Recently, the National Medical Products Administration issued the latest drug approval certificate, and the tiotropium bromide inhalation powder submitted by Shandong Jingwei Pharmaceutical Co., Ltd. was officially approved for marketing. It also passed the consistency evaluation of generic drug quality and efficacy, becoming the first domestic company to pass the evaluation for this product , filling the industry gap of no domestically produced products that have passed the evaluation for more than ten years since the launch of this blockbuster respiratory product.
As the world's first once-daily long-acting anticholinergic drug, tiotropium bromide inhaled powder is a first-line cornerstone treatment for stable chronic obstructive pulmonary disease (COPD), recommended at the highest level by both the global GOLD COPD guidelines and domestic COPD diagnosis and treatment guidelines, indicating a strong clinical need. The original product, Spiriva by Boehringer Ingelheim, entered the Chinese market in 2005 and has long held a leading position in the domestic COPD drug market. In the domestic generic drug market, Chia Tai Tianqing Pharmaceutical Group obtained the first domestic generic approval for this drug as early as 2009. Subsequently, companies such as Nanchang Hongyi and Zhejiang Xianju also obtained approval for their products. After years of market cultivation, domestic products now account for more than half of the market share. However, due to the complex formulation of inhaled powder, which combines drug and device, there are extremely high technical barriers in areas such as raw material micronization control, formulation process design, drug-device compatibility, and in vitro inhalation performance evaluation. For many years since its market launch, no company has been able to overcome the consistency evaluation, which has become a long-term focus of attention within the industry.
Tiotropium bromide inhalation powder was included in the fifth batch of national centralized procurement as early as 2021. The original manufacturer, Boehringer Ingelheim, Nanchang Hongyi, and Zhejiang Xianju all successfully won bids, and the product price dropped significantly after the centralized procurement was implemented. Affected by the price reduction from centralized procurement, domestic sales of this product declined significantly in 2022. According to data from Yaozhi, after market adjustments and increased sales volume, domestic sales exceeded 800 million yuan in 2024.
Shandong Jingwei's achievement of becoming the first company to pass the consistency evaluation coincides perfectly with a crucial industry juncture. In February 2026, the bidding for the follow-up procurement of the first eight batches of national centralized procurement agreements will commence, and tiotropium bromide inhalation powder will be included in this round of procurement. According to national centralized procurement rules, passing the consistency evaluation is a core entry ticket for companies to participate in national procurement. This first-to-pass achievement not only gives Shandong Jingwei a core competitive advantage in subsequent centralized procurement follow-ups and hospital access, but also opens up space for its rapid expansion into grassroots markets and accelerated domestic substitution. It is worth noting that several leading domestic respiratory formulation companies, such as Health Yuan and Changfeng Pharmaceutical, have already completed the bioequivalence (BE) trials for this product and are in the market application review stage. With the first company passing the evaluation, the window for passing the evaluation for this product has officially opened, and a wave of evaluations is likely to follow. This will completely reshape the market competition landscape for this multi-billion-dollar respiratory chronic disease drug in China.