Shanghai Henlius Biotech (Henlius) announced that its anti-PD-1 monoclonal antibody (mAb), Hansizhuang (serplulimab), has been approved by the European Commission (EC) for certain type of lung cancer patients.
The approval allows its use with carboplatin and etoposide as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Serplulimab, marketed as Hetronifly in Europe, is now said to be the first and only anti-PD-1 mAb approved in the European Union (EU) for ES-SCLC treatment.
In December 2022, serplulimab received orphan drug designation from the EC for SCLC treatment. This designation provides policy support in research and development (R&D), registration, and commercialisation in the EU.
In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending Hetronifly for approval in the EU.
China-based Henlius has focused Hansizhuang on lung and gastrointestinal cancers. Over 4,800 subjects worldwide have participated in serplulimab’s trials.
In 2023, Henlius partnered with India-based Intas Pharmaceuticals, granting exclusive rights to develop and commercialise serplulimab in over 50 countries, including Europe and India.
This recent approval covers all 27 EU member states and the European Economic Area countries. Intas’ subsidiary, Accord Healthcare, will lead commercialisation in Europe.
Henlius executive director and CEO Jason Zhu said: “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.”
The latest approval is based on data from the ASTRUM-005 study, a Phase 3 randomised, double-blind, placebo-controlled trial.
This study evaluated Hansizhuang in combination with chemotherapy versus placebo plus chemotherapy as a first-line treatment for ES-SCLC.
Conducted at 128 sites across countries like China, Poland, Turkey, and Georgia, the study enrolled 585 subjects.
Based on ASTRUM-005 results, serplulimab was approved in China, Southeast Asia, and the EU for ES-SCLC, becoming the first anti-PD-1 mAb approved for this indication.
Henlius is also conducting a US head-to-head bridging trial comparing serplulimab with atezolizumab, the current standard of care, to support its US regulatory submission.
In 2023, Henlius’ manufacturing facilities and production lines for Hansizhuang passed EU Good Manufacturing Practice (GMP) inspections.
The company operates three facilities in Shanghai, which include the Xuhui Facility, the Songjiang First Plant, and the Songjiang Second Plant, with a total commercial capacity of 48,000 litres.
