Huadong Medicine Inks $125M Deal for Exclusive Commercialization of YiSiao's CD19-Targeted CAR-T Therapy IM19 in China

China Finance and Economics Network, August 4th: Huadong Medicine (000963.SZ) announced today that its wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd. ("Huadong Medicine (Hangzhou)"), has signed an exclusive commercialization cooperation agreement with Beijing Yimiaoshenzhou Medical Technology Co., Ltd. ("Yimiao Shenzhou").

Huadong Medicine (Hangzhou) has obtained the exclusive commercial rights in China for Beijing Yimiaoshenzhou Medical Technology Co., Ltd.'s IM19 Chimeric Antigen Receptor T-Cell Injection (“IM19 CAR-T Cell Injection”), a CD19-targeted autologous CAR-T candidate product. Huadong Medicine (Hangzhou) will pay Beijing Yimiaoshenzhou an upfront payment of 125 million RMB, along with registration and sales milestone payments of up to 950 million RMB.

The announcement shows that IM19 CAR-T cell injection has successively obtained drug clinical trial approval notices for three indications: relapsed/refractory diffuse large B-cell lymphoma (r/r-DLBCL), acute B lymphoblastic leukemia (B-ALL), and mantle cell lymphoma (MCL), and all have entered the registration clinical research stage. 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 good clinical efficacy and safety data. It is expected to submit a drug marketing authorization application in the fourth quarter of 2024.

It is reported that CAR-T cell therapy, also known as "Chimeric Antigen Receptor T-Cell Immunotherapy," involves researchers extracting T cells that perform immune functions from patients and editing them in the lab to produce proteins called Chimeric Antigen Receptors (CAR). When the CAR-T cells are reinfused into the patient, they seek out and destroy specific targets.

Huadong Medicine Acquires IM19 CAR-T Cell Injection for Hematologic TumorsThe acquired IM19 CAR-T Cell Injection by Huadong Medicine is indicated for hematologic tumors. Among these, diffuse large B-cell lymphoma, mantle cell lymphoma, and acute lymphoblastic leukemia, as representative subtypes of hematologic tumors, are currently incurable with high risks of relapse/refractory cases, poor prognosis, and low rates of remission, duration of remission, and survival time, indicating significant unmet clinical needs.

According to WHO data, there were approximately 1.305 million new cases of hematological malignancies globally in 2021. According to GLOBOCAN 2022 data, non-Hodgkin lymphoma (NHL) ranks as the 10th most common malignant tumor globally and is the most prevalent hematological malignancy. Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL. In 2022, there were 553,000 new cases of NHL globally, with 250,000 deaths, accounting for 2.8% and 2.6% of all malignant tumor incidence and mortality, respectively.

The announcement shows that the IM19 CAR-T Cell Injection is expected to submit its market application in the fourth quarter of 2024. Once on the market, it is likely to rank among the first group of domestically produced CAR-T cell therapy drugs in China, effectively filling the market gap for domestically produced autonomous CAR-T products in lymphoma indications.

In terms of clinical layout, the IM19 CAR-T cell injection has promising prospects. The research targeting end-stage treatment for diffuse large B-cell lymphoma is about to complete Phase II clinical trials (confirmatory clinical trial), with favorable clinical efficacy and safety data. Studies focusing on acute B lymphoblastic leukemia and mantle cell lymphoma have completed the infusion for all subjects in Phase I and are about to enter Phase II clinical trials. In the future, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. also plans to initiate clinical trials for second-line treatment of diffuse large B-cell lymphoma.

Huadong Medicine stated that this acquisition will further strengthen its layout advantages in the oncology sector, particularly in the field of hematological tumors. "In the field of oncology, the company focuses on innovative therapies, with a key emphasis on ADC new drugs and CAR-T products. By differentiating its product pipeline, it is committed to breaking through and enhancing existing treatment methods, offering patients new therapeutic options. Currently, driven by a model of independent research and external collaboration, the company has established a rich product pipeline in the oncology field, with more than ten globally innovative drugs covering both solid tumors and hematological malignancies."