NMPA accepts application sufaninib for new drug from Huang Chinese pharmaceutical company Surufatinib
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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The Nationalmedicines(http://Regulatory Authority (NMPA) has accepted the application for listing of thenew drug(http://for the treatment of advanced non-pancreatic neuroendocrine tumors, the(http://, a limitedcompanyhttp:// announced recent
lyThis application for new drug listing is based on successful SANET-ep clinical research dataSANET-ep is a critical phase III study of sofantine's adaptation of advanced non-pancreatic neuroendocrine tumors, which currently do not have an effective treatmentThe positive results of the study were announced earlier in an oral report at the annual meeting of the European Society for Oncology (ESMO) on September 29, 2019 Hutchison now has all the rights of Sofantini worldwide Sofanti is conducting research on multiple solid tumors as a single-drug therapy or in combination with other tumor immunotherapy therapy in China, the United States and Europe Sofantini is following the successful launch of the ® (the furanitini capsule for colorectal cancer treatment) in China last year, and the second independent research and development of Huang Pharma and the submission of new drug applications in China for the of innovative oncology drugs (http:// SANET-ep is a randomized, double-blind, placebo-controlled, multicenter Phase III study The study compared daily oral sofantine with a placebo in patients with low- and low-stage advanced non-pancreatic neuroendocrine tumors without an effective treatment In June 2019, the Independent Data Monitoring Board (IDMC) assessed that a total of 198 patients participated in the mid-term analysis (http:// successfully reached the end of the pre-optimal end of the non-progressive survival (PFS) and terminated the study early Eighty-four percent of the patients involved in the study had stage 2 lesions Forty-one percent of patients with disease originated outside the gastrointestinal tract and lungs or from unknown sources
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