Qilu Pharmaceutical Secures China's First Generic Approval for Riociguat, a $900M+ Pulmonary Arterial Hypertension Drug
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On October 8, according to the latest announcement on the NMPA official website,Qilu PharmaceuticalDeclaredRiociguat TabletsApproved for marketing andDeemed to have passed the consistency evaluation, this product is the first to be approved for marketing. TargetingRiociguat，Merck and Bayer have strategically cooperated in promotion, with global sales exceeding 900 million US dollars in 2023.
RiociguatThe original research isBayer/MSDA jointly developed soluble guanylate cyclase（sGC）Agonist, indicated for the treatment of chronic thromboembolic pulmonary hypertension.（CTEPH）And Arterial Pulmonary Hypertension（PAH）. Approved by the FDA for marketing in 2013, used for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. According to the PharmaOcean database,RiociguatExceeding $900 million in global sales in 2023.Riociguat TabletsIn 2023, the sales revenue in Chinese hospitals exceeded 60 million, with a year-on-year increase of 33.37%.
RiociguatEntered the Chinese market in September 2017 and has now been included in the Class B medical insurance directory through negotiation. The 2023 medical insurance directory contains only seven targeted drugs for pulmonary arterial hypertension.RiociguatOne of them. According to the PharmaOcean database, previously,Riociguat TabletsOnly the original research product has been marketed in China. This time, Qilu Pharmaceutical Co., Ltd. has successfully obtained approval, securing the first generic drug in China and being the first to pass the evaluation.
RiociguatThe compound patent in China has expired in 2023, according to the PharmaCube database.Riociguat TabletsCurrently, two pharmaceutical companies, Ningbo Meinuohua Tiankang Pharmaceutical and Jiangsu Huayang Pharmaceutical, have submitted applications for the production of Class 4 generic drugs.
From 2024 to present, Qilu Pharmaceutical(Including subsidiaries)Thirty-seven varieties have passed the evaluation, of whichRiociguat Tablets, Carvedilol Tablets, Metformin Empagliflozin Tablets (Ⅵ), Cefpodoxime Proxetil Tablets, Emtricitabine Rilpivirine Tenofovir Alafenamide TabletsNine varieties, including ..., were the first to pass the evaluation.
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