RE: Cavendish Flash on sovleplenib10 Jul 2024 11:38
The company did give some sales values of current ITP treatments (there are other indications included, but these ran to $5bn+).
Global development would follow a rough timetable:
Phase 1 complete 2024
Agreed design of reg study mid 25 (and confirm partner)
Complete registration end 26, NDA submission mid 27, approval mid 28.
Dr Su said ITP was getting more crowded, but he believes HCM is ahead in China and has a strong durable response. Pts survive for a long time under treatment, so I can see the argument that Sovlep will be tried by many pts and used by 50% for some time until they need to try another treatment. The Cavendish analyst asked about a recent Takeda ITP announcement (not a SYK inhibitor), and Dr Shi questioned the high number of discontinued pts. They did not seem particularly concerned about new competitor products and may gain a useful head start in China.