echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > The application of suofantinib, a new drug for the treatment of non pancreatic neuroendocrine tumor, has been accepted in China

    The application of suofantinib, a new drug for the treatment of non pancreatic neuroendocrine tumor, has been accepted in China

    • Last Update: 2019-11-13
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Yigu news on November 12, Hehuang China Pharmaceutical Technology Co., Ltd (hereinafter referred to as "Hehuang pharmaceutical") announced that suufatinib's new drug application for the treatment of advanced non pancreatic neuroendocrine tumors (NDA) has been accepted by the National Drug Administration of China (nmpa) and has become jiaiyou ® (furquitinib capsule for colorectal cancer treatment) after its successful launch in China last year, Hehuang Pharmaceutical Co., Ltd is the second innovative cancer drug independently developed and submitted a new drug listing application in China The new drug 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, and there is no effective treatment for these patients The positive results of this study were published in oral report at the annual meeting of the European Society of Oncology (ESMO) on September 29, 2019 Neuroendocrine tumor (net) originated from the cells interacting with the nervous system or hormone producing glands, which can occur in any part of the body, most commonly in the digestive tract or lung, and can be benign or malignant tumor 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 Frost & Sullivan estimates that in 2018, there were about 141000 neuroendocrine tumor patients in the United States, of which 132000 were non pancreatic neuroendocrine tumor patients In China, there are 300000 patients with neuroendocrine tumors and 80% of them are non pancreatic neuroendocrine tumors Currently, there are very limited therapeutic drugs available for neuroendocrine tumor patients, and approved targeted therapies include sotan ® (sunitinib malate) and fenitrol ® (everolimus), which are used to treat pancreatic neuroendocrine tumor or highly differentiated non functional gastrointestinal or pulmonary neuroendocrine tumor Because only for some patients, many patients are still lack of safe and effective treatment options supported by sufficient evidence-based medical evidence, especially the treatment of non pancreatic neuroendocrine tumor is less and less effective, the survival of patients is not optimistic, so new treatment methods are urgently needed to improve the survival of patients Sofantini is a new oral tyrosine kinase inhibitor independently developed by Hehuang pharmaceutical, which has dual activities of anti angiogenesis and immune regulation Sufentanil can block tumor angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), inhibit colony stimulating factor-1 receptor (CSF-1R), and promote immune response to tumor cells by regulating tumor related macrophages Because of its dual mechanism of anti-tumor angiogenesis and immune regulation, suvantinib may be very suitable for combination with other immunotherapies At present, sofantini is carrying out a number of concept validation studies in the United States, and a number of later clinical trials and concept validation studies in China It is reported that the new drug application is based on the number of successful sanet EP clinical studies Sanet EP is a randomized, double-blind, placebo-controlled, multicenter phase III study The study compared daily oral sufentanil with placebo in patients with advanced non pancreatic neuroendocrine tumors who had no effective treatment 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 primary efficacy end point of progression free survival (PFS) and terminated the study ahead of schedule 84% of the patients in the study were grade 2 lesions In 41% of patients, the origin of the disease was beyond the gastrointestinal tract and lungs or unknown 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 efficacy of sufentanil was observed in all subgroups, and these therapeutic effects were supported by significantly improved statistical data including objective response rate (ORR), disease control rate (DCR), time to remission (TTR), remission duration (DoR) and other secondary efficacy endpoint indicators After evaluation, these therapeutic effects were also supported by the blind independent imaging review committee (biirc) Hehuang pharmaceutical plans to carry out a mid-term analysis in the first half of 2020, and complete the group work of patients in 2020 Christian Hogg, chief executive of Hewang pharmaceutical, said: "submitting the application for listing of new drugs means that sofantini is expected to be approved and listed in China, bringing a new treatment option for many patients with very limited choice of treatment methods In order to reach as many patients as possible after suvantinib is approved, we are currently setting up our own cancer drug commercialization team, and expect to be ready when suvantinib goes on the market, covering all relevant hospitals and clinics in China "
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.