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China's independently researched and developed new anticancer drugs won FDA breakthrough therapy certification
New Beijing News
2019-01-15 13:24:46
https://www.toutiao.com/a6646590252007817742/
New Beijing News (Reporter Zhang Xiulan) On January 15, Baekje Shenzhou revealed that the US Food and Drug Administration (FDA) granted a breakthrough in the treatment of Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib. It is used to treat adult mantle cell lymphoma (MCL) patients who have previously received at least one treatment. This is also the first Chinese self-developed anticancer drug that has been approved by the FDA for breakthrough therapy.
Zanubrutinib is a new BTK inhibitor developed by Baekje Shenzhou. The drug is designed to maximize the specific binding rate to BTK targets while minimizing off-target effects. This is the first FDA breakthrough therapy in mainland China. New drugs identified.
In August and October 2018, Baekje Shenzhou submitted to the State Food and Drug Administration for the treatment of relapsed or refractory mantle cell lymphoma (MCL) and relapsed refractory chronic lymphocytic leukemia (CLL)/small lymphocyte lymphocytes. SLR (SLL) new drug listing application, both applications have been included in the priority review channel by the Drug Evaluation Center, and is expected to be listed in China in 2019. After approval, it will be put into operation at the small molecule drug production base in Baiji Shenzhou Industrial Park in Suzhou.
The Breakthrough Therapy Designation channel was established by the FDA in July 2012 to accelerate the development and registration of drugs for the treatment of serious diseases and to demonstrate good efficacy in early clinical development. After accelerating approval and prioritizing reviews, the FDA has another important new drug review channel. According to the regulations, if the new drug in research and development is approved by breakthrough therapy, the FDA will provide various forms of support, including guidance from FDA officials, organizational commitments with senior management, and qualifications for rolling review and priority review. .
In general, drugs that have been approved for breakthrough therapy are subject to two conditions, one for treating diseases that pose a serious threat to the patient's life and the other, and the important clinical endpoints that have sufficient clinical early data to prove that they are present. There is a fundamental breakthrough compared to treatment. That is to say, these drugs have achieved significant improvements in important clinical research endpoints for some of the most unmet clinical needs. This zanubrutinib was awarded a breakthrough therapy award, which is benefiting from previous results in a series of clinical trials, including good data from a variety of B-cell malignancies such as mantle cell lymphoma.
In December 2018, during the American Congress of Hematology (ASH), Professor Song Yuqin from Peking University Cancer Hospital said that the new BTK inhibitor zanubrutinib did show excellent efficacy in MCL patients in a relapsed or refractory MCL against China. In a critical phase 2 clinical trial of patients, 86 patients were enrolled, with an overall response rate (ORR) of 84% and a complete response (CR) rate of 59%. At the same time, the safety of the drug is also very good, and the incidence of adverse reactions above grade 3 is low.
It is reported that Baekje Shenzhou is conducting extensive clinical research on multiple indications such as mantle cell lymphoma (MCL) and Walden's macroglobulinemia (WM), including seven phases or key factors in global or China. In a clinical trial, a phase 3 clinical trial of patients with relapsed and refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) versus ibbutinib is ongoing worldwide. Currently, more than 1,500 patients worldwide have been treated with zanubrutinib.
Previously, zanubrutinib had received three FDA authorizations for orphan drugs, and in July 2018, the FDA granted fast-track qualifications for the treatment of WM patients. It is reported that Baekje Shenzhou plans to submit a new drug listing application to the FDA in 2019 or early 2020.
New Beijing News
2019-01-15 13:24:46
https://www.toutiao.com/a6646590252007817742/
New Beijing News (Reporter Zhang Xiulan) On January 15, Baekje Shenzhou revealed that the US Food and Drug Administration (FDA) granted a breakthrough in the treatment of Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib. It is used to treat adult mantle cell lymphoma (MCL) patients who have previously received at least one treatment. This is also the first Chinese self-developed anticancer drug that has been approved by the FDA for breakthrough therapy.
Zanubrutinib is a new BTK inhibitor developed by Baekje Shenzhou. The drug is designed to maximize the specific binding rate to BTK targets while minimizing off-target effects. This is the first FDA breakthrough therapy in mainland China. New drugs identified.
In August and October 2018, Baekje Shenzhou submitted to the State Food and Drug Administration for the treatment of relapsed or refractory mantle cell lymphoma (MCL) and relapsed refractory chronic lymphocytic leukemia (CLL)/small lymphocyte lymphocytes. SLR (SLL) new drug listing application, both applications have been included in the priority review channel by the Drug Evaluation Center, and is expected to be listed in China in 2019. After approval, it will be put into operation at the small molecule drug production base in Baiji Shenzhou Industrial Park in Suzhou.
The Breakthrough Therapy Designation channel was established by the FDA in July 2012 to accelerate the development and registration of drugs for the treatment of serious diseases and to demonstrate good efficacy in early clinical development. After accelerating approval and prioritizing reviews, the FDA has another important new drug review channel. According to the regulations, if the new drug in research and development is approved by breakthrough therapy, the FDA will provide various forms of support, including guidance from FDA officials, organizational commitments with senior management, and qualifications for rolling review and priority review. .
In general, drugs that have been approved for breakthrough therapy are subject to two conditions, one for treating diseases that pose a serious threat to the patient's life and the other, and the important clinical endpoints that have sufficient clinical early data to prove that they are present. There is a fundamental breakthrough compared to treatment. That is to say, these drugs have achieved significant improvements in important clinical research endpoints for some of the most unmet clinical needs. This zanubrutinib was awarded a breakthrough therapy award, which is benefiting from previous results in a series of clinical trials, including good data from a variety of B-cell malignancies such as mantle cell lymphoma.
In December 2018, during the American Congress of Hematology (ASH), Professor Song Yuqin from Peking University Cancer Hospital said that the new BTK inhibitor zanubrutinib did show excellent efficacy in MCL patients in a relapsed or refractory MCL against China. In a critical phase 2 clinical trial of patients, 86 patients were enrolled, with an overall response rate (ORR) of 84% and a complete response (CR) rate of 59%. At the same time, the safety of the drug is also very good, and the incidence of adverse reactions above grade 3 is low.
It is reported that Baekje Shenzhou is conducting extensive clinical research on multiple indications such as mantle cell lymphoma (MCL) and Walden's macroglobulinemia (WM), including seven phases or key factors in global or China. In a clinical trial, a phase 3 clinical trial of patients with relapsed and refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) versus ibbutinib is ongoing worldwide. Currently, more than 1,500 patients worldwide have been treated with zanubrutinib.
Previously, zanubrutinib had received three FDA authorizations for orphan drugs, and in July 2018, the FDA granted fast-track qualifications for the treatment of WM patients. It is reported that Baekje Shenzhou plans to submit a new drug listing application to the FDA in 2019 or early 2020.
