On January 22, AbbVie announced that risankizumab (trade name: Xikaiyue) has been approved in China for its second indication: the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate, unresponsive, or intolerant attitude to conventional or biologic therapies. Risenzilumab is an IL-23 inhibitor that selectively blocks IL-23 by binding to the IL-23p19 subunit. IL-23 is a cytokine involved in the inflammatory process and is believed to be associated with many chronic immune-mediated diseases. On March 10, 2025, Risenzilumab was first approved for marketing in China for the treatment of adult patients with moderate to severe active Crohn's disease who have an inadequate response, loss of response, or intolerance to conventional or biologic therapies.This approval for the new indication is based on the positive results of the INSPIRE and COMMAND Phase III clinical trials.The results showed that in the INSPIRE induction therapy trial, levosizumab treatment for 12 weeks significantly improved the clinical response rate compared with placebo (20.3% vs 6.2%; adjusted intergroup difference 14.0% [95% CI: 10.0%–18.0%]; P < 0.001); in the COMMAND maintenance therapy trial, the clinical response rates of both 180 mg and 360 mg maintenance doses for 52 weeks were significantly better than those of placebo (40.2% vs 37.6% vs 25.1%).Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease that causes inflammation of the digestive tract mucosa and damage to the intestines. In recent years, the incidence of UC in my country has been rising continuously, commonly occurring in young adults aged 20-49. Patients often experience symptoms such as diarrhea, rectal bleeding, urgency, abdominal pain, nocturnal defecation, tenesmus, fecal incontinence, sleep disruption, and fatigue. In severe cases, patients may have more than 10 bowel movements a day, accompanied by severe colic and persistent bleeding, significantly impacting their daily life and work. Studies show that approximately one-fifth of patients are unable to work or study normally due to the disease. Long-term illness and recurrent flare-ups can also lead to psychological problems such as sleep disorders, fatigue, anxiety, and depression. More challenging is the risk of colorectal cancer for patients with long-term disease (e.g., over 10 years). In short, UC has become a systemic disease that poses a long-term threat to patients' health and quality of life.
In China, in March 2025, the NMPA (National Medical Products Administration) first approved lecithinumab for the treatment of adult patients with moderate to severe active Crohn's disease who have an inadequate response, loss of response, or intolerance to conventional or biologic therapies . The approved dosage forms include lecithinumab injection and lecithinumab injection (subcutaneous injection). This is the second indication approved in China.
To date, the drug has been approved for multiple indications worldwide, including Crohn's disease, plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis. In the field of plaque psoriasis , levosiniculumab has outperformed four commonly used drugs: ustekinumab, adalimumab, secukinumab, and apromis.
After its listing, sales of Risenkirumab surged, with global sales of US$2.939 billion, US$5.165 billion, and US$7.763 billion in 2021, 2022, and 2023, respectively . In 2024, global sales reached US$11.718 billion , joining the US$10 billion club.
Other IL-23-targeted drugs already approved for the treatment of Crohn's disease include Eli Lilly's mijizumab and Johnson & Johnson's ustekinumab (the original drug). Among them, mijizumab was approved by the U.S. FDA on January 15, 2025, for the treatment of adult patients with moderate to severe active Crohn's disease.
Johnson & Johnson announced that its guselkumab injection has been approved in China , becoming the first interleukin-23 inhibitor in China for the treatment of active Crohn's disease. It is indicated for adult patients with moderate to severe active Crohn's disease who have an inadequate, non-responsive, or intolerant attitude to conventional therapies or biologics. This approval marks the first global approval of guselkumab for the Crohn's disease indication.

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