Qilu Pharmaceutical Submits First Domestic ANDA for Riociguat Tablets, a Blockbuster Drug with Over $1 Billion in Global Sales

On March 25, the CDE website showed that Qilu Pharmaceutical's riociguat tablets had their market application accepted. This is the first generic riociguat to be submitted for marketing in China. It is also the second first-to-file generic drug submission by Qilu within a week (Recommended reading: First-to-File! Qilu Pharmaceutical’s "Romiplostim" Submitted for Marketing).

Riociguat is a soluble guanylate cyclase (sGC) agonist, jointly developed by Bayer/MSD, and was first approved for marketing in the United States in 2013 under the trade name Adempas. Its original drug was granted marketing approval by the National Medical Products Administration (NMPA) in September 2017 through the priority review process for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and arterial pulmonary hypertension (PAH).

According to the financial reports of Bayer and Merck & Co., Inc., this drug generated sales revenue of 738 million euros for Bayer and 252 million US dollars for Merck & Co., Inc. in 2021.

In China, companies currently developing the riociguat generic drug include, besides Qilu Pharmaceutical, Zhengzhou Deep Blue Ocean Biomedical Technology and Huawei Medicine.

According to Bayer's financial report, the compound patent for Riociguat will expire in China in 2023. A query on China's listed drug patent information registration platform shows that Qilu Pharmaceutical has not yet registered a patent declaration for this product.