CSPC Pharmaceutical Group Enters $10 Billion Daratumumab Market with Clinical Trial Approval in China

Recently, CSPC announced that the daratumumab injection developed by the group has been approved for clinical trials in China to treat adult patients with multiple myeloma. Data from Menet shows that global sales of daratumumab exceeded $10 billion in 2024, with sales in Chinese public medical institutions surpassing 1.2 billion yuan.

The daratumumab injection developed by the group is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38), and is a biosimilar of the original drug (brand name: DARZALEX). This product was registered as a new therapeutic biologic under category 3.3 and is indicated for the treatment of adult patients with multiple myeloma.

Daratumumab has experienced rapid growth in sales in recent years, with global sales exceeding $10 billion in 2024. In China, sales at public hospitals in cities, county-level public hospitals, urban community health centers, and township health clinics (referred to as Chinese public medical institutions) exceeded 1.2 billion yuan.

Data from MiNe Network shows that only Johnson & Johnson holds the production approval for Daratumumab Injection, with no domestic pharmaceutical companies currently under review for production. Three domestic pharmaceutical companies—Hangzhou Jiuyuan Gene, Zhengda Tianqing Nanjing Shunxin Pharmaceutical, and CSPC’s Jushi Biopharmaceutical—have been approved for clinical trials.

On December 19, CSPC announced that SYH2085, a Class 1 innovative chemical drug independently developed by the group, has been approved for clinical trials in China. This product is a novel oral small-molecule candidate drug that inhibits the RNA polymerase acidic protein (PA) endonuclease activity of influenza viruses. The approved clinical indication is for the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 years and above. On December 18, data from the topline analysis of a Phase III clinical trial assessing equivalence was obtained for Secukinumab Injection developed by CSPC’s subsidiary, CSPC Jushi Biopharmaceuticals. The product is a fully human IgG1 monoclonal antibody drug developed by the group as a biosimilar to Secukinumab Injection (trade name: Cosentyx).