Jiangsu Hengrui Pharmaceuticals (600276.SH): A new fifth indication for Alectinib sulfate tablets has been approved.
Hengrui Medicine (600276.SH) announced that it has recently received notification from the National Medical Products Administration, approving the addition of a fifth indication for its independently developed Class 1 innovative drug, Sulfate of Amivantamab Tablets (SHR0302). The approved indication: This product is indicated for adult patients with active radiographic-negative axial spondylarthritis who have inadequate response to or intolerance of non-steroidal anti-inflammatory drugs (NSAIDs) and show objective signs of inflammation (manifested as elevated C-reactive protein [CRP] and/or abnormal magnetic resonance imaging [MRI]).
Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that it has recently received notification from the National Medical Products Administration approving the addition of a fifth indication for its independently developed Class 1 innovative drug, Sulfate Emapalumab Tablets (SHR0302). The approved indication is as follows: this product is indicated for adult patients with active radiographic axial spondyloarthritis who have inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) and present with objective inflammatory signs (indicated by elevated C-reactive protein [CRP] and/or abnormal magnetic resonance imaging [MRI]).
Sulfate Emapalumab Tablets have previously been approved for four indications in China: 1. For adult patients with active ankylosing spondylitis who have inadequate response or intolerance to one or more TNF inhibitors. 2. For adult patients with moderate to severe active rheumatoid arthritis who have inadequate response or intolerance to one or more TNF inhibitors. 3. For adult patients with moderate to severe atopic dermatitis who have inadequate response or intolerance to topical therapies or other systemic treatments. 4. For adult patients with severe alopecia areata. With the approval of this new indication, the product now achieves oral targeted management coverage for the entire disease spectrum of axial spondyloarthritis.
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