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Chi-Med rare tumor drug gets priority-review status in China

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Chi-Med rare tumor drug gets priority-review status in China

Hutchison China MediTech Ltd. said China's medicines regulator granted priority-review status to the new drug application for surufatinib for treating a rare type of gastrointestinal tumor.

China's National Medical Products Administration will now accelerate the review process for surufatinib for treating patients with advanced non-pancreatic neuroendocrine tumors.

Chi-Med's application to market surufatinib for the above-mentioned indication was accepted by the Chinese drug watchdog in November.

Neuroendocrine tumors originate in cells that interact with the nervous system or in glands that produce hormones. They are most often seen in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic or non-pancreatic.

Surufatinib has also received orphan-drug designation for treating pancreatic neuroendocrine tumors by the U.S. Food and Drug Administration.

About 67,600 people were newly diagnosed with neuroendocrine tumors in China in 2018, with up to 300,000 individuals having the disease nationwide. An estimated 80% of these patients have the non-pancreatic type, according to data from Frost and Sullivan.

Approved targeted therapies include Pfizer Inc.'s Sutent and Novartis AG's Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, nonfunctional gastrointestinal or lung neuroendocrine tumors.