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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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