全球研发 | 复星医药自研治疗慢阻肺小分子口服创新药FXS7553完成中国II期临床首例患者给药
（2026年8月13日，中国上海）8月13日，复星医药（600196.SH；02196.HK）宣布，自主研发的用于治疗慢性阻塞性肺疾病（COPD）的DPP-1抑制剂创新药FXS7553于近日在中国境内（不包括港澳台地区）完成II期临床首例患者给药。
FXS7553为复星医药拥有自主知识产权的小分子口服DPP-1抑制剂，其通过抑制DPP-1及其激活的中性粒细胞丝氨酸蛋白酶降低炎症反应，从而阻断感染恶性循环及由此导致的气道结构损伤。截至目前，FXS7553另一项在研适应症用于治疗非囊性纤维化支气管扩张症于中国境内处于II期临床试验阶段。
COPD稳定期治疗的主要目标是减轻症状，减少急性加重和延缓疾病进展。现有标准治疗药物主要是支气管扩张剂和吸入性糖皮质激素，标准治疗可一定程度改善症状，但在预防和减少急性加重，减缓疾病进展上的作用有限。COPD中最常见的是非2型/中性粒细胞性炎症型，占比约60~80%。近20年来，中国仅有三款新作用机制的COPD治疗药物获批，其中两款针对2型炎症；占主导地位的非2型/中性粒细胞炎症表型仍缺乏针对性的治疗选择。截至目前，于中国境内尚无与FXS7553同一分子机制的小分子口服抑制剂获批上市。
Fosun Pharma's Self-Developed Small Molecule Oral Innovative Drug FXS7553 for the Treatment of COPD Successfully Completed Dosed the First Patient in Phase 2 Clinical Trial in China
(13 August, 2026, Shanghai China) On August 13, Fosun Pharma (600196.SH; 02196.HK) announced that its self-developed DPP-1 inhibitor innovative drug FXS7553 for the treatment of chronic obstructive pulmonary disease (COPD) has recently completed the first patient dosing in a Phase 2 clinical trial in Chinese mainland (excluding Hong Kong SAR, Macau SAR, and Taiwan region).
FXS7553 is a small molecule orally administered DPP-1 inhibitor independently developed by Fosun Pharma. It reduces neutrophilic inflammatory responses and mitigates the consequent airway damage by inhibiting DPP-1-mediated activation of neutrophil serine proteases. As of now, another under-development indication of FXS7553 for the treatment of non-cystic fibrosis bronchiectasis is under Phase 2 clinical trial stage in Chinese mainland.
The primary goals of stable COPD treatment are to alleviate symptoms, reduce acute exacerbations, and slow disease progression. Current standard treatments, primarily bronchodilators and inhaled corticosteroids, can relieve symptoms to a certain extent but have limited efficacy in preventing acute exacerbations or slowing disease progression. Neutrophilic inflammation represents the predominant inflammatory phenotype in COPD, affecting the majority of patients. Over the past two decades, only three novel mechanism-based therapies have been approved for COPD in China, two of which target type 2 inflammation, leaving the predominant non-type 2/neutrophilic inflammatory phenotype without targeted treatment options. To date, no small-molecule oral inhibitor with the same molecular mechanism has been approved for marketing in China.
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