Huadong Medicine Subsidiary Inks RMB 1.075 Billion Deal to Commercialize CD19-Targeted CAR-T Therapy IM19 in China

Pencil News, August 5: Huadong Medicine Co., Ltd. (referred to as Huadong Medicine) wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., has signed an exclusive commercialization cooperation agreement with Beijing Yimiao Shenzhou Medical Technology Co., Ltd. According to the agreement, Huadong Medicine (Hangzhou) will obtain the exclusive commercial rights in mainland China for Yimiao Shenzhou's IM19 Chimeric Antigen Receptor T-cell Injection (hereinafter referred to as "IM19"), a CD19-targeted autologous CAR-T candidate product.

Huadong Medicine (Hangzhou) will pay Beijing Yimiaoshenzhou Medical Technology Co., Ltd. 125 million RMB as an upfront payment, along with up to 950 million RMB based on registration and sales milestones. Huadong Medicine (Hangzhou) mainly engages in the wholesale and retail of pharmaceutical products and medical devices, with a registered capital of 50 million RMB.

Beijing Yimiao Shenzhou Medical Technology Co., Ltd. focuses on the development of innovative CAR-T cell therapies for the treatment of hematological malignancies and solid tumors. It possesses a one-stop gene and cell therapy R&D and industrialization platform, including core technologies such as plasmids, lentiviral vectors, and primary immune cell preparation systems, covering the entire process of gene and cell therapy research, development, and production.

IM19 CAR-T Cell Injection, a CAR-T cell therapy product independently developed by Beijing Yimiaoshenzhou Medical Technology Co., Ltd., has received clinical trial approvals from the National Medical Products Administration (NMPA) for three indications: relapsed/refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma. All have entered the registration clinical research phase. A drug marketing authorization application is expected to be submitted in the fourth quarter of 2024.

This collaboration will bring new growth points to Huadong Medicine in the field of oncology, particularly in hematological tumors. The company has established a rich product pipeline in the oncology sector, covering both solid tumors and hematological malignancies. This includes the commercially available small-molecule immunomodulatory National Class 1 innovative drug Epimedium-derived soft capsule, as well as several products currently under research and development.

Huadong Medicine will continue to focus on clinical needs and patient health, deepen its core strategic areas, adhere to the "self-research + introduction" dual-driven approach, accelerate the establishment of innovative projects and the introduction of external innovative businesses, continuously enrich its product pipeline, and consolidate the company's international layout and market-leading position in the three major fields of oncology, endocrinology, and autoimmune diseases.