China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-5965. The study will focus on complement-mediated hemolytic anemia, including conditions such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and cold agglutinin disease.
Mechanism of Action and Preclinical Results
HRS-5965 works by inhibiting excessive activation of the complement system, thereby reducing complement system-mediated hemolysis. Preclinical studies have demonstrated significant inhibitory effects on complement-mediated hemolysis models, while also indicating a good safety profile. Currently, there is no similar product approved for marketing in China.
Investment and Development
To date, Hengrui Pharmaceuticals has invested RMB 40.16 million (USD 5.86 million) in the development of HRS-5965. This approval marks a significant milestone in the company’s efforts to bring innovative treatments to patients with hemolytic anemia, addressing a significant unmet medical need.-Fineline Info & Tech
