On December 15, Cellular Biomedicine Group (hereinafter referred to as "CBMG") officially announced in Shanghai the amendment of the global collaboration and license agreement signed with Janssen Pharmaceuticals, Inc. (referred to as "Janssen"). According to the revised agreement, Janssen will have the right to commercialize the CD20-targeted chimeric antigen receptor T (CAR-T) cell products C-CAR039 and C-CAR066 in China. After achieving commercialization, Cellular Biomedicine Group will receive milestone payments.
At this stage, the Center for Drug Evaluation of the National Medical Products Administration has approvedThe IND application for C-CAR039. Currently, the Cellular Biomedicine Group team is conducting Phase Ib clinical trials. The clinical development and production capabilities of Cellular Biomedicine Group, combined with Janssen's global commercialization strengths, will maximize the potential of C-CAR039 and C-CAR066, providing innovative and life-changing therapeutic solutions for patients in China and globally. Regarding the amendment to this licensing agreement, Liu Bizuo, Chairman and CEO of Cellular Biomedicine Group, stated as follows.
Previously, Cellular Biomedicine Group (Shanghai) Ltd had alreadyGlobal Exclusive Collaboration with Janssen Announced in May. According to reports, both parties will jointly develop and commercialize the next-generation novel CAR-T cell therapy products C-CAR039 (targeting CD19/CD20) and C-CAR066 (targeting CD20) for the treatment of non-Hodgkin's lymphoma (NHL). In the same month, Cellular Biomedicine Group (Shanghai) Ltd received an upfront payment of $245 million from Janssen Pharmaceuticals to achieve certain predefined clinical development and regulatory submissions. During the commercialization process of the two drugs, Cellular Biomedicine Group will receive sales royalties from Janssen’s net sales.
It is reported that Cellular Biomedicine Group, a global innovative biopharmaceutical company dedicated to developing novel cell therapies, owns advanced research and development facilities in Rockville, Maryland.GMP facilities, and has collaborated with the production and R&D center located in Shanghai to conduct multiple clinical studies in fields such as hematological tumors and solid tumors.
Among them,C-CAR039 is a novel bispecific CAR-T product targeting both CD19 and CD20. It has received IND approval from the U.S. FDA, as well as Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track status for the treatment of relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) patients. A Phase 1b trial being conducted in the United States is currently evaluating the efficacy of C-CAR039 in treating r/r DLBCL patients. C-CAR066 is an optimized novel CD20-targeted CAR-T product that has also received IND approval from the U.S. FDA and is currently in a Phase 1b study in the United States for r/r DLBCL patients, including those who have failed prior CD19 CAR-T therapy.
According to the latest data released by Cellular Biomedicine Group (Shanghai) Ltd, both products observed excellent response rates, durability of response, and good safety in clinical research for drug development. In terms of durability of response, after...With a median follow-up period of approximately 30 months, achieving such a remission rate is indeed impressive, demonstrating best-in-class potential and is expected to bring excellent therapeutic effects to patients.
