New York and Suzhou, China, September 8, 2026
Accro Bioscience has announced a major clinical development milestone for AC-201, an investigational oral TYK2/JAK1 inhibitor, after its partner Shanghai Fosun Pharmaceutical Industrial Development Company received clearance from China’s National Medical Products Administration (NMPA) to conduct a Phase II/III adaptive seamless clinical trial in patients with non-segmental vitiligo. The regulatory decision advances AC-201 into a later-stage clinical program targeting an autoimmune dermatological condition characterized by loss of pigmentation. Fosun Pharma Industrial plans to initiate the clinical trial in mainland China once the necessary conditions are met.
NMPA Clearance Advances AC-201 Toward Phase II/III Development
The NMPA clearance represents an important step in the development of AC-201 tablets, also known as FXS5626 under Fosun Pharma’s development program. The planned study will use an adaptive seamless Phase II/III design, allowing clinical development to progress within an integrated protocol while evaluating the candidate’s safety and therapeutic potential in non-segmental vitiligo. Importantly, the regulatory action is an IND clearance to conduct clinical research, not an approval of AC-201 for the treatment of vitiligo. The clinical trial itself is expected to begin in mainland China after the required conditions are satisfied. The development is being conducted through the partnership between Accro Bioscience and Fosun Pharma, with Fosun Pharma Industrial responsible for the China clinical program. The collaboration gives Fosun rights to develop and commercialize AC-201 in Greater China, while Accro retains rights outside mainland China, Hong Kong and Macau. The partnership provides a pathway for Accro’s investigational immunology program to advance into later-stage clinical development in China.
Selective TYK2/JAK1 Mechanism Targets Immune Signaling
AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2 and JAK1. According to Accro, the candidate binds to the JH2 pseudokinase domain of TYK2/JAK1 and is designed to exert minimal effects on JAK2 signaling. The company is developing AC-201 for a range of immune-mediated inflammatory diseases, with non-segmental vitiligo representing an important expansion of its clinical development strategy. The selective mechanism is relevant because TYK2/JAK signaling plays an important role in immune and inflammatory pathways implicated in autoimmune disorders. In vitiligo, immune-mediated destruction of melanocytes results in areas of depigmented skin. The advancement of selective oral therapies is therefore an area of active pharmaceutical research as developers seek treatments capable of modulating disease-driving immune pathways while maintaining an appropriate safety profile. AC-201 has also generated clinical development experience in other inflammatory indications. The candidate has been studied in plaque psoriasis, providing an existing clinical foundation for further investigation. However, data from those studies should not be interpreted as evidence of efficacy in vitiligo because the newly cleared NMPA program will need to establish AC-201’s safety and efficacy specifically in the non-segmental vitiligo population.
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Phase II/III Program Could Expand AC-201’s Clinical Potential
The move into a Phase II/III clinical trial positions AC-201 for potentially accelerated evaluation in non-segmental vitiligo. The adaptive seamless design is intended to integrate clinical development stages and generate evidence needed to determine whether the investigational therapy can deliver meaningful benefits for patients. For Accro Bioscience, the milestone represents further progress in translating its immune-modulating small-molecule platform into clinical development. For Fosun Pharma, the program adds another investigational therapy to its broader focus on immunology and inflammation. As the trial progresses, future clinical data will be important for determining AC-201’s efficacy, safety and potential differentiation from existing and emerging treatments for vitiligo. AC-201 remains investigational and is not approved for vitiligo by the NMPA or other regulatory authorities.
Source: Accro Bioscience (Suzhou) Limited press release
