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Rongchang Biotech: Approval granted for its marketing/launch application for an injectable Taltisep new indication to treat Sjögren’s syndrome

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Rongchang Biotech Announcement, recently, the company received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration. The application for the new indication of Taltisep (code: RC18, trade name: Tai Ai) for the treatment of Sjögren's syndrome (dryness disease) has been approved for market launch. This product is suitable for adult patients with Sjögren's syndrome (dryness disease) who have active disease (ESSDAI ≥ 5 points) on the basis of conventional treatment. The approval of this new indication for market launch is based on a nationwide multicenter, randomized, double-blind, placebo-controlled Phase III confirmatory clinical study. This study is currently the first successful completion of a Phase III clinical trial with highly positive results in the global autoimmune biologics field for Sjögren's syndrome, and it is a double-target innovative drug project.
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