BeiGene’s Tislelizumab Receives NMPA’s Priority Review to sNDA for Urothelial Carcinoma in China

BeiGene’s Tislelizumab Receives NMPA’s Priority Review to sNDA for Urothelial Carcinoma in China

Shots:

  • The sNDA follows clinical, non-clinical, chemistry, manufacturing and controls (CMC) data and P-II study results assessing Tislelizumab in 113 patients with LA or metastatic UC prior treated with PD-L1+ in China & South Korea
  • The NMPA granted second PR designation to Tislelizumab following the two PR designation of Zanubrutinib for r/r MCL and r/r CLL or SLL in China
  • Tislelizumab (BGB-A317) is a Fc-engineered anti-PD-1 Ab, being developed as monothx. & combination therapy for both solid and hematologic cancers and has received NMPA’s PR for r/r cHL in Nov’18 with its accepted NDA & sNDA filing in Aug’2018 & May’2019 & by NMPA respectively

Click here to read full press release/ article | Ref: BeiGene | Image: Quebec Daily Examiner