Congratulations! FAB Supports China Approval of Tafasitamab, Self-Developed by InnoCare Biopharma

On May 21st, the NMPA website announced the approval of InnoCare’s CD19 targeting monoclonal antibody Tafasitamab for marketing in China. It is indicated in combination with lenalidomide for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) who are ineligible for autologous stem cell transplantation.

FAB, as China’s leading medical imaging CRO, provided comprehensive Independent Review Committee (IRC) services for the Phase II clinical study of this drug.

Source: NMPA

Tafasitamab is a humanized monoclonal antibody targeting CD19. It contains a uniquely engineered Fc domain that significantly enhances antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), mediating the lysis of B-cell malignancies through apoptosis and immune effector mechanisms.

At the 2024 EHA conference, InnoCare presented data from a Phase II study (NCT05552937) of Tafasitamab combined with lenalidomide in relapsed or refractory DLBCL. This single-arm, open-label, multicenter Phase II study evaluated the safety and efficacy of Tafasitamab plus lenalidomide in r/r DLBCL patients.

The data demonstrated that Tafasitamab combined with lenalidomide exhibited favorable tolerability and efficacy in the Chinese population, with preliminary efficacy and safety profiles generally consistent with the L-MIND study.

As of January 29, 2024, the Independent Review Committee (IRC)-assessed objective response rate (ORR) was 73.1%, with a complete response (CR) rate of 32.7% and a partial response (PR) rate of 40.4%. Investigator-assessed ORR was 69.2%, with both CR and PR rates at 34.6%.

Source: InnoCare

As a leader in China's imaging CRO sector, FAB is deeply honored to have been extensively involved in this project. We provided professional independent central imaging and central tumor assessment services, with our service quality and deliverables earning high praise from the Sponsor.

We consistently prioritize client needs, leveraging our professional expertise and execution capabilities to deliver comprehensive support—from image acquisition protocol design and independent review charter development to customized review system implementation—ensuring efficient project advancement and strict adherence to client milestone requirements.

Throughout the project lifecycle, from initiation to closure, FAB maintained frequent communication and close collaboration with all stakeholders. We provided systematic and thorough training to study sites and reviewers on trial-specific requirements and assessment criteria. For the critical aspect of image quality control management, we established stringent quality standards and processes to ensure data accuracy and consistency. Upon identifying image quality issues, immediate feedback was provided, followed by rapid resolution through efficient communication. FAB proactively scheduled review timelines and coordinated expert availability, ensuring all assessments were completed on time with uncompromised quality under the principle of scientific rigor. During the NMPA inspection, FAB demonstrated exceptional responsibility and professionalism, providing meticulous responses to inspectors' queries in full support of the Sponsor, ultimately facilitating successful regulatory approval.

With deep expertise in clinical imaging assessment, FAB continues to lead the industry through professional excellence. To date, we have supported over 320 clinical imaging assessment projects, with 58 advanced to NDA submission. The cumulative number of approvals supported has reached 39! Notably, in the first half of this year alone, FAB has facilitated the market entry of 8 novel drugs—outperforming last year's full-year total! The approval of Tafasitamab marks a significant milestone in lymphoma treatment: it is not only China's first approved CD19-targeted monoclonal antibody for r/r DLBCL, but also the sixth innovative drug project successfully delivered by FAB in the lymphoma field.

FAB extends warm congratulations to InnoCare on this major achievement! We look forward to continuing our close collaboration in future partnerships, jointly advancing innovative drug development to bring transformative therapies to patients worldwide.