On November 27, Huadong Medicine announced that its Sometuximab Injection and Rilonacept for Injection were approved for marketing by NMPA. On the same day, the drug registration and marketing authorization application for CD19 CAR-T candidate IM19 chimeric antigen receptor T cell injection (hereinafter referred to as "IM19") was also accepted by NMPA.

Sometuximab Injection (ELAHERE®/ELAHERE®) is used for the indication of folate receptor α-positive platinum-resistant ovarian cancer (PROC) that has received 1-3 lines of systemic treatment in the past; Rilonacept for Injection (trade name: Yanduo®/ARCALYST®) is used to treat cold pyrine-associated periodic syndrome (CAPS) in adults and adolescents aged 12 years and above, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).

Suomitoximab is a drug targeting FRα targets and is the only platinum-resistant recurrent ovarian cancer treatment drug on the market in the world. According to public information, Suomitoximab can recognize target proteins on the surface of tumor cells, accurately attack tumor cells, and has efficient clinical treatment effects. At present, the drug has been recommended by the NCCN Guidelines (2024Version3) for monotherapy or combined treatment of FRα-positive PROC, becoming a new standard for the treatment of FRα-positive ovarian cancer.

In 2022, Suomitoximab injection was approved for marketing in the United States; in October 2023, Sino-US East China applied for marketing of the drug in China. Since its approval for marketing, Suomitoximab injection has maintained continuous growth. AbbVie's financial report shows that its sales in the third quarter of 2024 reached US$139 million, an increase of 32.23% over the same period last year, and sales in the first three quarters reached US$331 million, a year-on-year increase of 56.13%.

Suometuximab injection has been successfully approved for marketing in China. With Huadong Medicine's strong commercialization capabilities, this product is expected to quickly seize the blank market with its first-mover advantage.

At the same time, another product of Huadong Medicine in the field of oncology has also made significant progress: the listing application of IM19 has been accepted by CDE. According to public information, IM19 is a CD19 CAR-T candidate product. Huadong Medicine has its exclusive commercialization rights in mainland China. The application for this indication is relapsed or refractory CD19-positive non-Hodgkin's lymphoma, based on an open-label, single-arm, multicenter Phase I/II clinical trial conducted in China. The results of the study showed that IM19 has good efficacy and safety effects for relapsed or refractory CD19-positive non-Hodgkin's lymphoma (NHL).

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