Serplulimab is a recombinant humanised anti-PD-1 monoclonal antibody (mAb) developed by Henlius. Image Credit: janews / Shutterstock.

Intas Pharmaceuticals has signed an exclusive licensing agreement with Shanghai Henlius Biotech to develop and commercialise serplulimab in Europe and India.

Serplulimab is a recombinant humanised anti-PD-1 monoclonal antibody (mAb) developed by Henlius.

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The antibody was approved by China’s National Medical Products Administration for treating microsatellite instability-high (MSI-H) tumours, squamous non-small cell lung cancer (NSCLC), extensive stage small cell lung cancer (SCLC), and oesophagal squamous cell carcinoma (ESCC).

Serplulimab was launched in China under the brand name Hansizhuang in March 2022. It has also received an orphan drug designation by the US Food and Drug Administration (FDA) and the European Commission (EC) for treating SCLC.

As per the 27 October agreement, Henlius will receive €42m ($44.5m) upfront payment and will be in line to receive up to €43m and €100m in regulatory and sales-based milestone payments, respectively. Furthermore, the China-based company will also be entitled to double-digit royalties on the net profit.

Intas plans to commercialise serpulimab in India while its subsidiary Accord Healthcare will handle the process in Europe. Although Intas has commercialisation rights in Europe and India, Henlius will be responsible for the compound’s clinical development, manufacturing, and supply upon launch.

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GlobalData forecasts serplulimab to generate $1.5bn in global sales in 2029. The drug is being evaluated in multiple Phase III clinical trials in various indications such as limited-stage SCLC and ESCC.

GlobalData is the parent company of Pharmaceutical Technology.

In June 2018, Accord partnered with Henlius to commercialise Roche’s Herceptin (trastuzumab) biosimilar Hanquyou in 53 countries. This included parts of Europe, the Middle East and North Africa