日本語 
Eisai and Shanghai Henlius Biotech have signed an exclusive commercialization agreement and a co exclusive development and manufacturing license agreement for the anti PD 1 monoclonal antibody serplulimab in Japan. The deal gives Eisai the rights to commercialize the drug in the Japanese market, while development and manufacturing responsibilities are shared under the license terms.
Serplulimab was developed by Henlius and is positioned as a next generation anti PD 1 antibody. Its binding mechanism is different from existing drugs in the same class. In China, the drug has already received regulatory approval for multiple cancer indications. These include non small cell squamous cell lung cancer, extensive stage small cell lung cancer, non small cell lung cancer, and esophageal squamous cell carcinoma. In the European Union, serplulimab is marketed under the name Hetronifly. It has been approved there for extensive stage small cell lung cancer and is notable for being the first anti PD 1 antibody in the world approved as a first line treatment for this indication.
In Japan, Henlius is currently running a Phase II linkage study in extensive stage small cell lung cancer. Based on the results, the company plans to submit a regulatory application in fiscal year 2026. The submission will rely on data from the Japanese linkage study as well as Phase III clinical trial data that supported approvals in China and Europe. At the same time, a multinational Phase III trial is underway for non MSI H metastatic colorectal cancer. Henlius has also indicated that additional cancer indications are planned for future development.
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Under the agreement, Eisai will hold exclusive commercialization rights for serplulimab in Japan. Henlius will take the lead on a clinical trial for perioperative gastric cancer in Japan and will also act as the marketing authorization holder for the product.
On the financial side, Eisai will pay Henlius an upfront fee of 75 million US dollars. The agreement includes regulatory milestone payments of up to 80.01 million US dollars and sales based milestone payments that could reach 233.3 million US dollars. Henlius will also receive double digit royalties on sales. Eisai has stated that it does not expect this agreement to have any impact on its consolidated financial forecasts for the fiscal year ending March 31, 2026.
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