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Chi-Med began submitting Surufatinib's application to the FDA for the treatment of advanced neuroendocrine tumors

 Last Update: 2021-01-02
 Source: Internet
 Author: User

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Neuroendocrine tumors are tumors that originate from neuroendocrine cells.
neuroendocrine cells are a large class of cells in the body that have neuroendocrine esologies and can produce a variety of hormones.
China Medical Technology Co., Ltd. (Chi-Med) today announced that it has begun filing with the U.S. Food and Drug Administration (FDA) a new drug application (NDA) for Surufatinib's treatment of pancreatic and non-pancreatic neuroendocrine tumors.
Chi-Med plans to complete the NDA submission in the first half of 2021, which will be the company's first NDA in the United States.
NDA is based on two positive Phase III studies in China and from patients with non-pancreatic and pancreatic neuroendocrine tumors in the United States.
based on the scientific recommendations of the Human Medicines Commission (CHMP), the package will also be used to submit a sales authorization application (MAA) to the European Medicines Agency (EMA).
Surufatinib has shown significant clinical benefits in patients with advanced oncology, and the NDA application to the FDA marks an important step toward the goal of commercializing surufatinib and other new therapies," said Dr. Marek Kania, chief medical officer of chi-Med.
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