复星医药FXS5626获批II/III期临床，自免管线再进一步

（2026年9月8日，中国上海） 9月8日，复星医药（股票代码：600196.SH；02196.HK）宣布，口服小分子JAK抑制剂（TYK2/JAK1双靶点抑制剂）FXS5626片用于治疗非节段型白癜风的II/III期适应性无缝设计临床试验获得国家药监局批准，公司将在各项条件齐备后，于中国境内推进该适应症的相关临床研究工作。

FXS5626 是复星医药许可引进的口服小分子JAK抑制剂（TYK2/JAK1双靶点抑制剂），复星医药享有该药品于中国境内、香港及澳门地区研究、开发、生产、注册及商业化的独占权利，产品主要面向自身免疫性疾病领域开发。截至目前，FXS5626用于中重度斑块型银屑病已于中国境内完成II期临床试验、用于非感染性葡萄膜炎于中国境内处于II期临床试验阶段。本次白癜风适应症临床试验获批，是该产品在自身免疫性疾病领域的又一重要进展。

根据IQVIA CHPA最新数据[1]，2025年，JAK抑制剂于中国境内的销售额约为人民币19.80亿元。截至目前，中国境内尚无TYK2/JAK1双靶点抑制剂获批上市。

复星医药持续聚焦肿瘤、免疫炎症、神经退行性疾病等核心治疗领域，不断丰富创新管线。FXS5626 多适应症临床工作稳步推进，进一步强化了公司在免疫炎症领域的产品矩阵。

[1] 由IQVIA提供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商；IQVIA CHPA数据代表中国境内100张床位以上的医院药品销售市场，不同的药品因其各自销售渠道布局的不同，实际销售情况可能与IQVIA CHPA数据存在不同程度的差异。

(8 September 2026, Shanghai China )—On 8 September, Fosun Pharma (“the Company”, stock code: 600196.SH; 02196.HK) announced that it has received the approval from the National Medical Products Administration (NMPA) for the Phase 2/3 adaptive seamless design clinical trial of FXS5626 for the treatment of non-segmental vitiligo. Fosun Pharma Industrial intends to commence the relevant clinical trial of the drug in Chinese mainland when the conditions are fulfilled.

FXS5626, an oral small-molecule JAK inhibitor (dual TYK2/JAK1 inhibitor) licensed in by Fosun Pharma, grants the company exclusive rights to research, develop, manufacture, register, and commercialize the drug candidate in Chinese mainland, Hong Kong SAR and Macau SAR. FXS5626 is primarily indicated for autoimmune diseases. As of the date of this announcement, the Phase 2 clinical trial of the drug for moderate-to-severe plaque psoriasis has been completed in China, and the drug for non-infectious uveitis is at the stage of Phase 2 clinical trial in China. The clinical trial approval for the vitiligo indication marks another significant progress for this product in the autoimmune disease field.

According to the latest data of IQVIA CHPA[1], the sales of JAK inhibitors in China in 2025 was approximately RMB 1,980 million. As of now, no TYK2/JAK1 dual-target inhibitor has been approved for marketing in China.

Fosun Pharma continues to focus on core therapeutic areas such as oncology, immuno-inflammation, and neurodegenerative diseases, steadily enriching its innovative pipeline. The steady progression of multi-indication clinical development for FXS5626 further strengthens the company’s product matrix in the immuno-inflammation sector.

[1] Provided by IQVIA, a provider of professional medical and health information and strategic consultation service in the world; IQVIA CHPA data cover the drug sales market of hospitals with more than 100 beds in China, the actual sales of different drugs may vary from the IQVIA CHPA data to varying degrees due to their different sales channels.

媒体：pr@fosunpharma.com

投资人：ir@fosunpharma.com