Eisai Co., Ltd. and Shanghai Henlius Biotech, Inc. have entered into an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab in Japan.
Serplulimab, developed by Henlius, offers a novel binding mode distinct from other anti-PD-1 antibodies. Approved in China and the EU for multiple cancer indications, it serves as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Henlius is conducting clinical trials in Japan, targeting ES-SCLC and non-high-frequency microsatellite instability (non-MSI-High) metastatic colorectal cancer.
Under the agreement, Eisai gains exclusive commercialization rights in Japan. Henlius, which assumes the role of Marketing Authorization Holder, plans additional clinical trials for perioperative gastric cancer in the country. The deal includes an upfront payment of USD 75 million from Eisai, with potential regulatory and sales milestone payments reaching up to USD 313.31 million, alongside double-digit sales royalties.
As the collaboration advances, both companies aim to meet unmet medical needs in Japan. Eisai's executive officer, Toshihiko Yusa, highlighted the promising nature of serplulimab for treating ES-SCLC and colorectal cancer, while Henlius CEO Dr. Jason Zhu emphasized the importance of Japan in serplulimab's international journey.
Serplulimab's approval in over 40 markets, including China and the EU, underscores its global impact. Henlius is expanding serplulimab's application through ongoing clinical trials for other cancers, leveraging its platform to address broader unmet medical needs globally.
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