May 31 Company Quick Takes: NMPA accepts two BeiGene applications, approves Hengrui's PD-1 inhibitor; and more
NMPA accepts applications for BeiGene's tislelizumab, Abraxane
China's National Medical Products Administration has accepted an sNDA from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) for tislelizumab to treat previously treated, locally advanced or metastatic urothelial carcinoma. The anti-PD-1 mAb is also under review in China for relapsed/refractory classical Hodgkin lymphoma. NMPA accepted BeiGene's supplemental import drug application for Abraxane paclitaxel in combination with gemcitabine for first-line treatment of metastatic pancreatic cancer. BeiGene markets Abraxane in China for breast cancer under a license from Celgene Corp. (NASDAQ:CELG).
Hengrui PD-1 inhibitor approved for Hodgkin lymphoma ...