7 Million Psoriasis Patients See New Hope: China Launches Its First IL-23p19 Inhibitor Picankibart

By Dengyuemed International Business Department 

November 28 — The National Medical Products Administration (NMPA) has approved the marketing of picankibart injection, an innovative IL-23p19–targeting monoclonal antibody developed by Innovent Biologics. The drug is now indicated for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, making it the first domestically developed IL-23p19 inhibitor in China.

Picankibart (IBI112), marketed under the brand name Xinmeyue®, is a recombinant monoclonal antibody that specifically binds to the IL-23 p19 subunit, preventing its interaction with the IL-23 receptor and blocking downstream inflammatory signaling. Its approval represents a major scientific milestone in China’s autoimmune therapeutics field and provides a new treatment option for approximately 7 million patients living with psoriasis.

Phase III Trials Show Best-in-Class Efficacy: PASI 90 Response Exceeds 80%

In pivotal Phase III studies, picankibart achieved efficacy comparable to leading global IL-23p19 biologics:

• 80.3%of patients reached PASI 90 at Week 16
• 93.5%achieved an sPGA score of 0/1, significantly outperforming placebo

Notably, picankibart offers a 12-week maintenance dosing interval, one of the longest reported for IL-23p19 inhibitors, enhancing patient convenience without compromising efficacy.

In May 2024, Innovent Biologics announced that its Phase III CLEAR-1 trial met its primary and all key secondary endpoints. Picankibart also became the first IL-23p19 inhibitor globally to exceed an 80% PASI 90 rate at Week 16, underscoring its competitive advantage in the global biologics market.

Overview of the Global IL-23 Market

Prior to the launch of picankibart, five biologics targeting the IL-23 pathway (excluding biosimilars) had been approved worldwide:

• Ustekinumab(IL-12/23p40) — Johnson & Johnson
• Guselkumab(IL-23p19) — Johnson & Johnson
• Risankizumab(IL-23p19) — AbbVie
• Tildrakizumab(IL-23p19) — Sun Pharma
• Mirikizumab(IL-23p19) — Eli Lilly

These biologics dominate the global psoriasis market. In 2024 alone:

• Risankizumabglobal sales reached USD 11.7 billion
• Ustekinumabsales reached USD 10.36 billion
• Guselkumabachieved USD 3.67 billion

China has become an increasingly important market for these blockbuster drugs. In 2024, ustekinumab and guselkumab recorded more than RMB 1.2 billion and RMB 800 million in hospital-channel sales, respectively.

Landscape of Psoriasis Biologics Approved in China

Regulatory acceleration in China has fostered a diverse biologics ecosystem covering multiple therapeutic targets.

Below is a summary of new drugs approved by the NMPA for moderate-to-severe plaque psoriasis:

This makes China one of the most diverse biologics markets for psoriasis globally.

Over the past decade, multinational leaders such as Johnson & Johnson, Novartis, AbbVie, Amgen, and Bristol Myers Squibb—together with emerging domestic innovators like Innovent Biologics, Hengrui Pharma, and Leads Biolabs—have shaped a dynamic and highly competitive treatment landscape.

China’s Rising Global Influence in Psoriasis Innovation

China’s rapid approval of biologics for moderate-to-severe plaque psoriasis signals a major shift in the country’s role within the global immunology innovation ecosystem.

The IL-23 pathway has become one of the most active areas of global innovation. Prior to picankibart, established IL-23p19 inhibitors such as guselkumab and tildrakizumab were already available. Meanwhile, rapid advancements in IL-17 inhibitors (including secukinumab, ixekizumab, brodalumab, sonelokimab, bimekizumab) and TYK2 inhibitors (such as deucravacitinib) have broadened therapeutic options and aligned China with global treatment trends.

Within this rapidly evolving landscape, Hong Kong DengYueMed is playing an increasingly vital role as a pharmaceutical exporter, committed to excellence, innovation, sustainability, and social responsibility. By upholding quality, compliance, and integrity as core competitive strengths, the company is driving high-standard Chinese medicines to global markets—bringing safer, more advanced, and more affordable therapeutic solutions to patients worldwide, and contributing to global health through China’s growing innovation capacity.