HUTCHMED announced that it has initiated a Japan registration-enabling bridging study for Surufatinib to support the registration of Surufatinib in the treatment of patients with advanced neuroendocrine tumors (“NETs”). The first patient was dosed on September 15, 2021.

Based on dialogue with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), it was agreed that the Surufatinib Japanese new drug application (“NDA”) for the treatment of advanced NETs include results from a pivotal study to be conducted in Japan, to complement the registration data package supporting the NDA to the U.S. Food and Drug Administration (accepted for review in June 2021) and the Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) (validated in July 2021). The basis for the NDA and the MAA includes data from a U.S. Phase I/II study, as well as the completed Phase III SANET-ep and SANET-p studies used to support marketing authorization in China in advanced NETs, where Surufatinib is currently marketed under the brand name Sulanda.

This Japan study is a two-stage, open label study of Surufatinib where approximately 34 patients are expected to be recruited. In Part 1 of the study, the safety and tolerability of Surufatinib 300mg once daily after 28 days of treatment will be assessed in patients with relapsed/refractory non-haematological malignancies; pharmacokinetics (“PK”) and anti-tumour activity of Surufatinib are secondary endpoints. In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR). The secondary outcome measures include disease control rate (DCR), progression free survival (“PFS”), duration of response (DoR), safety, and PK.

Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan. A global Phase III registration study for Fruquintinib, known as the FRESCO-2 study, is ongoing in patients with refractory metastatic colorectal cancer and is expected to enroll over 680 patients from over 150 sites in 14 countries, including Japan.