Analysis of domestic and overseas marketing status, clinical progress and R&D dynamics of Guselkumab

In recent years, Guselkumab (Guselkumab), as the first humanized monoclonal antibody targeting the IL-23p19 subunit, has continued to attract attention in the global immune field. The drug was first approved in the United States in 2017 for the treatment of moderate to severe plaque psoriasis. It was subsequently launched in Europe, Japan, Canada and other markets, becoming one of the most widely used clinically available IL-23 inhibitors. In China, guselkumab has been officially approved for marketing in recent years. It is mainly used for the treatment of moderate to severe plaque psoriasis in adults. It can currently be prescribed in the dermatology and rheumatology departments of major hospitals. The domestic selling price is usually about four to five thousand yuan per box, which may fluctuate due to differences in specifications and hospital procurement. The drug has been included in the national medical insurance catalog, and the actual burden on patients has significantly decreased after reimbursement, but the specific reimbursement ratio will vary depending on provincial and municipal policies.

In terms of clinical efficacy, guselkumab has outstanding performance in the treatment of psoriasis. Major trials have shown that its achievement rate of PASI90 and PASI100 is significantly higher than that of traditional biological agents. VOYAGEThe research series has confirmed that the drug has a rapid onset, stable efficacy and long-lasting effect. In long-term follow-up, more than 80% of patients maintained a high level of skin lesion clearance. Its precise blocking mechanism for IL-23's key inflammatory pathways not only improves skin damage, but also reduces the risk of inflammation recurrence. In the field of psoriatic arthritis (PsA), the DISCOVER-1 and DISCOVER-2 studies have further confirmed that it can effectively improve joint pain, swelling and structural damage progression, and provide a more comprehensive control solution for joint patients. Currently, the drug is also undergoing multiple trials in immune-related diseases such as inflammatory bowel disease and hidradenitis suppurativa, and the development of potential indications has become a focus of future research and development.

From a safety perspective, guselkumab is considered to be better tolerant than many types of traditional immunosuppressants. The most common adverse reactions include nasopharyngitis, mild infection and injection site reactions. The overall incidence is low and mostly grade 1 to 2. Because its target is more precise and it does not broadly suppress the immune system, it has a lower risk of serious infections and tumors. It is currently one of the biological agents with better safety features. Long-term follow-up data shows that patients have maintained good safety after continuous use for many years, and no new major risk signals have been seen. However, clinical practice still recommends checking for potential infection risks before medication, and monitoring immune indicators and infection symptoms during treatment to ensure a balance between disease control and safe medication.

In terms of R&D trends, guselkumab has entered multiple markets around the worldIn phase III and long-term extension studies, pharmaceutical companies are promoting its application for indications in more immune diseases. For example, in the field of Crohn's disease, early studies have shown that it can reduce the inflammatory response of the intestinal mucosa and is expected to become an important complement to future IL-23 pathway treatments; in the field of hidradenitis suppurativa, it has also shown the potential to improve skin lesions and pain. In addition, as domestic biopharmaceutical research and development accelerates, many domestic companies are studying IL-23 target antibody drugs. However, guselkumab will still maintain its leading position in the market for a long time due to its early launch time, sufficient clinical evidence, and medical insurance access. Overall, this drug is still in the stage of clinical expansion and application deepening globally. Its excellent efficacy, safety and policy support make it one of the core options for the treatment of moderate to severe psoriasis.

Reference:https://en.wikipedia.org/wiki/Guselkumab