Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for IBI301 (rituximab, biosimilar) for Non-Hodgkin’s lymphoma

Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for IBI301 (rituximab, biosimilar) for Non-Hodgkin's lymphoma

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

Click here to read full press release/ article | Ref: Innovent | Image: Algosonline