Linperlisib - Shanghai Yingli Pharmaceutical
Alternative Names: HRS-3536; Intarel; YY-20394Latest Information Update: 28 Apr 2025
At a glance
- Originator Shanghai Yingli Pharmaceutical
- Developer Jiangsu Hengrui Medicine Co.; Shanghai Yingli Pharmaceutical
- Class Antineoplastics; Morpholines; Piperidines; Pyridines; Quinazolines; Small molecules; Sulfonamides
- Mechanism of Action Phosphatidylinositol 3 kinase delta inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Follicular lymphoma
- Phase III Peripheral T-cell lymphoma
- Phase II Chronic lymphocytic leukaemia
- Phase I/II Diffuse large B cell lymphoma; Non-Hodgkin's lymphoma
- No development reported Haematological malignancies; Solid tumours
Most Recent Events
- 28 Apr 2025 No recent reports of development identified for phase-I development in Solid-tumours(Late-stage disease, Second-line therapy or greater) in China (PO, Tablet)
- 01 Apr 2025 US FDA clears phase III registration trial design of Linperlisib for peripheral T-cell lymphoma
- 01 Apr 2025 Yingli Pharma announces successful End-of-Phase II meeting for overall development program and regulatory path with US FDA