HENLIUS (02696) has announced that the European Commission (EC) has recently approved two new indications for its self-developed Serplulimab injection, marketed as HANSIZHUANG® in China and HETRONIFLY® in the EU. The newly approved indications are: (1) Serplulimab in combination with fluoropyrimidine and platinum-based 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) ≥5; and (2) Serplulimab in combination 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). This approval means the two new indications for Serplulimab are now authorized in all European Union member states, as well as in Iceland, Liechtenstein, and Norway, which are part of the European Economic Area (EEA). The EC's decision is primarily based on two randomized, double-blind, multicenter Phase 3 clinical studies. Study results demonstrated that: (1) Serplulimab combined with chemotherapy (cisplatin and 5-fluorouracil) showed significant benefits compared to chemotherapy alone (cisplatin and 5-fluorouracil) in treating previously untreated locally advanced or metastatic ESCC, meeting the pre-specified primary endpoint criteria with a favorable safety and tolerability profile; and (2) Serplulimab combined with chemotherapy (carboplatin-pemetrexed) showed significant benefits compared to chemotherapy alone (carboplatin-pemetrexed) in treating previously untreated advanced nsNSCLC, also meeting the pre-specified primary endpoint criteria with good safety and tolerability. In December 2023, the group received several GMP certificates from the Dutch Health and Youth Care Inspectorate, indicating that the Serplulimab-related production lines comply with EU GMP standards. Furthermore, in March 2026, Serplulimab received a positive review opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval for the two new indications.