Johnson & Johnson (JNJ.US) falls heavily in the self-immunity field again.

Johnson & Johnson (JNJ.US) has made a major breakthrough in the field of medicine: its ustekinumab injection, under the name Gusigeyou, has successfully obtained approval from the NMPA for the diagnosis and treatment of moderate to severe active Crohn's disease in adult patients who have inadequate response to traditional treatment methods or biological agents, or who are intolerant to them. In recent years, with in-depth research on the pathogenesis of Crohn's disease, scientists have gradually realized the key role of the immune system in the occurrence and development of the disease. In particular, the abnormal activation of the IL-23 pathway in Crohn's disease is considered to be an important cause of continuous intestinal inflammation. Therefore, targeted therapy against the IL-23 pathway has become a new direction in the treatment of Crohn's disease. Ustekinumab is a specific anti-IL-23 monoclonal antibody, which is approved for the first time globally for the treatment of moderate to severe active adult Crohn's disease, and it provides a new treatment option for patients who have inadequate response to traditional or biological treatments, adding new power to the treatment field of Crohn's disease. As an IL-23 inhibitor, ustekinumab has a unique dual action mechanism. It can bind with high affinity to the p19 subunit of IL-23, precisely blocking the interaction between IL-23 and its receptor. It can also regulate the activity of immune cells in a specific way, inhibiting inflammatory responses from multiple dimensions, thereby showing significant advantages in the treatment of autoimmune diseases. In the field of Crohn's disease treatment, ustekinumab's advantages are fully demonstrated. According to the clinical data from two key phase III studies (GALAXI2 and GALAXI3) in the GALAXI research project, ustekinumab shows superior efficacy in multiple key indicators. In terms of clinical remission rate, patients receiving ustekinumab treatment have significantly higher remission rates than those in the traditional treatment group or the biological agents control group. After a certain course of treatment, many patients' symptoms such as abdominal pain and diarrhea significantly improve, leading to a noticeable improvement in quality of life. In terms of deep remission rate, ustekinumab also performs excellently, with more patients achieving deep remission of intestinal inflammation, as evidenced by endoscopic results showing significant repair of intestinal mucosal inflammation and damage. Ustekinumab is also the only interleukin-23 inhibitor that outperformed Ustekinumab in multiple endoscopic endpoints in a double-blind head-to-head trial (GALAXI). With the increasing emphasis on health and the in-depth research on the pathogenesis of autoimmune diseases, the global autoimmune drug market has shown a booming trend in recent years, becoming the next important market after oncology drugs. Predictive data shows that by 2030, the global market size of autoimmune disease drugs is expected to reach 176.7 billion US dollars, with the biologics market reaching 145 billion US dollars, accounting for 82.1%. Such a huge market cake has attracted fierce competition from many pharmaceutical companies. AbbVie occupies an important position in the autoimmune field with products such as adalimumab and ustekinumab. Sanofi's dupilumab, with its expanding indications, has become the "new king of autoimmune diseases" globally. Novartis, on the other hand, is focusing on the self-race track.The performance of S AG Sponsored ADR's Keytruda in the field of psoriasis treatment is remarkable, successfully defeating numerous competitors through a series of "head-to-head" clinical trials. In the sub-track of inflammatory bowel disease, Takeda's 47 antibody vedolizumab made an early bet and has now become the best-selling biologic in this field. Many pharmaceutical companies are increasing their research and development investments, continuously introducing new products and treatment plans through various methods such as independent research and development, mergers and acquisitions, and partnerships, all attempting to gain a foothold in this promising market.Johnson & Johnson, as a giant in the pharmaceutical industry, has made profound and comprehensive layouts in the field of immuno-oncology. Over the years, Johnson & Johnson has continuously invested a large amount of resources in research and development, constantly launching innovative drugs, leading the transformation of immuno-oncology treatment. Its drug Infliximab, as the first antibody drug discovered to have therapeutic effects in autoimmune diseases, was approved for market in 1998 for the induction treatment of active moderate to severe Crohn's disease and fistulizing Crohn's disease. Since then, it has successively achieved clinical success and approval in multiple indications such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, plaque psoriasis, etc. Over the 25 years since its launch, it has contributed over $90 billion in revenue to Johnson & Johnson. Ustekinumab, as a star product under Johnson & Johnson, is a promising immuno-oncology product. As an IL-12/IL-23 dual-target inhibitor, it has a pioneering mechanism of action and obvious uniqueness. Moreover, the dosing method of only needing a subcutaneous injection every 3 months greatly benefits patients. With these advantages, Ustekinumab has quickly risen in the field of immuno-oncology. In 2023, its sales achieved a major breakthrough, surpassing the $10 billion mark for the first time, reaching $10.858 billion. Even in 2024, despite a slight decrease due to market competition from biosimilars, its sales remained stable at a high level of $10.361 billion, demonstrating strong market competitiveness. Golimumab, administered through subcutaneous injection once a month, has become a blockbuster product with annual sales exceeding $2 billion. This time, Guselkumab was approved for the treatment of Crohn's disease, further enriching Johnson & Johnson's product line in the field of immuno-oncology. It not only provides a more powerful weapon for Johnson & Johnson in the treatment of inflammatory bowel disease, but also has the potential to quickly gain a certain market share with the help of Johnson & Johnson's strong marketing capabilities and sales network, further consolidating Johnson & Johnson's position in the field of immuno-oncology. In addition to the products already on the market, Johnson & Johnson is actively developing its pipeline in the field of immuno-oncology. Its orally administered White Blood Cell Interleukin-23 Receptor (IL-23R) antagonist Icotrokinra (JNJ-2113) has shown promising key results in the Phase III ICONIC-LEAD study for the treatment of moderate to severe plaque psoriasis patients aged 12 and above, demonstrating tremendous market potential. Conclusion Johnson & Johnson's approval of Guselkumab for the treatment of Crohn's disease is an important milestone in the field of autoimmune diseases, providing patients with new treatment opportunities and injecting momentum into the development of the field of autoimmune diseases. Source: WeChat public account "Pharma Intelligence", GMTEight editor: Chen Qiuda.