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Accro Bioscience Announces IND Clearance from NMPA for Phase II/III Clinical Trial of AC-201, a Highly Selective TYK2/JAK1 Inhibitor for the Treatment of Non-Segmental Vitiligo


News provided by

Accro Bioscience (Suzhou) Limited

Sep 08, 2026, 08:20 ET

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NEW YORK and SUZHOU, China, Sept. 8, 2026 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited ("Accro") today announced that Shanghai Fosun Pharmaceutical Industrial Development Company Limited ("Fosun Pharma Industrial"), a subsidiary of its partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"), has received approval from China's National Medical Products Administration (NMPA) to conduct a Phase II/III adaptive seamless design clinical trial of AC-201 tablets (Fosun development code: FXS5626) for the treatment of non-segmental vitiligo. Fosun Pharma Industrial plans to initiate the relevant clinical trial for this indication in mainland China once the necessary conditions are met.

About AC-201

AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudo kinase 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

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