Procuring Henlius Serplulimab (Hansizhuang® PD-1): Clinical Breakthroughs, Top Shanghai Hospital Teams & International Buyer's Guide

Procuring Henlius Serplulimab (Hansizhuang® PD-1): Clinical Breakthroughs, Top Shanghai Hospital Teams & International Buyer's Guide

Immune checkpoint inhibitors—specifically monoclonal antibodies targeting the programmed cell death protein 1 (PD-1)—have transformed modern medical oncology. While first-generation Western PD-1 inhibitors established the paradigm, aggressive malignancies such as Extensive-Stage Small Cell Lung Cancer (ES-SCLC) historically remained resistant, leaving patients with limited chemotherapy alternatives and severe financial toxicity. Headquartered in Shanghai, Henlius Biotech (复宏汉霖) broke global clinical ground with Serplulimab (斯鲁利单抗 / H 药 / Hansizhuang®), the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of ES-SCLC.

For international hospital groups, oncology clinic networks, national tender boards, and pharmaceutical distributors seeking to source high-efficacy, EU-GMP-certified biologics from China, China Medical Concierge – Shanghai (CMCS) acts as your authoritative on-ground healthcare navigation liaison in Shanghai.

1. Clinical Innovations & Global Landmark Evidence

Serplulimab is a recombinant humanized IgG4 monoclonal antibody engineered for high affinity, robust tumor microenvironment penetration, and favorable immunogenicity profiles:

World's First Anti-PD-1 Approved for First-Line ES-SCLC

  • The Pivotal *JAMA* ASTRUM-005 Trial: The global, multicenter Phase 3 clinical trial (ASTRUM-005), published in JAMA (Journal of the American Medical Association), enrolled patients across China, Europe, and Asia. Serplulimab combined with chemotherapy demonstrated significant, unprecedented overall survival (OS) improvements in first-line ES-SCLC, achieving a median OS of 15.4 months versus 10.9 months with chemotherapy alone, fundamentally altering global treatment guidelines.

Broad Spectrum of Approved Oncology Indications

  • Extensive-Stage Small Cell Lung Cancer (ES-SCLC): First-line combination therapy.
  • Advanced Esophageal Squamous Cell Carcinoma (ESCC): First-line combination with chemotherapy, exhibiting superior progression-free survival (PFS) in squamous histology.
  • Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC): First-line regimen providing durable objective response rates.
  • MSI-H / dMMR Solid Tumors: Broad tissue-agnostic indication for microsatellite instability-high advanced solid malignancies.

Global Approvals & EU EC Marketing Authorization

  • Serplulimab has received marketing authorization from the European Commission (EC) and has been submitted to or authorized across more than 40 countries and territories worldwide, establishing Chinese innovative biologics as mainstream standards of care in Europe and emerging markets.

2. Premier Shanghai Hospitals & Oncology Teams Utilizing Serplulimab

Shanghai houses premier national clinical research centers for thoracic and digestive oncology where Serplulimab underwent landmark clinical investigation and routine adoption:

  • Shanghai Chest Hospital (Shanghai Jiao Tong University)
    Department of Medical Oncology & Thoracic Oncology: A premier global cancer center for lung cancer clinical trials. The medical oncology faculty served as lead national investigators for Serplulimab’s pivotal thoracic trials, establishing routine clinical protocols for first-line ES-SCLC and complex squamous cell carcinomas.
  • Shanghai Ruijin Hospital (Shanghai Jiao Tong University School of Medicine)
    Department of Medical Oncology: Internationally acclaimed for multidisciplinary cancer care, biomarker-driven immunotherapy selection, and immune-related adverse event (irAE) management.
  • Shanghai Zhongshan Hospital (Fudan University)
    Department of Medical Oncology: Leading clinical teams evaluating Serplulimab across GI tract malignancies, including esophageal squamous carcinomas and advanced gastroesophageal junction tumors.

3. Procurement & Distribution Advantages for Overseas Buyers

  1. Unmatched Clinical Value & Health Economics: Serplulimab offers comparable or superior overall survival outcomes compared to premium Western PD-1/PD-L1 inhibitors at a substantially more favorable health-economic cost, unlocking higher procurement feasibility for public reimbursement systems and private cancer clinics.
  2. EU-GMP Certified Commercial Biomanufacturing: Manufactured at Henlius’s commercial biologics facility in Songjiang, Shanghai (with continuous bioreactor capacities exceeding 24,000L), certified under stringent European Union GMP and China NMPA GMP standards, ensuring sterile batch consistency and robust export supply.
  3. Validated Global Cold-Chain Architecture: Strict 2°C–8°C validated logistics protocols ensuring product stability across long-haul international air-freight corridors.
  4. Expanding Overseas Reimbursement: With European Commission authorization, the biologic is eligible for hospital listing, tender participation, and HTA (Health Technology Assessment) reviews across multiple international jurisdictions.

4. How CMCS Assists Overseas Buyers with Commercial Navigation

Procuring prescription biological pharmaceuticals across borders demands stringent compliance with international pharmaceutical trade regulations, Good Distribution Practice (GDP), and cold-chain integrity. CMCS provides an authoritative bridge in Shanghai:

  • Clinical Research Review & Key Opinion Leader (KOL) Dialogue: We coordinate academic peer exchanges for overseas medical directors and oncologists with Shanghai investigators (e.g., at Shanghai Chest Hospital and Ruijin), reviewing clinical trial cohorts, real-world dosing regimens, and biomarker stratification data.
  • Songjiang Biomanufacturing Facility Audits: CMCS coordinates on-site technical audits for international procurement delegations at Henlius’s Songjiang commercial biomanufacturing campus, inspecting single-use bioreactors, downstream chromatographic purification units, and automated vial fill-finish isolators.
  • Direct Commercial & Tender Liaison: We connect international buyers, hospital consortia, and pharmaceutical distributors directly with Henlius’s global commercial leadership and licensed export pharmaceutical entities to negotiate direct-from-manufacturer supply contracts, distributor licensing, and tender support.
  • Licensed Pharmaceutical Logistics & Special Export Documentation: We assist in coordinating compliant cold-chain customs clearance for Category D biopharmaceutical products through the Shanghai Free Trade Zone, aligning with licensed pharmaceutical freight forwarders to ensure uninterrupted 2°C–8°C data-logged transit.

Strict Regulatory & Compliance Boundary Notice

China Medical Concierge – Shanghai (CMCS) is an independent healthcare management and medical procurement navigation consultancy based in Shanghai. CMCS is NOT a licensed pharmaceutical trading company, pharmaceutical distributor, or pharmacy, and does NOT sell, distribute, export, or dispense prescription medications directly. Serplulimab is a prescription biologic requiring licensed pharma-to-pharma transactions, valid Ministry of Health import licenses, and specialized pharmaceutical cold-chain handling. CMCS strictly facilitates professional on-ground technical audits, clinical exchanges, and direct commercial introductions to certified pharmaceutical manufacturers and their licensed export partners. CMCS does not support personal drug mailing or unlicensed cross-border pharmaceutical transfers.

Initiate a Biopharmaceutical Procurement Consultation in Shanghai

To schedule an academic clinical review in Shanghai, coordinate a technical audit of Henlius's Songjiang biomanufacturing facility, or receive technical dossiers and commercial partnership information for Serplulimab, please contact our international liaison office:

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