The National Medical Products Administration (NMPA) website indicates that linperlisib, a Category 1 anti-tumor drug, has been conditionally approved in China. The drug is developed by US-based Yingli Pharma, a firm focused on developing products for both the China and US markets. The intended indication for linperlisib is recurrent/refractory (R/R) follicular lymphoma (FL). Hengrui Medicine will assist in the commercialization of the drug in China.
Linperlisib Profile
Linperlisib is a highly selective and potent PI3Kδ inhibitor, targeting a validated pathway in lymphomas due to its critical role in cell proliferation and survival. The latest results from the Phase II clinical study of linperlisib in China for R/R FL showed an overall response rate (ORR) of 79.8%, a disease control rate (DCR) of 96.6%, and a 12-month overall survival (OS) of 91.4%. The median time to remission (mTTR) was 1.9 months, the median progression-free survival (mPFS) was 13.4 months, and the median duration of remission (mDOR) was 12.3 months. In terms of safety, most adverse reactions were controllable, and the drug was generally well tolerated. Administered orally once per day, linperlisib offers good efficiency, safety, and medication compliance.
Regulatory Milestones
Linperlisib was awarded Breakthrough Therapy status by the NMPA in 2020. The drug also holds Orphan Drug Designations from the US FDA for follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and T cell lymphoma. These designations highlight the drug’s potential to address significant unmet medical needs in these conditions.-Fineline Info & Tech
