Denne er fra mars i år , men viser at når kinserne bestemmer seg så skjer ting med lynets hastighet og stor besluttsomhet:
https://endpts.com/after-a-makeover-and-hiring-spree-chinas-drug-agency-is-romping-and-stomping-on-new-reviews-and-approvals/
“Each IND took an average of 120 working days to evaluate, 1.09 times the period required by law — a drastic improvement from, say, 2012, when records show that almost half of the applications would take longer than 400 days to process.”
“The CDE also ramped up the priority review system, which was launched in 2016. By their count, first rounds for INDs, NDAs and ANDAs took an average of 39, 59 and 81 working days once they were accepted for priority review.”
“The CDE’s 110 priority review approvals translated to 57 drugs, and 50 of those were approved in 2017. Overseas pharmas won big: Regeneron’s Eylea, AbbVie’ Humira, Incyte’s Jakafi and Celgene’s Vidaza (to be marketed by partner BeiGene) were among those approved through the priority review track.”
Jeg er sikker på at de forandringen som nå skjer i Kina gjør Amphinex for GGK svært interessant for en asiatisk partner. Den potensielle verdien blir nå svært mye høyere enn for bare noen år siden.
Følgende er basert på kvalifisert synsing, men siden Amphinex er mer basert på et fysisk prinsipp så blir det veldig enkelt å argumentere for mtp på populasjon. Trolig vil en NDA skli rett gjennom CFDA.