Competition in the PI3K inhibitor market has increased

A few days ago, Incyte announced that the FDA has accepted a new generation of phosphatidylinositol 3-kinase delta (PI3K delta) inhibitor parsaclisib for the treatment of relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma New Drug Application (NDA) for Type 3 Non-Hodgkin’s Lymphoma (MCL)

The submission of the parsaclisib NDA is based on positive data from Phase 2 studies CITADEL-203 (for relapsed or refractory FL), CITADEL-204 (for MZL) and CITADEL-205 (for relapsed or refractory MCL)

Parsaclisib is a potent, highly selective, new-generation phosphatidylinositol 3-kinase delta (PI3K delta) oral inhibitor developed by Incyte

In December 2018, Innovent and Incyte reached a strategic cooperation and exclusive licensing agreement, obtaining the latter's rights to develop and commercialize three drugs including parsaclisib in Greater China

Phosphatidylinositol 3-kinase (PI3K) is an intracellular lipid phosphokinase.

At present, the FDA has approved 5 PI3K inhibitors, as shown in the table below

Zydelig is the first oral, selective PI3Kδ inhibitor on the market.

Aliqopa is a pan-type I phosphatidylinositol-3-kinase (PI3K) inhibitor.

Copiktra is the first PI3K-δ and PI3K-γ dual-effect inhibitor approved by the FDA.

Piqray is the first and only treatment specifically approved for the treatment of advanced breast cancer with PIK3CA mutations in tumors.

Ukoniq is the first and only oral, once-daily, dual inhibitor of PI3K-δ and casein kinase 1-ε (CK1-ε) approved for the treatment of relapsed/refractory MZL and FL.

In addition, Linperlisib (Linperlisib, YY-20394), a new-generation PI3Kδ inhibitor developed by Yingli Pharmaceuticals, has also been submitted to the domestic market for the treatment of relapsed or refractory FL that has previously received second-line or more systemic systemic treatment.