Accro Bioscience Announces First Patient Enrolled in Phase II/III Clinical Trial of Highly Selective TYK2/JAK1 Inhibitor AC-201 for Non-Segmental Vitiligo
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NEW YORK and SUZHOU, China, Nov. 11, 2026 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited ("Accro Bioscience" or "Accro") today announced that its partner's subsidiary, Shanghai…
NEW YORK and SUZHOU, China, Nov. 11, 2026 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited ("Accro Bioscience" or "Accro") today announced that its partner's subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial Development", a controlled subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., "Fosun Pharma"), has completed the enrollment of the first patient in a Phase II/III adaptive seamless design clinical trial evaluating AC-201 tablets (Fosun R&D code: FXS5626) for the treatment of non-segmental vitiligo.
The clinical trial received investigational new drug (IND) clearance from China's National Medical Products Administration (NMPA) in September 2026. According to the study design, the Phase II stage plans to enroll 120 patients with non-segmental vitiligo, with the primary objective of evaluating the efficacy of different doses of AC-201 at Week 24.
Vitiligo is a chronic autoimmune depigmenting disorder, with non-segmental vitiligo representing the most prevalent subtype. Characterized by early age of onset and a protracted clinical course, lesions frequently manifest on highly visible areas such as the face, neck, and hands. Patients bear a profound psychosocial burden, and substantial clinical unmet needs remain.
In addition, clinical development of AC-201 for other indications is actively progressing: a Phase II clinical trial in China for moderate-to-severe plaque psoriasis has been completed, and a Phase II clinical trial for non-infectious uveitis (NIU) is currently ongoing in China.
Dr. Xiaohu Zhang, CEO of Accro Bioscience, stated: "Following clinical trial clearance in September, Fosun Pharma achieved rapid first-patient enrollment for AC-201, demonstrating exceptional execution efficiency and strategic synergy across our teams. Vitiligo represents another primary indication, leveraging our progress in psoriasis and uveitis.
AC-201 is a novel, highly selective and potent oral small-molecule inhibitor…
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