On September 8, Fosun Pharma (600196.SH; 02196.HK) announced that its controlling subsidiary Fosun Pharma Industrial has received approval from China's National Medical Products Administration (NMPA) to conduct a Phase II/III adaptive seamless design clinical trial of FXS5626 tablets for the treatment of non-segmental vitiligo. FXS5626 is an oral small molecule JAK inhibitor (TYK2/JAK1 dual-target inhibitor) licensed in by the Group, which holds exclusive rights for research, development, production, registration, and commercialization of the drug in mainland China, Hong Kong, and Macau.
FXS5626 (original project code AC-201) is an oral small molecule TYK2/JAK1 dual-target inhibitor, primarily intended for the autoimmune disease field. Vitiligo is a common acquired pigmentary depigmentation skin disorder, with non-segmental vitiligo being the most common type, and its pathogenesis is closely related to autoimmune mechanisms. Currently, treatment options for vitiligo are limited. By inhibiting the JAK-STAT signaling pathway, JAK inhibitors can regulate immune responses and promote melanocyte function recovery, becoming an important R&D direction in the vitiligo treatment field.
As of the announcement date, the Fosun Pharma Group's cumulative R&D investment in FXS5626 is approximately RMB 108 million (unaudited). The approved Phase II/III adaptive seamless design clinical trial can directly enter Phase III based on Phase II data, helping to shorten the R&D cycle and accelerate the product launch process. Fosun Pharma stated that it will conduct the clinical trial in mainland China once all conditions are met. In recent years, Fosun Pharma has continued to布局 in the autoimmune disease field, and in addition to FXS5626, it also has multiple autoimmune pipeline products at different R&D stages.

Source: Fosun Pharma Announcement / Sina Finance | https://www.fosunpharma.com/news/?20250527=UXXZL.scm