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Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

December 28, 2020

Via: BioSpace

Hutchison China MediTech (Chi-Med) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) – the first portion of a rolling submission for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”). Chi-Med plans to complete the NDA submission in the first half of 2021, which would be the company’s first NDA in the U.S.

The Fast Track Designation granted earlier this year by the FDA permits the company to submit sections of the NDA on a rolling basis.

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