FDA Accepts Filing of HUTCHMED NDA for Surufatinib to Treat Advanced Neuroendocrine Tumors

 U.S. FDA Accepts Filing of HUTCHMED's NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

- U.S. FDA has assigned a target action date of April 30, 2022 -

- If approved, surufatinib would be HUTCHMED's first novel oncology drug marketed outside of China -

HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration ('FDA') has accepted its filing of the New Drug Application ('NDA') for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ('NETs'). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.

Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: 'This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide. The FDA's acceptance of the NDA highlights the clinical value of this submission package and the importance of bringing more treatment options to US NET patients.'

The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p¹ and SANET-ep² both previously reported in The Lancet Oncology), and a surufatinib study conducted in the U.S.³ The data package will also be used to file a Marketing Authorization Application ('MAA') to the European Medicines Agency ('EMA') imminently, based on scientific advice from the EMA's Committee for Medicinal Products for Human Use.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

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