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
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com