On October 8, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's Riociguat Tablets have been approved for marketing. This is the first domestically produced generic Riociguat to be approved for sale in China.The original research drug Riociguat, developed jointly by Bayer and Merck, is a soluble guanylate cyclase (sGC) stimulator with a short half-life, requiring three doses per day. Its application in other cardiovascular indications, such as heart failure, is limited. In October 2013, Riociguat was launched in the United States (brand name: Adempas) and entered the Chinese market in September 2017 for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and arterial pulmonary hypertension (PAH).Pulmonary hypertension (PH) is caused by various etiologies and different pathogenic mechanisms, with clinical characteristics showing increased pulmonary vascular resistance and pulmonary artery pressure, which can easily lead to right heart failure or even death. PH can be divided into five types according to the etiology: Pulmonary arterial hypertension (WHO Group I) can be treated with targeted therapy; WHO Groups II and III can benefit from treating underlying diseases; Chronic thromboembolic pulmonary hypertension (WHO Group IV) can be treated surgically to remove thrombus or with targeted therapy. Riociguat is the first drug approved for use in both WHO Group 1 and Group IV pulmonary hypertension.The compound patent for Riociguat in China expired in 2023. According to the PharmaCube database, three companies in China have developed generic versions of Riociguat, including Qilu Pharmaceutical, Zhengzhou Deep Blue Ocean Biomedical Technology, and Huawei Pharmaceutical. Among them, Qilu Pharmaceutical has made the fastest progress and was the first to secure the initial generic approval.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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