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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: 27 May 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
  • No development reported Haematological malignancies; Solid tumours

Most Recent Events

  • 27 May 2025 Jiangsu Hengrui Medicine Co plans a phase I/II trial for Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater), in June 2025 (NCT06981988)
  • 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

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