Shots:

• The NDA is based on two P-III studies evaluating the safety- efficacy & PK of IBI301 vs MabThera/Rituxan (rituximab) in patients with DLBCL & CD20-positive B-cell lymphoma respectively
•  The two P-III studies resulting in meeting its 1EPs demonstrating the bio-similarity b/w IBI301 and branded rituximab
• IBI301 is a biosimilar of rituximab targeting CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC)- co-developed by Lilly and Innovent for NHL and other diseases

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Ref: Innovent | Image: Eli Lilly