Recently, Zaijing Pharmaceuticals announced that its independently developed Class 1 new drug, gecacitinib hydrochloride tablets (formerly known as jactinib hydrochloride tablets), has met its primary efficacy endpoint in a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial for the treatment of moderate to severe atopic dermatitis in adult patients , demonstrating statistical significance (p<0.0001). This signifies another major breakthrough for Zaijing Pharmaceuticals in the field of autoimmune diseases.

Gecacitinib is a novel dual inhibitor of JAK and ACVR1 independently developed by Zaijing Pharmaceuticals , and is classified as a Class 1 new drug.

This drug received NMPA approval in May 2025 for the treatment of intermediate- and high-risk myelofibrosis, making it the first domestically produced innovative JAK inhibitor approved for the treatment of myelofibrosis. In addition, the NMPA has accepted the NMPA application for the indication of severe alopecia areata and is currently under review and approval; the three clinical trials for the treatment of active ankylosing spondylitis have met their primary efficacy endpoints.

This phase 3 clinical trial, targeting patients with moderate to severe atopic dermatitis, was conducted in 57 hospitals and enrolled 443 patients. The primary efficacy endpoint was the percentage of participants who achieved a ≥75% reduction in eczema severity and area index from baseline (EASI-75) at 16 weeks and a ≥2-point reduction in their overall investigator's assessment score from baseline (IGA 0/1) of 0 or 1.

The results showed that both doses of gecacitinib hydrochloride tablets were significantly higher than those of the placebo control group, reaching statistical significance (p<0.0001).

showed good safety and tolerability in treating patients with moderate to severe atopic dermatitis .

In addition, the extended trial of gecacitinib for the treatment of atopic dermatitis (AD) (ZGJAK026) has completed database locking. Zaijing Pharmaceuticals stated that it will accelerate the market launch process for gecacitinib hydrochloride tablets for the treatment of moderate to severe atopic dermatitis.

Atopic dermatitis (AD) is one of the most common chronic inflammatory skin diseases. Its course is prolonged, and the itching is intense, which seriously affects the quality of life of patients throughout their entire lifespan.

According to Frost & Sullivan, the number of AD patients in China was 72.9 million in 2024, and is projected to reach 79.2 million and 81.6 million in 2030 and 2035 respectively, showing an upward trend.

As the limitations of traditional treatments in terms of long-term efficacy and safety become increasingly apparent, oral small molecule JAK inhibitors, with their unique advantages of precise targeting and rapid onset of action, are reshaping the treatment pathway for moderate to severe atopic dermatitis, providing a powerful tool for achieving "zero itching" and "complete clearance of skin lesions".

Currently, several imported JAK inhibitors have been approved for targeted therapy in Alzheimer's disease (AD) in China. In 2025, Hengrui Medicine's imaxitinib was successfully approved for marketing, marking a breakthrough for domestically produced JAK inhibitors. Furthermore, the successful clinical trials of gecacitinib in AD further strengthened the competitiveness of domestically produced drugs.

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