Serplulimab Injection 100 mg/10 mL Suppliers & Bulk Manufacturers

Available Forms: Concentrate vial (IV infusion)

Available Strengths: 100 mg/10 mL

Reference Brands: Hetronifly (EU), Hansizhuang (China) — Shanghai Henlius

Category: Oncology Cancer Care

Serplulimab (Hetronifly in the EU, Hansizhuang in China; Shanghai Henlius) is an anti-PD-1 antibody approved in the EU in February 2025 for extensive-stage small cell lung cancer with chemotherapy. It is approved in China and not yet in the US. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Serplulimab is a monoclonal antibody against PD-1, the "brake" receptor on T cells that tumours exploit to escape the immune system. Blocking PD-1 releases the brake so T cells can attack the cancer, the same mechanism as pembrolizumab and nivolumab.

Shanghai Henlius developed serplulimab, and China approved it in 2022. The European Commission approved it as Hetronifly in February 2025 for first-line treatment of extensive-stage small cell lung cancer together with carboplatin and etoposide, the first anti-PD-1 antibody approved in the EU for this cancer. It is given by intravenous infusion from 100 mg/10 mL vials. It is not approved in the US.

Sourcing and licensing notes. Serplulimab is patented and there is no biosimilar. Supply comes from Henlius and its regional partners, and the position differs by country, so we confirm registration status for each destination before quoting. It is a cold-chain product.