China’s NMPA rejects fruquintinib for second line gastric cancer

Chinese biopharma Hutchmed (HKEX:13) on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma.

The company said it will evaluate a new route forward. Following an additional internal review of the current data package, in light of recent discussions with the National Medical Products Administration of China (NMPA), Hutchmed has determined that the submission is unlikely to support an approval in China at this time.

Fruquintinib is already approved in China, where US pharma major Eli Lilly (NYSE: LLY) has co-marketing rights, as Elunate for third-line colorectal cancer. It is also authorized under the trade name Fruzaqla in the USA, where Hutchmed sold rights to Takeda (TYO: 4502) for $400 million, citing tough market conditions and a focus on its most profitable activities.