BEIJING, China. Jan. 22, 2024 - InnoCare (HKEX: 09969; SSE:688428) today announced that tafasitamab (Minjuvi®) in combination with lenalidomide has been recently approved by the Medical Products Administration of Guangdong Province, under the early access program in Guangdong-Hong Kong-Macao Greater Bay Area (“Greater Bay Area” for short), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient.

The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access to tafasitamab in the Greater Bay Area. To fulfil the mission ‘Science drives innovation for the benefit of patients’, InnoCare will accelerate the registrational trial of tafasitamab and lenalidomide in mainland China in the hopes of addressing the unmet medical needs.”

Patient enrollment of the registrational trial of tafasitamab in combination with lenalidomide for the treatment of r/r DLBCL was completed in China. InnoCare expects to submit the biologics license application (BLA) in the second quarter of 2024.

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 for the treatment of eligible DLBCL patients in Hong Kong, and under the early access program in Boao Lecheng International Medical Tourism Pilot Zone as well as Greater Bay Area.

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 the ASCT.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHLs[1].

Source:https://www.innocarepharma.com/en/news/activity/en020240122