赛诺菲BTKi有望年内获批SPMS，关注25H2PPMS数据读出

Investment Rating - The industry rating is neutral, indicating that the overall return is expected to be between -5% and 5% relative to the CSI 300 index over the next six months [7][11]. Core Insights - Sanofi's BTK inhibitor tolebrutinib has received FDA priority review for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), with a PDUFA date set for September 28, 2025. This could potentially make it the first brain-penetrating BTK inhibitor for nrSPMS globally [3][4]. - The application for tolebrutinib is based on three Phase 3 studies, with the HERCULES study showing a 31% delay in the time to confirmed disability progression (CDP) compared to placebo. Safety data indicates that 4.1% of participants experienced elevated liver enzymes, with manageable liver toxicity [3][4]. - The market for PMS (progressive multiple sclerosis) shows significant unmet needs, with approximately 1.27 million MS patients in Europe and the US, where RMS, SPMS, and PPMS account for 72%, 18%, and 10% respectively. Current treatment options for PMS are limited [5][8]. Summary by Sections Company Ratings - The report suggests a focus on Sanofi and Roche's BTK inhibitors regarding regulatory decisions and data readouts, as well as the global Phase 3 clinical progress of AbbVie's drug [5][8]. Clinical Trials and Research - Tolebrutinib's Phase 3 studies were previously halted due to liver toxicity concerns but resumed after protocol adjustments. The HERCULES study achieved its primary endpoint, while the GEMINI studies did not [4][5]. - The upcoming data readout for Roche's Fenebrutinib in treating PPMS is expected in the second half of 2025, while Sanofi's PERSEUS study for PPMS is also anticipated [5][8].