Shanghai Henlius Biotech, Inc. announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC. This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.

Serplulimab is the world's first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab, the company shared in a statement.

In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas' subsidiary, Accord Healthcare Ltd.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, “The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in Europe and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients' lives."