Japanese pharmaceutical giant Eisai has forged an oncology licensing deal worth up to $388m with Shanghai Henlius Biotech.
Through this deal, Eisai will pay $75m up front for the rights to develop and commercialise Henlius’ marketed anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) Hetronifly (serplulimab) in Japan, which has already gained approval across several solid tumour indications within China.
Henlius will also be eligible to receive regulatory and sales milestone payments of up to $80m and $233m, respectively, as well as double-digit royalties on any sales made within the country.
According to Eisai, Hetronifly has a “unique binding mode distinct from existing anti-PD-1 antibodies,” which could have the potential set it apart from the drugs already on the Japanese market.
Eisai’s agreement comes hot on the heels of the European Commission’s (EC) call to approve Hetronifly alongside carboplatin and etoposide as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), which was announced on 5 February.
Intas Pharmaceuticals acquired the European rights to Hetronifly back in 2023. The anti-PD-1 drug also became the first therapy in its class globally to gain approval in frontline ES-SCLC following a positive decision from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
To prepare Hetronifly for commercial readiness in Japan, Henlius is currently running several trials on the drug in Japan – including a Phase II study (NCT06812260) in ES-SCLC.
Henlius plans to submit an approval application to regulators in 2026 based on these results, as well as the outcomes of the Phase III studies supporting approval in China and Europe.
The Chinese biotech also plans to conduct a Japanese clinical trial in the perioperative gastric cancer setting, while assuming responsibility as the marketing authorisation holder.
PD-1 remains a sought-after target
Eisai’s agreement with Henlius comes as PD-1-targeting therapies continue to represent a sizable market opportunity for pharma companies, with MSD’s Keytruda (pembrolizumab) bringing in $31.7bn in global sales for the company in FY2025. Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) also had a good 2025 as the drug generated $10bn in revenue globally in 2025 – up 8% YoY.
However, as concerns around tumour resistance grow from continued use of therapies with a single target, companies are increasingly investing in multi-target approaches that can help circumvent a tumour’s acquired resistance.
This trend has seen many pharma companies invest in bispecific antibodies harnessing both PD-1 and vascular endothelial growth factor (VEGF), with titans like AbbVie, Bristol Myers Squibb (BMS), Pfizer and MSD all betting on the target through multi-billion-dollar deals.
In conversation with Pharmaceutical Technology, CEO of oncology biotech Candel Therapeutics warned that an industry-wide focus on the same targets can create redundancy in the system and stifle the efficiency of innovation.
