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. 

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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). 

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.”

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.

Discover the Impact