On November 28, 2025, the official website of the National Medical Products Administration (NMPA) announced that the Class 1 new drug Picankibart Injection (brand name: Xinmeiyue^®, research and development code: IBI112) developed by Innovent Biologics (Hangzhou) Co., Ltd. (hereinafter referred to as “Innovent Biologics”) has been approved for marketing, intended for the treatment of moderate to severe plaque psoriasis (acceptance number: CXSS2400103, approval number: NMPA S20250066). The launch of this domestically produced innovative biologic not only breaks the long-term dependence on imported IL-23p19 target drugs in the field of psoriasis treatment, but its once-every-12-weeks maintenance dosing regimen also marks the official entry of China’s psoriasis treatment into a new phase of long-term management with “quarterly dosing”, providing a new treatment option for over 7 million psoriasis patients in China.

Picankibart is a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody independently developed by Innovent Biologics. It can specifically bind to the IL-23p19 subunit. This drug exerts anti-inflammatory effects by preventing IL-23 from binding to cell surface receptors and blocking the IL-23 receptor-mediated signaling pathway, thereby inhibiting the occurrence and development of inflammatory reactions at their source. This mechanism precisely targets the core pathological feature of psoriasis “immune-mediated chronic inflammation”, achieving the therapeutic goal of “precise anti-inflammation”. At the same time, Picankibart is also China’s first original IL-23p19 monoclonal antibody.

It is noteworthy that, in order to enhance the practicality of the drug, Picankibart has undergone innovative optimization in molecular design: by modifying the Fc fragment of the antibody, the half-life of the drug in the body has been significantly prolonged, laying a molecular foundation for subsequent “long-acting drug delivery”. This design not only distinguishes itself from traditional psoriasis treatment drugs but also endows it with unique pharmacokinetic advantages among similar biologics.

The approval for marketing is based on the positive results from a Phase III registered clinical study CLEAR-1 (NCT05645627), conducted in Chinese subjects with moderate to severe plaque psoriasis. This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aimed at evaluating the efficacy and safety of Picankibart in subjects with moderate to severe plaque psoriasis.

Before the approval of Picankibart, there were three IL-23p19 antibody drugs already available in the domestic market, namely, Johnson & Johnson’s Guselkumab, the Tildrakizumab introduced by China Medical System in cooperation with Sun Pharma, and Boehringer Ingelheim’s Rrisankizumab - all of which were imported or introduced through cooperation. As the first domestically produced original IL-23p19 monoclonal antibody, Picankibart not only fills the gap in independent research and development of this target drug in China, but also achieves a breakthrough in the convenience of drug administration.

Picankibart can be administered “once every 12 weeks” during the maintenance phase, which significantly significantly reduces the frequency of patients’ trips to the hospital, lowers the burden of medication, and is of great significance in improving long-term treatment adherence - and insufficient adherence was one of the main challenges previously faced by patients with moderate to severe psoriasis in their treatment. The long-term and repeated dosing process often leads to patients discontinuing treatment, affecting the effectiveness of disease control.

In terms of intellectual property, Picankibart injection currently holds one patent “201980042811.9” in China. The expiration date of this patent is November 27, 2039. Its current patent protection scope includes: 15 sequence structure claims for active ingredients of biological products (Claims 1-15); 17 claims for pharmaceutical uses of biological products (Claims 29-45). Its patent protection layout is relatively comprehensive, making it difficult for generic drug companies to challenge it.

References:

1. https://www.sohu.com/a/964315418_122279996

2. https://finance.sina.com.cn/roll/2025-12-01/doc-infzhiap2271639.shtml

3. https://mp.weixin.qq.com/s/Evn5llD0zYyfQyQXCuWZqw