Zelgen:Gecacitinib Hydrochloride received marketing approval

On June 15, the NMPA official website showed that Zelgen Pharmaceuticals’ Category 1 new drug Jicatinib has been approved for a new indication for the treatment of severe alopecia areata (Acceptance No.: CXHS2500046).
Alopecia areata is a common inflammatory non-scarring hair loss condition, ranking as the second most prevalent hair loss disorder worldwide. Approximately 147 million people globally are affected by alopecia areata, including about 4 million patients in China. Although the etiology of the disease is not fully understood, studies have identified that the JAK-STAT signaling pathway plays a critical role in the pathogenesis of alopecia areata.
Jicatinib is a novel JAK and ACVR1 dual inhibitor independently developed by Zelgen Pharmaceuticals. It effectively inhibits inflammation and suppresses excessive T-cell activation, while also significantly increasing dermal thickness, promoting hair follicle regeneration, and increasing hair follicle density.
In terms of safety, Jicatinib has demonstrated a favorable safety and tolerability profile in patients with severe alopecia areata. The most common adverse events (occurring in ≥10% of patients and at a higher rate than in the placebo group) included decreased neutrophil or white blood cell counts, elevated creatine kinase or lactate dehydrogenase levels, increased platelet count, upper respiratory tract infection, and hyperlipidemia. No deaths, malignancies, or thromboembolic events were reported.
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