Eisai and Henlius Forge Licensing Deal for Serplulimab in Japan
In a significant development for cancer treatment in Japan, Eisai Co., Ltd., based in Tokyo, and Shanghai Henlius Biotech, Inc., have announced a pivotal agreement for the exclusive commercialization of Serplulimab, an innovative anti-PD-1 monoclonal antibody. This agreement allows Eisai to facilitate the drug’s entry into the Japanese market.
Serplulimab, marketed as Hetronifly® in the EU, has garnered attention due to its unique binding mechanism, setting it apart from existing anti-PD-1 therapies. Henlius has successfully secured approvals in China for multiple cancer types, including squamous non-small cell lung cancer and extensive-stage small cell lung cancer (ES-SCLC). Notably, it is the world's first anti-PD-1 antibody to be approved for first-line treatment of ES-SCLC in the European Union.
In Japan, the clinical landscape is evolving. Henlius is conducting a Phase II bridging study targeting ES-SCLC, with plans to submit regulatory applications in fiscal year 2026 leveraging data from this study, alongside Phase III results from China and Europe. Moreover, a multinational Phase III trial focusing on non-MSI-High metastatic colorectal cancer is currently underway, with aspirations for broadening its application in various other indications as well.
The terms of this agreement stipulate that Eisai will handle the commercialization of Serplulimab within Japan. In reciprocity, Henlius is expected to facilitate a clinical trial focused on perioperative gastric cancer in the region, thus assuming the responsibilities typically associated with a Marketing Authorization Holder.
Financially, this agreement outlines a payment structure where Henlius will receive an initial payment of USD 75 million, alongside potential regulatory milestone payments reaching up to USD 80.01 million and sales milestone payments that could accumulate to USD 233.3 million, in addition to double-digit royalties based on sales. Notably, Eisai anticipates that this deal will not influence its consolidated financial forecast for the fiscal year concluding on March 31, 2026.
Dr. Jason Zhu, the CEO of Henlius, expressed optimism, stating, "We are pleased to collaborate with Eisai in Japan to advance the development of serplulimab in this important market." He emphasized the synergy between Henlius' innovative approaches and Eisai's adept local expertise, aiming for a significant impact on patient care in Japan.
Eisai's Executive Officer and Head of Japan Business, Toshihiko Yusa, highlighted the potential of Serplulimab in addressing significant medical needs, reaffirming the company's commitment to expedite its availability to Japanese patients.
In conclusion, this partnership not only marks a step forward for both companies but also has the potential to change the landscape of cancer treatment in Japan significantly. The mutual commitment displayed by Eisai and Henlius signals a bright future for improving patient outcomes through effective therapeutic options.
The agreement is seen as a milestone in bridging innovative biotechnology with commercial health solutions, paving the way for advancements in patient care and treatment availability in Japan’s rapidly evolving pharmaceutical market.
Serplulimab, marketed as Hetronifly® in the EU, has garnered attention due to its unique binding mechanism, setting it apart from existing anti-PD-1 therapies. Henlius has successfully secured approvals in China for multiple cancer types, including squamous non-small cell lung cancer and extensive-stage small cell lung cancer (ES-SCLC). Notably, it is the world's first anti-PD-1 antibody to be approved for first-line treatment of ES-SCLC in the European Union.
In Japan, the clinical landscape is evolving. Henlius is conducting a Phase II bridging study targeting ES-SCLC, with plans to submit regulatory applications in fiscal year 2026 leveraging data from this study, alongside Phase III results from China and Europe. Moreover, a multinational Phase III trial focusing on non-MSI-High metastatic colorectal cancer is currently underway, with aspirations for broadening its application in various other indications as well.
The terms of this agreement stipulate that Eisai will handle the commercialization of Serplulimab within Japan. In reciprocity, Henlius is expected to facilitate a clinical trial focused on perioperative gastric cancer in the region, thus assuming the responsibilities typically associated with a Marketing Authorization Holder.
Financially, this agreement outlines a payment structure where Henlius will receive an initial payment of USD 75 million, alongside potential regulatory milestone payments reaching up to USD 80.01 million and sales milestone payments that could accumulate to USD 233.3 million, in addition to double-digit royalties based on sales. Notably, Eisai anticipates that this deal will not influence its consolidated financial forecast for the fiscal year concluding on March 31, 2026.
Dr. Jason Zhu, the CEO of Henlius, expressed optimism, stating, "We are pleased to collaborate with Eisai in Japan to advance the development of serplulimab in this important market." He emphasized the synergy between Henlius' innovative approaches and Eisai's adept local expertise, aiming for a significant impact on patient care in Japan.
Eisai's Executive Officer and Head of Japan Business, Toshihiko Yusa, highlighted the potential of Serplulimab in addressing significant medical needs, reaffirming the company's commitment to expedite its availability to Japanese patients.
In conclusion, this partnership not only marks a step forward for both companies but also has the potential to change the landscape of cancer treatment in Japan significantly. The mutual commitment displayed by Eisai and Henlius signals a bright future for improving patient outcomes through effective therapeutic options.
The agreement is seen as a milestone in bridging innovative biotechnology with commercial health solutions, paving the way for advancements in patient care and treatment availability in Japan’s rapidly evolving pharmaceutical market.
Topics Health）
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