Janssen China's STELARA® (Ustekinumab) Granted New Indication for Adults with Crohn's Disease in China

From Jike Pharma News

On the 12th, Xian Janssen announced its Stelara^®（STELARA^®two formulations, subcutaneous ustekinumab injection and intravenous ustekinumab infusion (intravenous infusion), have been approved by the National Medical Products Administration of China for adult patients with moderate to severe active Crohn's disease (CD) who have had an inadequate response, lost response, or intolerance to conventional therapy or tumor necrosis factor-alpha (TNFα) antagonists. This accelerated approval was facilitated by the inclusion of Stelara on May 29, 2019, by the National Medical Products Administration and the National Health Commission.^®Included in the Second Batch of the List of Overseas New Drugs Urgently Needed for Clinical Use. Stelara^®It was first approved in China in November 2017 for the treatment of moderate-to-severe plaque psoriasis. The indication for adult Crohn’s disease is the second indication approved for it in China.

Stelara^®(Ustekinumab) is the first fully human "dual-target" interleukin-12 (IL-12) and interleukin-23 (IL-23) inhibitor approved in China. It works by inhibiting the shared p40 subunit of IL-12/IL-23, blocking pro-inflammatory factors such as IL-17 produced by Th17 cells, thereby suppressing inflammation and alleviating skin lesions. Notably, this product features an innovative dosing regimen—subcutaneous injection once every three months during the maintenance phase. Stelara^®The dosing regimen involves an initial single intravenous (IV) infusion based on body weight to rapidly help improve the condition; after 8 weeks, initiate 90 mg subcutaneous injections, followed by recommended 90 mg subcutaneous injections every 12 weeks thereafter to help maintain sustained disease control.

Crohn’s disease is a type of inflammatory bowel disease (IBD), a chronic condition characterized by inflammation or ulceration of the intestinal tract. It manifests as focal, asymmetric, transmural inflammation that can affect any part of the gastrointestinal tract, sometimes accompanied by granuloma formation, and primarily involves the ileum and colon. Clinical features of moderate-to-severe disease include strictures that may obstruct the intestine, as well as abscesses and fistulas. Typical symptoms of Crohn’s disease include chronic diarrhea, abdominal pain, weight loss, decreased appetite, fever, and rectal bleeding, all of which significantly impact patients’ quality of life. Crohn’s disease can affect individuals of any age but is most common in those aged 20–30 years. In China, there are slightly more male patients than female patients. Over the past 20 years, the incidence of IBD in China has shown a year-on-year increase, with the estimated incidence of Crohn’s disease at 0.4 per 100,000 population. Crohn’s disease typically onset during young adulthood, a critical period for personal development, thereby seriously affecting patients’ academic and career pursuits. The 2019 guidelines from the European Crohn’s and Colitis Organisation (ECCO) recommend Stelara^®Can be used as a first-line biologic agent for the treatment of moderate-to-severe Crohn's disease. Leveraging a novel interleukin mechanism of action, Stelara^®Characterized by rapid onset and sustained maintenance of remission. Stelara^®The approval of the new indication marks a significant advancement in the treatment of Crohn’s disease in China, providing a novel therapeutic option for Chinese patients with Crohn’s disease, particularly those with moderate-to-severe disease.

References:

[1] Stelara, under Xian Janssen^®(Ustekinumab) Gains New Indication for Adult Crohn’s Disease. Retrieved 2020-03-12, from https://mp.weixin.qq.com/s?__biz=MzAwNzI1MjYwNQ==&mid=2653233478&idx=1&sn=209741f344c0c7a6ae3c58d928d4e3f1&chksm=80d17e54b7a6f742d19af8c07dcc5c2135189880be535e15fa44f80044374ae4bd0590a0b28a&mpshare=1&scene=1&srcid=&sharer_sharetime=1583982585117&sharer_shareid=6112cda55a00a4e4fb13431ff0806410#rd

Original Title:Breaking News! Stelara, under Xian Janssen^®(Ustekinumab) Approved in China for New Indication in Adult Crohn’s Disease

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