China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Department of Health in Hong Kong for its tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Drug Profile and Global Approvals
Tafasitamab is an Fc-enhanced, humanised, anti-CD19 monoclonal antibody. It is already approved in the US (branded Monjuvi) and Europe (branded Minjuvi) for DLBCL in combination with lenalidomide in patients not eligible for stem-cell transplant. InnoCare has secured early access for tafasitamab + lenalidomide via Hainan’s Boao Lecheng International Medical Tourism Pilot Zone for its use in combination with lenalidomide in DLBCL.
Collaboration and Clinical Trials
In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. InnoCare obtained approval to start a Phase II clinical trial assessing a combination of orelabrutinib with tafasitamab and lenalidomide in patients with relapsed/refractory (r/r) non-Hodgkin’s lymphoma (nHL) last week and is carrying out a Phase II regulatory study for the tafasitamab/lenalidomide combo in DLBCL.
Future Prospects and Strategic Implications
The market approval in Hong Kong marks a significant milestone for InnoCare Pharma in expanding its presence in the Greater China region. By leveraging its innovative drug development capabilities and strategic collaborations, InnoCare aims to address significant unmet medical needs in hematology and oncology, improving patient outcomes in conditions such as DLBCL.-Fineline Info & Tech
