Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, the company received a notice from the State Drug Administration to approve the addition of a fifth indication to the Class 1 innovative drug emaxitinib sulfate tablets (SHR0302 tablets) independently developed by the company. Approved indications: This product is intended for adult patients with active radiologic negative axial spondyloarthritis who respond poorly or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs) and have objective signs of inflammation (expressed as elevated C-reactive protein [CRP] and/or abnormal magnetic resonance imaging (MRI)).

Emaxitinib sulfate tablets have previously been approved for marketing in China for four indications, namely: 1. They are used in adult patients with active ankylosing spondylitis who have poor efficacy or intolerance to one or more TNF inhibitors. 2. Used for adult patients with moderate to severe active rheumatoid arthritis with poor efficacy or intolerance to one or more TNF inhibitors. 3. For adult patients with moderate to severe atopic dermatitis who do not respond adequately or are intolerant to topical topical treatment or other systemic treatments. 4. For adult patients with severe alopecia areata. After approval of this new indication, the product has achieved oral targeted management coverage of the entire disease spectrum of axial spondyloarthritis.

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