Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical study for the drug candidate SSGJ-608 has successfully met all primary endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all secondary efficacy endpoints in the treatment of moderate to severe plaque psoriasis. The company anticipates filing for market approval for SSGJ-608 in this indication in the near future.
The trial involved 458 patients with moderate to severe plaque psoriasis (PsO) who were randomly assigned in a 2:2:1 ratio to either study drug group A [160 mg at Week 0 (W0) + 80 mg every 2 weeks (Q2W) for the first 12 weeks + 80mg every 4 weeks (Q4W)], study drug group B [160 mg Q4W for the first 12 weeks + 160mg every 8 weeks (Q8W)], or a placebo group for the first 12 weeks, after which they were randomized to different study groups. The primary efficacy endpoint was the proportion of subjects achieving PASI 75 and sPGA 0/1 at week 12 of treatment. Key secondary efficacy endpoints included the proportion of subjects achieving PASI 90, PASI 100, and sPGA 0 at week 12, respectively. Secondary efficacy endpoints encompassed efficacy maintenance, recurrence, itch score, and quality of life assessment. The study demonstrated that all major, key, and secondary efficacy endpoints were successfully achieved, with the maintenance treatment regimen expected to offer the longest dosing interval for similar products. Efficacy indicators continued to increase and remain stable during the maintenance treatment period, showing strong competitive advantages compared to marketed products targeting the same pathway.
SSGJ-608 is designed to selectively bind to human IL-17A, neutralize its activity, effectively inhibit the release of inflammatory factors, and thereby inhibit the biological activity of IL-17A. There is currently no similar domestically produced product listed in China.- Flcube.com
