AbbVie’s IL-23 Inhibitor Risankizumab Receives NMPA Approval in China for Moderately to Severely Active Crohn’s Disease

Mar 10, 2025 12:26 CST Updated 12:26

AbbVie

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Today (March 10),AbbVie Inc. announced itsRisankizumab InjectionAndRisankizumab Injection (Subcutaneous Injection)The listing application has been approved.National Medical Products Administration (NMPA)Approved for the treatment ofAdult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologics。Risankizumab is a key product of AbbVie in the field of autoimmune diseases.This approval includes two formulations of Risankizumab Injection and Risankizumab Injection (Subcutaneous), featuring a portable drug delivery device.

RisankizumabIt is a humanized, IgG1 subtype monoclonal antibody that can selectively antagonize IL-23 by binding to the p19 subunit of IL-23. IL-23 is a cytokine associated with inflammation and is considered to be related to many chronic immune diseases.

BenefitShengqi Zhu Monoclonal AntibodyIt was first approved for marketing in Japan in March 2019, globally, for the treatment ofPsoriasis and Psoriatic ArthritisPatient. Subsequently, in April 2019, it was approved by the U.S. FDA.ApprovalLaunched for the treatment ofModerate to Severe PsoriasisPatients. The product was also listed by Clarivate as one of the most anticipated new drug launches in 2019. As of June 2024, the FDA has approved the product for treating four immune-mediated inflammatory diseases, includingPsoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Publicly available information shows that the dosing regimen for Risankizumab includes administration via intravenous (IV) infusion during the induction treatment phase.A dose of 1200mg was administered 3 times every 4 weeks for a total of 12 weeks.. Subsequently, enter the maintenance treatment phase,Starting from Week 12, the recommended maintenance dose of 180mg or 360mg is administered subcutaneously (SC) every 8 weeks thereafter., depending on the individual patient's response. Additionally, after the completion of induction therapy, patients stillCan be treated at home using an on-body injector (OBI).OBI is a hands-free device designed for patients that can be adhered to the body and prepared according to instructions.It takes approximately 5 minutes to complete the administration.。

According to the press release from AbbVie, in two induction clinical studies and one maintenance treatment clinical study, risankizumab showed significant results compared to placebo.Induction Therapy and Maintenance Therapy in Endoscopic Response(Defined as a reduction of >50% in the Simple Endoscopic Score for Crohn’s Disease [SES-CD] from baseline or, for patients with isolated ileal disease and a baseline SES-CD of 4, a decrease of at least 2 points from baseline) andClinical Remission(Defined as Crohn's Disease Activity Index [CDAI] <150) showed significant improvement.

In the ADVANCE and MOTIVATE induction studies, a significantly higher proportion of patients receiving risankizumab 600mg IV achieved the co-primary endpoints of endoscopic response and clinical remission (per SF/AP).
In the FORTIFY maintenance study, a significantly higher proportion of patients receiving risankizumab 360mg SC achieved the co-primary endpoints, which were endoscopic response and clinical remission (according to SF/AP).
In the ADVANCE and MOTIVATE induction studies, receivingRisankizumabA significantly higher proportion of patients treated with 600mg IV achieved endoscopic remission and mucosal healing.

This TimeRisankizumab Approved for Marketing in China, Poised to Benefit Chinese Patients Soon

References:

[1] Specific Interleukin-23 Inhibitor Skyrizi® Approved in China for the Treatment of Adult Active Crohn's Disease. Retrieved Mar 10，2025, from https://mp.weixin.qq.com/s/szgHy7vptobPj_N9AhXBIg

[2] FDA Approves SKYRIZI® for the Treatment of Ulcerative Colitis, AbbVie Expands Its Product Portfolio in the Inflammatory Bowel Disease Field.Retrieved Jul 26，2024, from https://mp.weixin.qq.com/s/WnNJWFBryakfoiJKlo_Eag

[3] China Drug Clinical Trial Registration and Information Disclosure Platform Official Website. From http://www.chinadrugtrials.org.cn/index.html

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