Riociguat

Pulmonary arterial hypertension is a rare pulmonary vascular disease with rapid progression and poor prognosis. Previous treatment methods mostly focused on pathways such as endothelin and prostacyclin, which still have the limitation of poor clinical response. Riociguat is the world's first anti-pulmonary hypertension drug of soluble guanylate cyclase (sGC) agonist class. By activating sGC and up-regulating the level of cyclic guanosine monophosphate, it can simultaneously dilate pulmonary vessels and inhibit vascular remodeling. It is the only oral therapeutic drug currently approved for both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), which can significantly improve the exercise tolerance of patients and reduce the risk of clinical deterioration, providing a brand-new intervention path for the two groups of pulmonary hypertension patients who lack more treatment options.

At present, the global market size of riociguat is approximately USD 1.2 billion. Driven by the improvement of the diagnosis rate of pulmonary hypertension and the expansion of the coverage of the indication population, the compound annual growth rate in the past five years has remained at around 6%. In terms of the Chinese market, after riociguat was included in the national medical insurance catalog in 2022, the payment threshold for patients has been greatly reduced, and the market size has rapidly climbed to approximately RMB 120 million, with a three-year compound growth rate of more than 45%. At present, the domestic preparation market is still dominated by the original research drug, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the gradual launch of generic products after the expiration of the patent, the market accessibility will be further improved.

The original research enterprise of riociguat is Bayer of Germany, and the original trade name is "Adempas". Its Chinese compound patent will expire in 2027. The dosage form approved by the original research in China is tablet, with specifications including 0.5mg, 1mg, 1.5mg, 2mg and 2.5mg, which has been included in the Chinese Listed Drug Catalogue as the reference preparation. At the API level, the riociguat API of the original research enterprise Bayer has completed the registration of marketing application at CDE (status A). 6 domestic enterprises have submitted registration applications for riociguat API, among which 3 have been approved to be in status A. In terms of preparations, in addition to the original research drug, 2 domestic enterprises have had their generic drugs approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of riociguat impurity reference standards, covering all types such as process impurities and degradation impurities. Most products can be supplied from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the whole process of API and preparation R&D and quality control.