Shanghai Pharmaceuticals Receives Production Approval for Ruxolitinib Phosphate Tablets

Stock News08-31

Shanghai Pharmaceuticals Holding Co.,Ltd. (601607.SH) has announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., has obtained the Drug Registration Certificates (Certificate Nos. 2026S03098, 2026S03096, and 2026S03097) from China's National Medical Products Administration for Ruxolitinib Phosphate Tablets, officially authorizing production of the drug.

The approval covers specific therapeutic indications. Firstly, it treats myelofibrosis in adult patients with intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), addressing disease-related splenomegaly or associated symptoms.

Secondly, the drug is indicated for graft-versus-host disease (GVHD) in patients aged 12 and above who have inadequate response to glucocorticoids or other systemic therapies, covering both acute GVHD and chronic GVHD. The drug was jointly developed by Incyte and Novartis, and was first launched in the United States in November 2011.

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