Pirfenidone

Idiopathic pulmonary fibrosis, as a chronic and progressive interstitial lung disease, has a median survival of only 2 to 3 years after diagnosis, and there has been a long-term lack of effective intervention methods clinically. The advent of pirfenidone has broken this dilemma. As the world's first approved small-molecule multi-target anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis, it can inhibit the synthesis and release of pro-fibrotic factors such as transforming growth factor-β and platelet-derived growth factor, reduce fibroblast proliferation and extracellular matrix deposition, and also have anti-inflammatory and anti-oxidant effects. It is indicated for adult patients with mild to moderate idiopathic pulmonary fibrosis, and can significantly delay the decline rate of forced vital capacity of patients, reduce the risk of acute exacerbation, and prolong survival time.

The global pirfenidone market size exceeded USD 1.2 billion in 2023, with a compound annual growth rate maintained at around 8%. The growth momentum mainly comes from the year-by-year increase in the global prevalence of idiopathic pulmonary fibrosis and the improvement of clinical drug penetration in emerging markets. In terms of the Chinese market, after pirfenidone was included in the National Medical Insurance Catalog in 2021, the terminal market size grew rapidly from RMB 520 million in 2020 to RMB 1.47 billion in 2023. At present, generic drugs from multiple domestic enterprises have been approved for marketing, and the market competition pattern has shifted from exclusive original research to a situation where original research and generics co-occupy the market. The overall price has dropped by more than 60% compared with that before the inclusion in medical insurance, and the accessibility of drugs for patients has been greatly improved.

The original research enterprise of pirfenidone is Shionogi & Co., Ltd. of Japan, and the original brand name is Etuary. The core compound patent of the original drug expires in 2018 in major markets such as the United States, Europe and Japan, and the compound patent expires in 2017 in China. The approved dosage form of the original drug is capsule, with specifications including 100mg, 200mg and 267mg. It has been included in the Chinese Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. In terms of domestic API registration, more than 15 enterprises have completed the registration of pirfenidone APIs in CDE with the status of A (approved for use in marketed preparations) at present. Multiple domestic enterprises including the original research enterprise have obtained approval for the marketing of pirfenidone capsules and tablets. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of pirfenidone impurity reference standards, covering all types such as production process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the needs of different stages such as process research, quality research, and registration declaration. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide complete technical documents such as structure confirmation and calibration reports.