Fosun Pharma's Oral TYK2/JAK1 Inhibitor, FXS5626, Enters Phase 2 Clinical Trial for Non-Infectious Uveitis
Clinical Trial Commences for Oral Uveitis Treatment
Fosun Pharma has initiated a Phase 2 clinical trial (NCT07552012) in China for 'FXS5626 (development code AC-201),' an oral selective tyrosine kinase 2 and Janus kinase 1 (TYK2/JAK1) inhibitor, which it acquired from Accro Bioscience. The trial will evaluate the efficacy and safety of FXS5626 in patients with non-infectious uveitis. The study will enroll 40 patients with non-infectious uveitis (anterior, intermediate, posterior, or panuveitis) and administer the drug twice daily for 24 weeks. This marks the first step in exploring the potential of FXS5626 as an oral medication to overcome the limitations of existing treatments.
Aiming to Overcome Existing Steroid and Injectable Treatments
Non-infectious uveitis is a serious ophthalmic disease that can lead to blindness. For a long time, steroid eye drops or systemic steroids have been used as the standard of care. However, steroids have significant side effects, such as cataracts and increased intraocular pressure, which severely limit their long-term use. Biologic agents, such as AbbVie's 'Humira (adalimumab),' are used as alternatives, but their injectable form presents challenges in terms of patient convenience and compliance. Therefore, the introduction of an oral option like FXS5626 could provide significant convenience to patients and potentially reduce healthcare costs.
Precise Inhibition of Autoimmune Targets
FXS5626 is a next-generation immunomodulatory agent that selectively blocks the JH2 pseudokinase domain of TYK2 and JAK1, which are key signaling pathways in autoimmune and inflammatory diseases. Unlike first-generation JAK inhibitors, which have broad target inhibition and potential risks of adverse effects such as shingles and cardiovascular events, FXS5626 is designed to maximize binding selectivity and minimize side effects. It has already demonstrated excellent safety and anti-inflammatory efficacy in a Phase 2 clinical trial for psoriasis, raising expectations that it will show positive therapeutic responses in the uveitis clinical trial by controlling the inflammatory microenvironment in the eye. Priovant Therapeutics' 'brepocitinib,' a leading drug in the same class, has shown positive results in a Phase 2 clinical trial, further increasing the prospects for FXS5626.
Deal Structure and Commercial Value in the Asian Market
In August 2025, Fosun Pharma entered into an exclusive licensing agreement with Accro Bioscience for the Greater China region, with a total value of 156 million yuan (approximately $21.6 million), to strengthen its ophthalmic pipeline. The agreement includes an upfront payment of 60 million yuan (approximately $8.3 million) and a milestone payment of 20 million yuan (approximately $2.8 million) for technology transfer. Additional milestone payments of 76 million yuan (approximately $10.5 million) will be made based on clinical progress, as well as commercial milestone payments and royalties. The global market for non-infectious uveitis treatment is expected to grow rapidly from $2.15 billion in 2024 to $4.6 billion in 2032, with an annual growth rate of over 8%. If Fosun Pharma can secure the Greater China market and expand into global partnerships, it is expected to generate significant commercial profits.
With the global non-infectious uveitis market rapidly growing from $2.15 billion in 2024 to $4.6 billion in 2032, the initiation of the Phase 2 clinical trial for FXS5626, the first oral TYK2/JAK1 selective inhibitor, represents a critical turning point that could potentially replace the existing standard of care, which relies on injectable treatments like Humira. From an investor's perspective, this trial will provide key clinical data to assess the value and commercial success of Fosun Pharma's $21.6 million licensing agreement, which includes an $8.3 million upfront payment. For researchers and industry professionals, the safety profile and minimization of side effects of FXS5626 compared to the efficacy demonstrated by Priovant's brepocitinib in Phase 2 trials will be a key factor in shaping the development of next-generation oral treatments for autoimmune ophthalmic diseases. In the long term, the success of this oral treatment could significantly enhance the pipeline value of Asian autoimmune disease pharmaceutical companies and expand opportunities for licensing agreements.
Source: ClinicalTrials.gov (api_ct)