Shanghai Pharmaceuticals Subsidiary Receives NMPA Approval for Ruxolitinib Phosphate Tablets

SHANGHAI — Changzhou Pharmaceutical Factory Co., Ltd., a subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. (SPH, 601607.SH), recently received approval from China's National Medical Products Administration (NMPA) to manufacture ruxolitinib phosphate tablets, the company announced. The regulatory green light, confirmed through three drug registration certificates numbered 2026S03098, 2026S03096, and 2026S03097, marks a significant expansion of treatment options for Chinese patients battling rare blood disorders.

The approval covers two major therapeutic areas: myelofibrosis and graft-versus-host disease (GVHD), both serious conditions with limited treatment alternatives.

For myelofibrosis patients, the drug is indicated for adults with intermediate or high-risk primary myelofibrosis (PMF), also known as chronic idiopathic myelofibrosis, as well as those with myelofibrosis secondary to polycythemia vera (PPV-MF) or essential thrombocythemia (PET-MF). The medication targets disease-related splenomegaly and associated symptoms.

The second indication addresses graft-versus-host disease, a potentially life-threatening complication following stem cell transplantation. Ruxolitinib tablets are approved for patients aged 12 and older with acute or chronic GVHD who have not responded adequately to glucocorticoids or other systemic therapies.

Ruxolitinib was originally co-developed by Incyte Corporation and Novartis AG. The drug first received U.S. Food and Drug Administration approval in November 2011, establishing itself as a cornerstone therapy for myeloproliferative neoplasms over the past decade.

The NMPA approval represents a milestone for SPH, one of China's largest pharmaceutical distributors and manufacturers, as it expands its portfolio of specialized therapies for rare diseases. With domestic production now authorized, Chinese patients may gain improved access to a treatment that has demonstrated efficacy in managing these complex hematologic conditions.

The arrival of a locally manufactured ruxolitinib option comes at a critical time, as China's regulatory authorities have been accelerating approvals for orphan drugs and rare disease treatments in recent years.