Shanghai Henlius Biotech Inc. (2696.HK) received approval from the European Commission for two additional indications for its self-developed serplulimab injection, expanding its use in treating advanced esophageal and lung cancers across Europe.
"The marketing approval for the two new indications in the EU represents significant international recognition for Serplulimab and will benefit more global patients," Wenjie Zhang, Chairman of Henlius, said in a statement.
The approvals authorize serplulimab (HETRONIFLY) for the first-line treatment of adult patients with certain types of esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). The decision is based on data from two multi-center Phase 3 clinical trials that demonstrated significant improvements in clinical outcomes with an acceptable safety profile when serplulimab was added to standard chemotherapy.
This regulatory milestone opens a significant new market for Henlius, which has been actively expanding the global presence of its flagship immunotherapy drug. The global market for anti-PD-1 antibodies is projected to reach approximately $50.87 billion in 2025, according to data from IQVIA MIDAS, highlighting the substantial commercial opportunity for Henlius and its European partner, Intas Pharmaceuticals.
Expanded European Market Access
The new indications specifically cover serplulimab in combination with chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) with a PD-L1 combined positive score (CPS) of 5 or greater. The second approval is for its use with carboplatin and pemetrexed for the first-line treatment of adult patients with EGFR mutation-negative, ALK- or ROS1-negative unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC).
The authorization extends to all European Union member states, as well as the European Economic Area countries of Iceland, Liechtenstein, and Norway. This follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in March 2026.
Robust Clinical and Manufacturing Foundation
The approvals are supported by results from two randomized, double-blind, international Phase 3 clinical trials (ASTRUM-007 for ESCC and ASTRUM-005 for nsNSCLC). Both studies met their primary endpoints, showing that adding serplulimab to chemotherapy provided a statistically significant improvement in overall survival and progression-free survival compared to chemotherapy alone.
Henlius also previously secured EU Good Manufacturing Practice (GMP) certification for its production facilities, a critical prerequisite for supplying the European market. The company has an exclusive licensing agreement with Intas Pharmaceuticals for the commercialization of serplulimab in Europe and India, which will facilitate the drug's rollout.
The approval strengthens Henlius's position in the competitive immuno-oncology landscape and provides a new treatment option for European patients with these difficult-to-treat cancers. Investors will be watching for the commercial launch and initial sales figures in the European market as the next major catalyst.
This article is for informational purposes only and does not constitute investment advice.
