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Track Records

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
    IND-enabling Services for
    Diversified Modalities
    CAR-T, NK, TIL, TCR-T, MSC, and mRNA 
We take immense pride in partnering with pharmaceutical companies at the forefront of advanced therapy medicinal products. Together, we are dedicated to delivering excellence that drives innovation and accelerates candidate drugs into clinics.
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

Track record of 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
MSC 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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