Clinical Success in Phase 3 Psoriasis Trial

InnoCare Pharma (09969.HK) announced that its internally developed, oral tyrosine kinase 2 (TYK2) allosteric inhibitor, fadeucravacitinib (ICP-488), has successfully met the primary and multiple secondary endpoints in a Phase 3 clinical trial conducted on patients with moderate-to-severe plaque psoriasis in China. This achievement builds upon the positive results from a Phase 2 clinical trial in October 2024, where 77.3% and 78.6% of patients in the fadeucravacitinib group achieved a 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 12, demonstrating superior efficacy compared to the placebo group (11.6%). While detailed data will be presented at a future conference, the successful Phase 3 trial is considered a critical milestone towards the final commercialization of the drug.

Innovative Mechanism of Action Through TYK2 Inhibition

fadeucravacitinib is a potent and selective oral allosteric inhibitor that binds to the JH2 (pseudokinase) domain of TYK2, a key enzyme in the immune system. The drug selectively blocks the signaling pathways of interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferon (IFN), which play a central role in autoimmune diseases and inflammation. This effectively regulates the main symptoms that cause suffering in psoriasis patients, such as skin inflammation and excessive proliferation of keratinocytes. By precisely targeting specific pathways, the drug is designed to minimize off-target toxicity, such as cardiovascular disease, compared to other JAK inhibitors.

Significant Market Advantage as an Oral Formulation

The global psoriasis treatment market is currently dominated by injectable biologics such as Humira and Cosentyx, requiring patients to undergo periodic injections, which poses physical and economic burdens. However, fadeucravacitinib, as an oral formulation that can be taken once daily, offers a significant improvement in patient convenience and adherence. It is expected to attract a broad range of potential patients who may have been reluctant to undergo injection therapy or discontinued treatment prematurely, resulting in high market penetration.

Increasingly Competitive TYK2 Inhibitor Landscape

The global TYK2 inhibitor market is currently led by Bristol Myers Squibb (BMS) with Sotyktu (deucravacitinib), which generated approximately $291 million in global sales in 2025. Takeda's zasocitinib (TAK-279) has recently emerged as a strong contender, demonstrating superior results compared to Sotyktu in a head-to-head Phase 3 trial, intensifying the competition for market leadership. InnoCare aims to leverage the success of its Phase 3 trial in China to capture the domestic market of 8.66 million psoriasis patients and accelerate global licensing agreements to compete with multinational pharmaceutical companies.

Regulatory Approval Timeline and Expansion of Global Pipeline

InnoCare plans to expedite the submission of a New Drug Application (NDA) based on the Phase 3 clinical data and in close consultation with regulatory authorities. Given that the Phase 3 trial was conducted on adult patients in China, the prospects for obtaining regulatory approval in the Chinese market are considered highly favorable. Furthermore, the company aims to maximize the platform value by diversifying the indications to include various autoimmune diseases such as cutaneous lupus erythematosus (CLE) and Sjögren's syndrome, presenting a long-term vision.