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Development, GMP manufacturing, preclinical, clinical,
global regulatory.

Porton Advanced delivers the biopharma industry’s most comprehensive IND acceleration service, combining process development, GMP manufacturing, pre-clinical services, clinical services, and global regulatory strategy into a single integrated solution.
  • 18+ IND Approvals
    NMPA (12), FDA (4), MedSafe (1)
  • 100% Success Rate
    Zero-deficiency submissions
  • Complex Modalities
    CAR-T, NK, TIL, TCR-T, mRNA therapies
Global Pioneering Programs
  • World’s first mRNA-based TCR-T cell therapy targeting HBV
  • World’s first autologous natural TIL cell therapy without lymphodepletion or IL-2 injections
  • World’s first CAR-T therapy targeting EpCAM to receive IND approvals (NMPA & FDA)
  • World’s first CAR-T therapy targeting B7-H3 for glioblastoma with IND approvals (NMPA & FDA)
  • Two FDA Orphan Drug Designations for cell therapy programs
China Pioneering Programs
  • China’s first CAR-T therapy approved for recurrent & refractory ovarian cancer
  • China’s first CAR-T therapy targeting NKG2DL solid tumors
  • China’s first gene-modified mesenchymal stem cell (MSC) therapy
  • China’s first FDA-approved IND for non-gene-modified allogeneic peripheral blood NK cell therapy
  • China’s first novel multi-chain CAR-T therapy targeting the tumor microenvironment

18 Global IND Approvals at a Glance

Modality Indication Authorities Date
TIL Advanced solid tumor NMPA 2022
CAR-T Advanced solid tumor NMPA 2022
CAR-T Recurrent refractory ovarian cancer NMPA 2022
mRNA vaccine C0V1D-19 MedSafe 2022
TIL Advanced recurrent and metastatic cervical cancer NMPA 2023
mRNA vaccine COVID-19 FDA 2023
CAR-T NKG2DL-positive advanced solid tumor NMPA 2023
CAR-T Mesothelin-positive advanced ovarian cancer NMPA 2023
CAR-T Malignant glioma FDA 2023
NK Ovarian Cancer FDA 2024
CAR-T Malignant glioma NMPA 2024
CAR-T Advanced Gastric Cancer NMPA 2024
CAR-T Advanced Gastric Cancer FDA 2024
CAR-T Diabetes mellitus type 2 NMPA 2024
OV Advanced solid tumors NMPA 2024
mRNA TCR-T Hepatitis B virus-related hepatocellular carcinoma NMPA 2024
CAR-T Epithelial advanced solid tumors FDA 2024
Dual-targeting CAR-T  Glioblastoma NMPA  2025

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