AbbVie Submits New Drug Application in China for Risankizumab, an IL-23 Inhibitor, for Multiple Immune-Mediated Indications

On July 6, AbbVie's risankizumab (formerly known as risankizumab) injection and its subcutaneous injection form were accepted for marketing application in China by the Center for Drug Evaluation of the National Medical Products Administration.

Rrisankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to the IL-23 p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases.

Risankizumab was initially developed by Boehringer Ingelheim. In February 2016, AbbVie paid a $600 million upfront fee to acquire the global commercialization rights for risankizumab. Risankizumab was first launched in Japan in March 2019 for the treatment of adult patients with plaque psoriasis, pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis who have had an inadequate response to conventional therapies. It was subsequently approved in the United States and the European Union the following month.

According to the PharmaCube database, AbbVie has registered seven clinical studies in China for the treatment of adult active psoriatic arthritis, moderate to severe ulcerative colitis in adolescents aged 16 years and older and adults, and Crohn's disease. Among these, two Phase III studies and one Phase I study for the treatment of Crohn's disease have been completed.

In 2023, with the expiration of Humira's patent, Amgen's adalimumab biosimilar officially entered the U.S. market, marking the end of Humira's "reign." IL-23 antibody risankizumab and oral JAK1 inhibitor Rinvoq (upadacitinib) have strongly filled the gap, both delivering impressive results in 2022 with growth rates exceeding 50%, generating revenues of $5.165 billion and $2.522 billion, respectively. Based on the outstanding performance of these three products, there is no doubt that AbbVie's leadership position in the global autoimmune field remains unshakable.

Currently, three IL-23 targeted new drugs have been approved for marketing in China, namely Johnson & Johnson's Guselkumab (IL-23p19) and Ustekinumab (IL12/23p40), as well as Tiqrelizumab (IL23p19) introduced by PharmaKon.

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