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June 11, 2021

LoA Update: Shanghai Fosun’s FN-1501 approval likelihood in refractory AML drop by five points, relapsed AML by seven points after Phase I update

Shanghai Fosun Pharmaceutical’s asset FN-1501 had its Likelihood of Approval (LoA) drop by five points and seven points in refractory and relapsed acute myeloid leukaemia (AML), respectively, on the back of a Phase I trial update.

By Reynald Castañeda

Shanghai Fosun Pharmaceutical’s asset FN-1501 had its Likelihood of Approval (LoA) drop by five points and seven points in refractory and relapsed acute myeloid leukaemia (AML), respectively, on the back of a Phase I trial update. On 24 May, the trial’s ClinicalTrials.gov entry was updated to show its primary completion was changed from June 2020 to September 2021.

The 33-patient Phase I basket trial investigating FN-1501 monotherapy in advanced solid tumours as well as in refractory or relapsed (AML) patients. The trial has recruited its first patient in July 2018. It has a primary endpoint investigating FN-1501’s safety profile and maximum tolerated dose.

FN-1501 previously had an LoA of 11% in refractory AML, dropping to 6%, as of 5 June. The asset had an LoA of 14% in relapsed AML patients, decreasing to 7%. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. LoA is calculated by compounding the Phase Transition Success Rate (PTSR) at each stage the drug is yet to progress through. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. Both LoA and PTSR can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

Shanghai Fosun has a market cap of $24.09bn.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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