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September 6, 2022

China NMPA grants priority review for InnoCare’s orelabrutinib for lymphoma

The supplemental New Drug Application is based on findings from a Phase II trial of orelabrutinib to treat R/R MZL.

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma’s orelabrutinib to treat relapsed or refractory marginal zone lymphoma (R/R MZL).

The CDE accepted the supplemental New Drug Application (sNDA) of orelabrutinib for R/R MZL on 12 August this year. 

This sNDA is based on findings from an open, multicentre Phase II clinical trial which assessed the safety and efficacy of orelabrutinib to treat R/R MZL.

A highly selective inhibitor of bruton tyrosine kinase (BTK), orelabrutinib is developed by the company to treat autoimmune ailments and cancers.

The therapy obtained conditional approval from the NMPA for two indications in December 2020.

Orelabrutinib is indicated to treat R/R chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL) as well as R/R mantle cell lymphoma (MCL). 

Last year, it was included in the National Reimbursement Drug list to benefit several patients with lymphoma.

Currently, multicentre, multi-indication trials of orelabrutinib as a single agent or along with other therapies are progressing in the US and China.

Additionally, it is being analysed in international Phase II trials to treat multiple sclerosis as well as in SLE, primary immune thrombocytopenia and neuromyelitis optica spectrum disorder trials in China.

Orelabrutinib has also received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) to treat r/r MCL.

InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “This is the third indication of orelabrutinib granted priority review. 

“There are unmet medical needs for patients with R/R MZL. We hope orelabrutinib can bring better treatment options to benefit patients with R/R MZL.”

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