Porton Advanced created, and now exclusively offers, our own integrated IND-enabling study service. We lead IND-enabling studies in areas of process development and GMP manufacturing, pre-clinical services, clinical services, and regulatory affairs. We have successfully assisted our Chinese clients in obtaining 11 NMPA IND approvals, 4 FDA IND approvals, and 1 MedSafe IND approval.
Track Records
Number | Modalitiy | Indication | Authorities | Date |
1 | TIL | Advanced solid tumor | NMPA | 2022 |
2 | CAR-T | Advanced solid tumor | NMPA | 2022 |
3 | CAR-T | Recurrent refractory ovarian cancer | NMPA | 2022 |
4 | mRNA vaccine | COVID-19 | MEDSAFE | 2022 |
5 | TIL | Advanced recurrent and metastatic cervical cancer | NMPA | 2023 |
6 | mRNA vaccine | COVID-19 | FDA | 2023 |
7 | CAR-T | NKG2DL-positive advanced solid tumor | NMPA | 2023 |
8 | CAR-T | Mesothelin-positive advanced ovarian cancer | NMPA | 2023 |
9 | CAR-T | Malignant glioma | FDA | 2023 |
10 | NK | Ovarian Cancer | FDA | 2024 |
11 | CAR-T | Malignant glioma | NMPA | 2024 |
12 | CAR-T | Advanced Gastric Cancer | NMPA | 2024 |
13 | CAR-T | Advanced Gastric Cancer | FDA | 2024 |
14 | CAR-T | Diabetes mellitus type 2 | NMPA | 2024 |
15 | OV | Advanced solid tumors | NMPA | 2024 |
16 | mRNA TCR-T | Hepatitis B virus-related hepatocellular carcinoma | NMPA | 2024 |