China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing has been made in China for its drug candidate SHR0302, intended to treat active ankylosing spondylitis in patients who have responded poorly to non-steroidal anti-inflammatory drugs (NSAIDs).
Phase II/III Study Results Support Filing
The filing is supported by the SHR0302-302 study, a multi-center, randomized, double-blind, placebo-controlled Phase II/III study. The study assessed the efficacy and safety of SHR0302 in active ankylosing spondylitis and achieved the primary endpoint, meeting pre-set superiority standards. A total of 504 adult patients with active ankylosing spondylitis were enrolled, receiving either SHR0302 tablets or placebo treatment. The results demonstrated that SHR0302 showed statistically significant and clinically significant improvement in active ankylosing spondylitis at week 12 compared to placebo. Additionally, SHR0302 tablets exhibited good safety and tolerability in the treatment of patients with active ankylosing spondylitis.
SHR0302’s Potential and Global Reach
SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, is under multiple clinical studies for conditions including vitiligo, ulcerative colitis, Krohn’s disease, ankylosing spondylitis, psoriatic arthritis, and alopecia areata. Jiangsu Hengrui entered into a licensing deal with Arcutis (NASDAQ: ARQT) in 2018, granting the US firm exclusive rights to the drug in the US, European Union, and Japan.
Market Potential for Homegrown JAK1 Inhibitor in China
Currently, there is no homegrown JAK1 inhibitor on the market in China. Globally, JAK1 inhibitors such as Pfizer’s abrocitinib, Novartis’s Jakavi (ruxolitinib), Eli Lilly’s Olumiant (baricitinib), and AbbVie’s upadacitinib are commercially available. The potential approval of SHR0302 could fill a gap in the Chinese market for domestically developed JAK1 inhibitors.-Fineline Info & Tech
