disease, and its incidence rate is about 1.9/10 in the United States. With the launch of TKI targeting bcr-abl, the treatment of CML has been innovated. Although imatinib, the first generation bcr-abl inhibitor, and several second-generation drugs introduced subsequently have significant clinical benefits in the treatment of CML, acquired drug resistance has been the main challenge in the treatment of CML. The mutation of BCR-ABL kinase region is one of the important mechanisms of acquired drug resistance, and T315I mutation is one of the common types of drug-resistant mutations, with the incidence of about 25% in drug-resistant CML. CML patients with T315I mutation are resistant to all the first and second generation bcr-abl inhibitors. Therefore, the third generation bcr-abl inhibitors which can effectively treat T315I mutant CML are urgently needed. Although the third generation of TKI has been approved for marketing in the United States, its safety still needs to be further improved. This means that for CML patients who have no effect on TKI treatment, more safe and effective treatment drugs are still unmet and urgent clinical needs.
It is worth mentioning that since 2018, the progress of hqp1351 phase I clinical trial in China has been selected into the oral report of the annual meeting of the American Society of Hematology (ash) for two consecutive years, and has been nominated as the "best research" in 2019 ash. The preliminary clinical study results showed that hqp1351 had satisfactory efficacy and safety, and showed good tolerance.
Professor Huang Xiaojun, director of Hematology Research Institute of Peking University and director of Hematology Department of Peking University People's Hospital, who is the main researcher in charge of Chinese clinical research of hqp1351, said: "overcoming the resistance of Gleevec is an urgent clinical demand that has not been met at the global level. HQP135 is a new and effective third generation BCR-ABL inhibitor developed by China's indigenous innovation enterprises. In our phase I study with a large sample size, hqp1351 showed good safety and effectiveness, and many relapsed refractory CML patients without drug treatment obtained clinical response. Hqp1351 will provide clinicians with new treatment weapons and new treatment options for drug-resistant CML patients. Meanwhile, it also shows great progress in the research and development of new drugs in China. This time, hqp1351 won the FDA fast track qualification, which not only shows the degree of international recognition of Chinese clinical data, but also enables patients from more countries to benefit more quickly. We look forward to the follow-up clinical progress of hpq1351, so as to benefit patients all over the world as soon as possible. "
Professor Huang Xiaojun, director of Hematology Research Institute of Peking University and director of Hematology Department of Peking University People's Hospital, who is the main researcher in charge of Chinese clinical research of hqp1351, said: "overcoming the resistance of Gleevec is an urgent clinical demand that has not been met at the global level. HQP135 is a new and effective third generation BCR-ABL inhibitor developed by China's indigenous innovation enterprises. In our phase I study with a large sample size, hqp1351 showed good safety and effectiveness, and many relapsed refractory CML patients without drug treatment obtained clinical response. Hqp1351 will provide clinicians with new treatment weapons and new treatment options for drug-resistant CML patients. Meanwhile, it also shows great progress in the research and development of new drugs in China. This time, hqp1351 won the FDA fast track qualification, which not only shows the degree of international recognition of Chinese clinical data, but also enables patients from more countries to benefit more quickly. We look forward to the follow-up clinical progress of hpq1351, so as to benefit patients all over the world as soon as possible. "
Dr. Yang Dajun, chairman and CEO of AXA Pharma, said: "as the third generation bcr-abl inhibitor originally produced in China, hqp1351 has successively obtained the FDA orphan drug qualification and fast channel qualification, which is a major milestone in the global clinical development of hqp1351 and even the development of the whole company. On the one hand, FDA's awarding of two qualifications of hqp1351 shows the urgency of the clinical needs of CML treatment that are not fully met at the global level, on the other hand, it also reflects the recognition of the safety and effectiveness of the past clinical data of hqp1351. Obtaining this fast track qualification will help us to strengthen our communication and cooperation with FDA in further clinical development, and accelerate the progress of clinical trials and market registration of hqp1351 in the United States and even in the world. We will adhere to the mission of "solving the unmet clinical needs of patients in China and even in the world", and spare no effort to accelerate the development, so as to provide more safe, effective and better treatment options for CML patients. "