Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate to severe plaque psoriasis.
Phase III Study Results and Efficacy
The final results from the pivotal regulatory Phase III study for SSGJ-608 in treating moderate to severe plaque psoriasis were revealed in August this year. The study demonstrated that all primary efficacy endpoints, including PASI 75 and sPGA 0/1, were met, along with key secondary efficacy endpoints such as PASI 90, PASI 100, and sPGA 0, and all other secondary efficacy endpoints. SSGJ-608’s maintenance treatment regimen is anticipated to have the longest dosing interval among similar products, with various efficacy indicators showing continued increase and stability during the maintenance treatment period.
Competitive Advantage of SSGJ-608
Compared to marketed products targeting the same IL-17A pathway, SSGJ-608’s induction therapy (12 weeks) and maintenance therapy (52 weeks) efficacy data present strong competitive advantages. This positions SSGJ-608 as a potentially leading therapy in the treatment of plaque psoriasis, offering patients a more effective and longer-lasting treatment option.-Fineline Info & Tech
Leave a Reply