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Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia

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Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia

Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia

Shots:

  • The acceptance and Priority Review designation were based on the P-II pivotal study to evaluate the efficacy and safety of olverembatinib in 144 patients with CML-CP who are resistant & intolerant to first- and second-generation TKIs
  • The results showed that olverembatinib can significantly improve the EFS vs control group and has met the pre-specified superiority criteria. The results will be presented at an upcoming academic conference
  • Olverembatinib is a third-generation BCR-ABL inhibitor that is developed by Ascentage with support from the National Major New Drug Discovery & Manufacturing program which will be co-commercialized in China by both companies. The therapy has received ODD from the US FDA & EMA while FTD from the US FDA

Ref: PRNewswire | Image: Innovent

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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