Henlius' Serplulimab Makes History as First PD-1 Inhibitor Approved in EU for Small Cell Lung Cancer
Key Insights
Shanghai Henlius Biotech (search)'s serplulimab (Hetronifly) receives European Commission approval as the first anti-PD-1 antibody for extensive-stage small cell lung cancer (search) treatment.
The approval is based on the ASTRUM-005 (search) trial involving 585 patients across multiple countries, demonstrating significant efficacy in combination with carboplatin and etoposide.
The drug has already benefited over 90,000 patients across China, Europe, and Southeast Asia, with Henlius maintaining 48,000-liter manufacturing capacity to ensure consistent global supply.
Shanghai Henlius Biotech (search) achieved a significant milestone as the European Commission (EC) granted approval for serplulimab (marketed as Hetronifly in Europe) in combination with carboplatin and etoposide for the first-line treatment of extensive-stage small cell lung cancer (search) (ES-SCLC) in adult patients. This approval marks serplulimab as the first and only anti-PD-1 monoclonal antibody authorized for ES-SCLC treatment in the European Union.
Groundbreaking Approval Addresses Critical Medical Need
The approval covers all 27 EU member states and European Economic Area countries, including Norway, Iceland, and Liechtenstein. This development is particularly significant given the high unmet need in SCLC treatment, which affects 15-20% of all lung cancer patients and is characterized by aggressive progression and poor prognosis.
According to GLOBOCAN 2022 statistics, lung cancer remains the most prevalent cancer globally, with over 2.48 million new cases in 2022, representing 12.4% of all cancer diagnoses. In the EU specifically, SCLC affects between 1 to 5 per 10,000 people.
Robust Clinical Evidence Supporting Approval
The EC's decision was primarily based on data from the ASTRUM-005 (search) study, a comprehensive Phase 3 clinical trial that enrolled 585 patients across 128 sites in multiple countries, including China, Poland, Turkey, and Georgia. The study's results, which were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), demonstrated the drug's safety and efficacy profile.
Jason Zhu, Executive Director and CEO of Henlius, emphasized the significance of this approval: "This milestone not only underscores our leadership in innovative drug development and global strategy but also brings new hopes to patients suffering from the disease in Europe and beyond."
Manufacturing and Distribution Infrastructure
Henlius has established robust manufacturing capabilities to support global distribution. The company operates three facilities in Shanghai with a total commercial capacity of 48,000 liters, all of which successfully passed EU GMP inspections in 2023. This infrastructure ensures reliable supply to markets across China, Europe, Latin America, the Middle East, North America, and Southeast Asia.
Global Expansion and Partnerships
The commercialization in Europe will be led by Accord Healthcare Ltd, a subsidiary of Intas Pharmaceuticals, following a 2023 collaboration agreement that granted Intas exclusive rights for serplulimab in over 50 countries across Europe and India. To date, serplulimab has benefited more than 90,000 patients across various regions where it has received approval.
Future Developments
Henlius is currently conducting a head-to-head bridging trial in the United States, comparing serplulimab with atezolizumab, the current standard of care, to support its U.S. regulatory submission. This ongoing research demonstrates the company's commitment to expanding access to this innovative therapy globally.