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Surufatinib is a new oral tyrosine kinase inhibitor developed by He huang Medicine, with dual activity against angiogenesty and immunomodulation.
The drug blocks tumor angiogenesphage by inhibiting endodertic growth factor subjects (VEGFRs) and fibroblast growth factors (FGFRs), while inhibiting the set-up stimulation factor 1 subject (CSF-1R), and promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
, Sovantini has submitted two listing applications in China, the declared symptoms are advanced pancreatic neuroendocrine tumor and late pancreatic neuroendocrine tumor.
Neuroendocrine tumors originate from cells that interact with the nervous system or hormone-producing glands, can originate in many parts of the body, commonly found in the digestive tract or lungs, generally divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors.
In 2018, there were about 67,600 newly diagnosed cases of neuroendocrine tumors in China, and according to the ratio of incidence to prevalence in China, there were a total of 300,000 neuroendocrine tumor patients in China, of which about 80% were non-pancreatic neuroendocrine tumors.
Patients with neuroendocrine tumors have a relatively long lifesaver compared to other tumors, and currently approved targeted drugs include Sotan ® (malic acid shonithini) and finito ® (Ivemos), used to treat pancreatic neuroendocrine tumors or highly differentiated non-functional gastrointestinal or pulmonary neuroendocrine tumors.
, Sovantini's application for adaptation to the treatment of advanced non-pancreatic neuroendocrine tumors is based on data from clinical studies SANET-ep.
the study is a key Phase III study on sovantinib's adaptation to advanced non-pancreatic neuroendocrine tumors, double-blindness, placebo control, and multi-center.
June 2019, the Independent Data Monitoring Board (IDMC) assessed that an interim analysis involving 198 patients had successfully reached the predetermed primary efficacy endpoint of progress-free lifetime (PFS) and terminated the study early.
results showed that Sovantinistini had reduced the progress or mortality of the disease by 67 per cent and was generally well-to-bear.
the researchers assessed that the middle PFS was 9.2 months for patients in the Sovantinie treatment group and 3.8 months in the placebo group.
And the therapeutic efficacy of Sovantinie was observed in all subgroups, supported by statistical data that included significant improvements in secondary efficacy endpoint indicators such as objective remission rate (ORR), disease control rate (DCR), time to disease remission (TTR), and duration of remission (DoR).
addition to the two adaptive disorders that have been reported, Sovantini is also being developed to treat bile tube cancer and soft tissue sarcoma.
And Sovantini's unique mechanism of action makes it ideal for use in combination with other immunotherapies, and Yellow Medicine has reached cooperation agreements with Regency, Cynda Andersen and Baiji Shenzhou, respectively, to assess the safety, tolerance and efficacy of Sovantini's combined PD-1 monoclonal antibodies.
In addition, hutchison Whampoa has planned to submit Sovantini's listing application in the United States and the European Union, where sovantinib has been granted fast-track FDA status for the treatment of pancreatic and non-pancreatic neuroendocrine tumors, as well as orphan drug eligibility for the treatment of pancreatic neuroendocrine tumors.
and Huang Pharmaceuticals, an innovative biopharmaceutical company in the commercial phase, have committed to the discovery and global development of targeted drugs and immunotherapy for cancer and immunological diseases over the past 20 years, with nine cancer candidates under global development.
among them, only pyridine was approved in September 2018 in the country for single-drug treatment with fluorouracil, oxalipari and olithycon-based chemotherapy, as well as metastatic colorectal cancer (mCRC) that has been received or is not suitable for anti-vascular endotranscopic growth factor (VEGF) therapy, anti-surface growth factor recipient (EGFR) treatment (RAS wild type).
addition, Voliteni has also submitted a domestic application for the launch of a new drug for non-small cell lung cancer ("NSCLC") with a 14-hop mutation in the exon exon of inter-therapeutic persetretic endoscopic conversion factor ("MET").
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