Shots:

• The EMA’s CHMP positive opinion was provided in June and is the fifth product which received the EU approval for autoimmune diseases and tumor diseases
• The P-III study results of Abincio which involves 763 patients non-small cell lung cancer (NSCLC) patients and demonstrated the risk ratio of ORR vs original product- also presented at ESMO 2019
•  Aybintio is a mAb targeted for metastatic carcinoma of the colon or rectum- metastatic breast cancer- non–small cell lung cancer- advanced or metastatic renal cell cancer- epithelial ovarian- fallopian tube and primary peritoneal cancer- and cervical cancer. In Nov 2019 the approval review of BLA is submitted to the US FDA and is also accepted

Ref: Samsung Bioepsis | Image: Samsung Bioepis