Haisco’s class 1 small-molecule PNH drug has been approved for marketing in China

Today (July 23), the National Medical Products Administration (NMPA) of China announced that it has approved the marketing of Haisco Pharmaceutical‘s Class 1 innovative drug, Succinate Spocoman tablets (HSK39297), through the priority review and approval procedure. It is indicated for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

Publicly available information shows HSK39297 is a highly effective selective small molecule inhibitor of complement factor B (FB). This product inhibits FB activity, thereby blocking the activation of the alternative pathway (AP) and complement amplification cycle, thus inhibiting the activity of the entire complement pathway. It aims to treat various diseases mediated by abnormal complement activation. In addition to the approved indication, this product is also under development for the treatment of lupus nephritis, primary IgA nephropathy, and other conditions.

Clinical studies have shown that HSK39297 is well-tolerated and safe. High levels of efficacy were observed in subgroups of patients with different ages, sexes, duration of PNH, and pre-treatment Hb levels, indicating that patients in different subgroups can significantly benefit. HSK39297 has significant therapeutic advantages over eculizumab in improving anemia, reducing transfusion requirements, and alleviating fatigue symptoms, and its efficacy can be maintained long-term.

In June, Haisco announced an exclusive licensing agreement with Nuvectis Pharma, granting Nuvectis exclusive rights to develop, manufacture, and commercialize HSK39297 globally, excluding Greater China, Southeast Asia, and India.

Source: Haisco Pharma | Top Image: Pixabay