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Eisai and Henlius Join Forces for Serplulimab in Japan

Eisai Co., Ltd. and Shanghai Henlius Biotech, Inc. have officially announced a significant milestone today with the completion of an exclusive marketing and co-exclusive licensing agreement for the anti-PD-1 antibody, Serplulimab, within Japan. With this agreement, Eisai gains the exclusive rights to market Serplulimab, which is known generically and sold in the EU under the brand name Hetronifly®.

Developed by Henlius, Serplulimab is a novel monoclonal anti-PD-1 antibody distinguished by its unique binding mode, setting it apart from existing anti-PD-1 therapies. In China, the antibody has secured approval for several indications, including non-small cell squamous lung cancer, extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous carcinoma. Remarkably, it holds the distinction of being the first anti-PD-1 antibody globally to be approved as a first-line treatment for ES-SCLC in the EU.

Currently, Henlius is engaged in a Phase II bridging study for ES-SCLC in Japan, eyeing a pivotal approval application in fiscal year 2026. This move will be guided by the findings from the ongoing bridging study and Phase III data that supports the approvals in both China and Europe. Furthermore, Henlius is orchestrating a multinational Phase III clinical trial targeting metastatic colorectal cancer without high microsatellite instability (MSI-H) and plans to expand development into additional indications in the future.

Under the terms of their agreement, Eisai will pay Henlius an upfront sum of $75 million, along with milestone payments relating to regulatory approvals amounting up to $80.01 million, and additional sales milestone payments of up to $233.3 million. Additionally, Henlius will receive double-digit royalties based on product sales. Eisai has indicated that this agreement will not affect its consolidated financial forecasts for the fiscal year ending March 31, 2026.

Dr. Jason Zhu, CEO of Henlius, expressed enthusiasm about the collaboration, noting, “We are excited to partner with Eisai to advance the development of Serplulimab in this important market. By combining Henlius’s innovative capabilities with Eisai’s robust local expertise, we aim to support efficient development and address the urgent medical needs of patients in Japan.”

Echoing this sentiment, Toshihiko Yusa, Executive Officer and Head of Eisai's Japan Business, stated, “Serplulimab has already demonstrated its potential in areas with significant unmet medical needs and has received approvals in China and the EU. Eisai is committed to working closely with Henlius to make Serplulimab available to patients in Japan as soon as possible.”

This collaboration marks a critical development in the fight against cancer in Japan, promising to enhance treatment options and ultimately improve patient outcomes. As both companies align their resources and expertise, the healthcare landscape in Japan is set to witness significant advancements in cancer therapy.