Accro Bioscience Announces First Patient Enrolled in Phase II/III Clinical Trial of Highly Selective TYK2/JAK1 Inhibitor AC-201 for Non-Segmental Vitiligo

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. We look forward to working closely with Fosun Pharma to bring this novel oral therapeutic to vitiligo patients as expeditiously as possible."

About AC-201

AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudokinase domain (JH2) of TYK2/JAK1, with minimal effect on the JAK2/JAK2 signaling pathway. It is currently being developed to treat immune mediated inflammatory diseases.

About Accro Bioscience

Accro Bioscience (Suzhou) Limited is a clinical-stage biotechnology company pioneering the discovery, development and commercialization of novel therapeutics for inflammatory and autoimmune diseases, by targeting molecular mechanisms of regulatory cell death. The company's robust pipeline of first- and best-in-class compounds offers the potential for innovative, paradigm-shifting therapies.

About Fosun Pharma

Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem.

Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia.

Looking ahead, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health.

SOURCE Accro Bioscience (Suzhou) Limited