BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

December 31, 2019 Auto Bot approval, BeiGene, NMPA, receives, regulatory, Tislelizumab, Treatment 0

Shots:

  • The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months
  • The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also received NMPA’s Priority Review while BeiGene is currently working with BI for its commercial supply to launch in China
  • Tislelizumab (BGB-A317, 200mg, IV) is a humanized IgG4 anti–PD-1 mAb targeted to minimize binding to FcγR on macrophages and is been evaluated as a monothx and in combination to treat multiple solid tumor and hematologic cancers with 15 registration-enabling trials conducted in China and globally, including 11 P-III trials and 4 pivotal P-II trials

Click here to read full press release/ article | Ref: BeiGene | Image: Twitter