Huadong Medicine and Imunopharm Announce Commercialization Partnership for CD19-Directed Autologous CAR-T Product IM19 Injection

On August 4, 2024, Huadong Medicine Co., Ltd. (hereinafter referred to as "Huadong Medicine") announced that its wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., has reached a commercial collaboration in mainland China with Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (hereinafter referred to as "Yimiao Shenzhou"), an innovative company primarily focused on the research and development of CAR-T cell therapies for hematological malignancies and solid tumors. The collaboration focuses on IM19 Chimeric Antigen Receptor T-Cell Injection (hereinafter referred to as "IM19 Injection"), Yimiao Shenzhou's autologous CAR-T candidate product targeting CD19.

IM19 Injection, as the leading pipeline product of Beijing Yimiaoshenzhou Medical Technology Co., Ltd., is currently undergoing clinical research in China for three indications: diffuse large B-cell lymphoma, mantle cell lymphoma, and acute B lymphoblastic leukemia. The study focusing on end-stage treatment for diffuse large B-cell lymphoma is expected to complete Phase II clinical trials (confirmatory clinical trial) by 2024. Based on this collaboration, Huadong Medicine Co., Ltd. will obtain exclusive commercial rights for IM19 Injection in mainland China.

Dr. He Ting, Founder, Chairman, and Chief Executive Officer of Beijing Yimiaoshenzhou Medical Technology Co., Ltd., stated: "We are highly honored to establish a partnership with Huadong Medicine, marking a solid step forward in the commercialization of our self-developed CAR-T drug. Huadong Medicine has extensive commercialization experience in mainland China and strategic goals to become a leading pharmaceutical company in the field of oncology treatment, laying a strong foundation for both parties to build a powerful and mutually beneficial strategic partnership. We are confident that through this collaboration, leveraging the leading product advantages of IM19 injection and Huadong Medicine's robust commercialization capabilities, we can further accelerate the commercialization process of IM19 injection in China, effectively addressing the significant clinical demand for B-cell hematological malignancies in China."

Lü Liang, Chairman and General Manager of Huadong Medicine, stated: "Beijing Yimiaoshenzhou Medical Techology Co., Ltd. is a leader in cell therapy within the oncology field, possessing core technologies that cover the entire process of gene and cell drug research, development, and production. The oncology field is one of Huadong Medicine's strategic focus areas, where we have achieved a leading 'multi-cancer type + multi-therapy' layout covering both solid tumors and hematological cancers. We have already established a strong market service team in the field of hematological tumor cell therapy. We are very pleased to collaborate with Beijing Yimiaoshenzhou Medical Techology Co., Ltd. to take charge of the commercialization of IM19 injection in mainland China. As a highly promising CAR-T product, IM19 injection will provide new treatment options for patients with diffuse large B-cell lymphoma, extending survival and improving quality of life. This will further enrich our company’s product portfolio in the field of blood disorders and create effective synergy with existing products."

According to the terms of the agreement, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. will receive an upfront payment of 125 million RMB and is eligible to receive registration and sales milestone payments of up to 950 million RMB. Beijing Yimiaoshenzhou Medical Technology Co., Ltd. will continue to be responsible for the development, registration, and production of IM19 Injection in mainland China.

About IM19 Injection

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, namely, relapsed/refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma, all of which have entered the registration clinical research phase. Among them, the study on end-line treatment for diffuse large B-cell lymphoma is about to complete Phase II clinical trials (confirmatory clinical trial), with positive clinical efficacy and safety data. The application for marketing authorization is expected to be submitted in the fourth quarter of 2024.

After the approval and market launch of IM19 Injection, it is expected to rank among the first tier of domestically produced CAR-T cell therapy drugs in China. It will effectively fill the market gap for domestically developed CAR-T products in the field of lymphoma indications, bringing new hope to hundreds of thousands of lymphoma patients in China.

Editor: Muyan

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