InnoCare Pharma announced the approval of 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) by the Department of Health, the Hong Kong Special Administrative Region, China.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “The Hong Kong approval of tafasitamab and lenalidomide will not only provide access to eligible DLBCL patients in the region, but may also help patient access in the Greater Bay Area soon. Moving forward, we will accelerate the clinical trials of tafasitamab in China in the hopes of meeting more unmet medical needs.”

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).