Dec. 31 Company Quick Takes: A first for BeiGene; plus MorphoSys, Junshi-CSPC, Acceleron-Fulcrum and Solasia-EditForce

First-ever China approval for homegrown BeiGene drug
China’s National Medical Products Administration approved anti-PD-1 mAb tislelizumab from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) to treat classical Hodgkin lymphoma in a third-line setting. The approval is the first in China from BeiGene’s in-house pipeline; it follows FDA’s accelerated approval in November of Brukinsa zanubrutinib to treat mantle cell lymphoma. NMPA is also reviewing an sNDA for tislelizumab as a second-line treatment for bladder cancer; the drug is not approved anywhere else in the world. BeiGene already markets three drugs in China under a partnership with the Celgene Corp. unit of Bristol-Myers Squibb Co. (NYSE:BMY).

MorphoSys seeking FDA approval of CD19 mAb
MorphoSys AG (Xetra:MOR; NASDAQ:MOR) submitted a BLA to FDA for tafasitamab to treat relapsed or refractory diffuse large B cell lymphoma. The anti-CD19 antibody has breakthrough therapy designation. ...