Zelgen Pharma's gecaxitinib approved for myelofibrosis in China
Suzhou Zelgen Biopharmaceuticals (SSE:688266) announced that its independently developed Gecaxitinib Hydrochloride Tablets (brand name: Ze Pu Ping) have been approved by the National Medical Products Administration for treating adults with intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF), specifically targeting spleen enlargement or related symptoms. This marks the first approved indication for Gecaxitinib and the first domestic JAK inhibitor approved for myelofibrosis in China. The approval was based on positive results from a Phase III clinical trial, demonstrating a spleen volume reduction rate (SVR35) of 72.3% at 24 weeks. The drug has also been included in the CSCO guidelines for malignant hematological diseases and is projected to positively impact the company's future financial performance. According to industry estimates, the Chinese market for myelofibrosis drugs is anticipated to reach CNY 29.3 billion by 2025 and CNY 33.0 billion by 2030. Zelgen also has an NDA for the drug for severe alopecia areata accepted by the NMPA.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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