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Linperlisib - Shanghai Yingli Pharmaceutical

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Drug Profile

Linperlisib - Shanghai Yingli Pharmaceutical

Alternative Names: HRS-3536; Intarel; YY-20394

Latest Information Update: 14 Apr 2025

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - T-cell lymphoma; Chronic lymphocytic leukaemia; Follicular lymphoma
  • 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
  • Phase I Solid tumours
  • No development reported Haematological malignancies

Most Recent Events

  • 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
  • 01 Apr 2025 Yingli Pharma plans a phase III registrational trial for Peripheral T-cell lymphoma (Second-line therapy or greater) in USA (PO) in second quarter of 2025

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