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Eisai becomes a checkpoint player

Given Keytruda’s dominance as the backbone of numerous anticancer regimens, any company with serious aspirations in oncology needs to have an anti-PD-(L)1 drug in its portfolio to be able to compete. And if one isn’t readily available in house the next best thing is to license one in, as Eisai just did in buying Japanese rights to Shanghai Henlius’s serplulimab for $75m up front. The drug is already established in China in five approved indications under the trade name Hansizhuang, and got its first EU approval, for first-line extensive-stage SCLC as Hetronifly, a year ago. But it has no presence in Japan, where Henlius is running a bridging study aimed at a 2026 filing. That said, it’s not clear whether Eisai wants to establish serplulimab in Japan to challenge the leaders in this space, or simply needs it as a backbone of future combinations with its own drugs, the most obvious of which might be Lenvima (currently established as part of a Keytruda combo). PD-(L)1 blockers being developed mostly for combo use include AbbVie’s budigalimab, Johnson & Johnson’s cetrelimab and Boehringer Ingelheim’s ezabenlimab. Serplulimab is separately licensed to Fosun in the US, but isn’t approved there.

 

Selected serplulimab indications

IndicationStudyStatus in ChinaStatus in EU
Neoadjuvant & adjuvant gastric cancer (chemo combo)Astrum-006Awaiting approvalNA
1st-line non-sq NSCLC (chemo combo)Astrum-002Approved Dec 2024NA
1st-line oesophageal squamous cell carcinoma (chemo combo)Astrum-007Approved Sep 2023NA
1st-line SCLC (chemo combo)Astrum-005Approved Jan 2023Approved Feb 2025
1st-line sq NSCLC (Abraxane combo)Astrum-004Approved Nov 2022Awaiting approval
MSI-high solid tumours (monotherapy)NCT03941574Approved Mar 2022NA

Source: OncologyPipeline.

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