East China Medicine and YiMiao ShenZhou Strike Over RMB 1.07 Billion CAR-T Collaboration for IM19 Injection
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
Imunopharm
Developer of Gene and Cell Therapy Technologies
Today (August 4), Huadong Medicine and Beijing Yimiaoshenzhou Medical Techology Co., Ltd. announced that the two partiesIM19 Chimeric Antigen Receptor T-Cell Injection, an autologous CAR-T candidate product targeting CD19(hereinafter referred to as "IM19 Injection") to reach a commercialization cooperation in mainland China.According to the terms of the agreement, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. will receive an upfront payment of 125 million RMB and is entitled to receive registration and sales milestone payments of up to 950 million RMB.。Yimiao Shenzhou will continue to be responsible for the development, registration, and production of IM19 injection in mainland China.
IM19 Injection is the first CAR-T cell therapy product independently developed by Beijing Yimiaoshenzhou Medical Technology Co., Ltd. It has successively obtained clinical trial approval notices for three indications from the National Medical Products Administration (NMPA) of China, namely, relapsed or refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma, all of which have entered the registration clinical research stage. Among them,The Phase 2 clinical trial (confirmatory clinical trial) for the end-line treatment of diffuse large B-cell lymphoma is nearing completion, with positive clinical efficacy and safety data. The marketing authorization application is expected to be submitted in the fourth quarter of 2024.Based on this cooperation, Huadong Medicine will obtain the exclusive commercial rights of IM19 injection in mainland China.
[1] Huadong Medicine and Beijing Yimiaoshenzhou Medical Technology Co., Ltd. Announce Commercial Collaboration on CD19 Autologous CAR-T Product IM19 Injection.Retrieved Aug 4 , 2024, from https://mp.weixin.qq.com/s/W571ezv4T2dRFxGL_d_IKg
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