Integrated IND-enabling Study Service

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

NumberModalitiyIndicationAuthoritiesDate
1TILAdvanced solid tumorNMPA2022
2CAR-TAdvanced solid tumorNMPA2022
3CAR-TRecurrent refractory ovarian cancerNMPA2022
4mRNA vaccineCOVID-19MEDSAFE2022
5TILAdvanced recurrent and metastatic cervical cancerNMPA2023
6mRNA vaccineCOVID-19FDA2023
7CAR-TNKG2DL-positive advanced solid tumorNMPA2023
8CAR-TMesothelin-positive advanced ovarian cancerNMPA2023
9CAR-TMalignant gliomaFDA2023
10NKOvarian CancerFDA2024
11CAR-TMalignant gliomaNMPA2024
12CAR-TAdvanced Gastric CancerNMPA2024
13CAR-TAdvanced Gastric CancerFDA2024
14CAR-TDiabetes mellitus type 2NMPA2024
15OVAdvanced solid tumorsNMPA2024
16mRNA TCR-THepatitis B virus-related hepatocellular carcinomaNMPA2024
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