Abstract： Objective:To assess the long-term safety and efficacy of nintedanib in Chinese patients with idiopathic pulmonary fibrosis (IPF).Methods:Eligible patients who completed the INPULSIS trials were included in INPULSIS-ON. After a 4-12 week off-treatment period, patients continued nintedanib (received nintedanib in INPULISIS) or initiated nintedanib (received placebo in INPULSIS) received nintedanib 150 or 100 mg bid. The primary objective was to evaluate the long-term safety of nintedanib in Chinese patients in INPULSIS-ON.Results:Of the 75 Chinese patients who completed the INPULSIS, 68(90.7%) were eligible for entering the INPULSIS-ON (continued nintedanib, n=39; initiated nintedanib, n=29). All patients reported at least one adverse event (AE). Thirty-two (82.1%) patients who continued nintedanib and 22(75.9%) patients who initiated nintedanib reported both severe AEs and serious AEs. Diarrhea was the most common AE (continued nintedanib, 48.7% vs. initiated, 69.0%), followed by lung infection (35.9% vs. 51.7%), nasopharyngitis (41.0% vs. 27.6%), and upper respiratory tract infection (33.3% vs. 27.6%), respectively. The most common AEs that led to permanent treatment discontinuation were respiratory failure (continued nintedanib, 10.3% vs. initiated, 0) and progression of IPF (7.7% vs. 3.8%). The adjusted annual rate of decline in forced vital capacity calculated over 192 weeks was 88.08 ml/year (continued nintedanib, 93.99 ml/year vs. initiated, 79.99 ml/year). Overall, 20.6% of the Chinese patients had at least one acute IPF exacerbation in both trial groups. Conclusions:The long-term safety and tolerability of nintedanib in Chinese patients was manageable and consistent with that in the overall population in the INPULSIS-ON. No new safety signals were identified.