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    Home > Active Ingredient News > Drugs Articles > Suofentinib, a new drug of Hehuang pharmaceutical, has been reported for priority review

    Suofentinib, a new drug of Hehuang pharmaceutical, has been reported for priority review

    • Last Update: 2019-12-16
    • Source: Internet
    • Author: User
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    On December 12, CDE website updated news that the listing application of suofantinib, a new class 1 drug of Hehuang pharmaceutical, was proposed to be included in the priority review The specific information is as follows: (source: CDE) suofantinib is the second class 1 new drug independently developed and applied for listing by Hehuang pharmaceutical after fuquantinib Sofantini is the first innovative drug in China to terminate clinical trials in advance due to its good curative effect It is used to treat advanced non pancreatic neuroendocrine tumor (net), opening the era of targeted treatment of non pancreatic neuroendocrine tumor in China Sufatinib, the second class 1 new drug of Hehuang pharmaceutical, is a selective inhibitor of tyrosine kinase activity and colony stimulating factor-1 receptor (CSF) related to vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR) -Fibroblast growth factor receptor (FGFR) is a candidate drug for oral administration of 1R), which plays a role in tumor growth Colony stimulating factor-1 receptor (CSF-1R) is involved in blocking the signal pathway of tumor related macrophage activation, which can protect cancer cells from the killer attack of T cells Sofantini is the second class 1 new drug independently developed and applied for marketing by Hehuang pharmaceutical, and also the first tumor candidate drug independently completed the concept validation test in China and expanded to the United States for clinical research The curative effect is too good Phase III and Huang Pharma were terminated in advance and submitted suofantinib's listing application in November 2019 The indication is advanced non pancreatic neuroendocrine tumor This listing application is based on the successful sanet EP clinical research data Sanet EP is a phase III critical study of suofantinib's indications for advanced non pancreatic neuroendocrine tumors In June 2019, the independent data monitoring committee (IDMC) of the study assessed that a total of 198 patients in the mid-term analysis successfully reached the pre-set primary efficacy end point of progression free survival (PFS) and terminated the study ahead of time Sofantini should be the first to terminate phase III clinical treatment in advance The results showed that suvantinib reduced the progression or mortality of the disease by 67% and was generally well tolerated According to the researchers' assessment, median PFS was 9.2 months in the suvantinib group, compared with 3.8 months in the placebo group The therapeutic effects of sofantini were observed in all subgroups, and these therapeutic effects were supported by statistical data of significant improvement including objective response rate (ORR), disease control rate (DCR), time to remission (TTR), duration of remission (DOR) and other secondary efficacy endpoints (data source: drug clinical trial registration and information publicity platform) opened the domestic era of targeted treatment of non pancreatic neuroendocrine tumors (net) originated from cells interacting with the nervous system or hormone producing glands According to the origin, neuroendocrine tumors are usually divided into pancreatic neuroendocrine tumors and non pancreatic neuroendocrine tumors Compared with other tumors, the survival time of neuroendocrine tumor patients is relatively long Therefore, although the incidence rate of neuroendocrine tumors is relatively low, the patients are relatively large It is estimated that there will be about 141000 neuroendocrine tumor patients in the United States in 2018, of which more than nine will become non pancreatic neuroendocrine tumor patients In China, there are about 67600 newly diagnosed cases of neuroendocrine tumors in 2018 According to China's incidence rate and prevalence ratio, there are up to 300 thousand neuroendocrine tumors in China It is estimated that about 80% of Chinese patients with neuroendocrine tumors are non pancreatic neuroendocrine tumors At present, the target drugs approved in China include sunitinib malate (trade name: sotan) and Everest (trade name: fenitrol), which are used to treat pancreatic neuroendocrine tumor or highly differentiated non functional gastrointestinal or pulmonary neuroendocrine tumor Hehuang pharmaceutical has all the rights of sofantini in the world If sofantini is approved successfully, it will fill the gap of targeted treatment of non pancreatic neuroendocrine tumor in China At the same time, other indications of suvantinib are also in progress In March 2019, a phase II / III clinical trial was launched with Huang Pharma to compare the efficacy and safety of suvantinib and capecitabine in the treatment of advanced cholangiocarcinoma patients with first-line chemotherapy failure The main end point was OS Because suvantinib has dual mechanisms of anti-tumor angiogenesis and immune regulation, it may be very suitable for combination with other immunotherapies From November 2018 to September 2019, several cooperation agreements were reached with Huang Pharma to evaluate the safety, tolerance and efficacy of suofantinib combined with PD-1 mAb It includes the cooperation agreement with Junshi biology in the global development of suofentini and tuoyi combined therapy, and the cooperation agreement with Cinda biology in the global development of Dabusu combined therapy (source: drug clinical trial registration and information publicity platform) was awarded the orphan drug qualification in the United States on November 25th, and Huang medicine announced that surufatinib was awarded the orphan drug qualification by the United States FDA for the treatment of pancreatic neuroendocrine tumor (NET) If the qualification of orphan drug is approved by FDA, suvantinib will obtain the market monopoly right for 7 years Orphan drug qualification can also bring certain development costs and benefits in the United States (source: FDA) and Huang pharmaceutical R & D pipeline (source: Official Website of he Huang pharmaceutical, updated on September 30, 2019)
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