China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for HDM3001 (QX001S), a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab), for the treatment of moderate to severe plaque psoriasis.
Market Potential and Clinical Progress
The originator drug, Stelara, was approved to treat moderate to severe plaque psoriasis in China in September 2017. Currently, there is no biosimilar version of this drug available on the Chinese market, making HDM3001 a potentially significant entry. HDM3001 successfully concluded its Phase III clinical study in June 2023, marking a crucial step towards regulatory review and potential market approval.
Implications for Plaque Psoriasis Treatment
The acceptance of HDM3001 for review by the NMPA signifies a step forward in providing alternative treatment options for patients with moderate to severe plaque psoriasis in China. If approved, HDM3001 could offer a more accessible option, potentially increasing treatment options and improving patient outcomes.-Fineline Info & Tech
