Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 154

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 154
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 in China under the brand name Sulanda. It was approved by the NMPA in December 2020 for the treatment of non-pancreatic NETs and launched in mid-January 2021. This NMPA approval of surufatinib was based on results from the SANET-ep, a China Phase III study in patients with advanced non-pancreatic NETs. The positive results of this trial were highlighted in an oral presentation at ESMO 2019 and published in The Lancet Oncologyin September 2020. In June 2021, surufatinib was approved by the NMPA for the treatment of advanced pancreatic NETs and launched in June 2021. This NMPA approval of surufatinib was based on results from the SANET-p, a China Phase III study in patients with advanced pancreatic NETs. The positive results of this trial were highlighted in an oral presentation at ESMO 2020 and published in The Lancet Oncologyin September 2020. In 2022, we presented a pooled analysis of safety data from the SANET-p and SANET-ep studies at the ASCO 2022.

Surufatinib received FDA Fast Track Designations in April 2020 for the treatment of pNETs and epNETs. Orphan Drug Designation for pNETs was granted in November 2019. In a May 2020 pre-NDA meeting, we reached an agreement with the FDA that the two positive Phase III studies of surufatinib in patients with pNETs and epNETs in China, along with the bridging trial in the U. S. could form the basis to support a U. S. NDA submission. The FDA accepted the filing of the NDA in June 2021. However, in April 2022, we received a Complete Response Letter from the FDA regarding the NDA for surufatinib for the treatment of pNETs and epNETs. Based on interactions with the FDA and EMA, a new multi-regional clinical trial would be required to move forward with this program in the U. S. and Europe. Following dialogue with the PMDA, we have decided not to file a Japanese NDA on the basis of the clinical trial data available at this time.

Surufatinib Pre-clinical Evidence

Surufatinib inhibited VEGFR 1, 2, and 3, FGFR1 and CSF-