Shots:
- Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan
- As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties
- In Japan, Henlius is running a P-II bridging study for ES-SCLC & plans to file a regulatory application in FY’26 using bridging results & P-III data from China & EU. The company is also advancing a P-III global trial in non-MSI-High metastatic CRC & plans a perioperative gastric cancer study in Japan, where it will serve as MA Holder
Ref: PRnewswire  |  Image: Eisai & Henlius | Press Release
Related News: Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)Â
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