On April 20, Hengrui Medicine issued an announcement stating that it had recently received approval from the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" for ivabradine hydrogen sulfate sustained-release tablets, and clinical trials will be launched in the near future.
Indications: This product is suitable for NYHAII～IV chronic heart failure patients with sinus rhythm, heart rate ≥70 beats/min, and cardiac systolic dysfunction.
It is used in combination with standard treatment including β-blockers, or used When contraindicated or cannot tolerate β-blocker treatment.
Ivabradine is a pure heart rate-lowering drug, which reduces the heart rate by selectively and specifically inhibiting the If current of cardiac pacing.
Ivabradine was originally made into tablets in the form of hydrochloride, and it was first listed in France in October 2005.
The application company was French Servier with the trade name Procoralan/Corlentor; it was listed in the United States in April 2015.
The applicant company is Amgen of the United States, the trade name is Corlanor; in 2015, the State Food and Drug Administration approved the import of French Servier Ivabradine hydrochloride tablets (trade name: Corlanor).
Upon inquiry, similar products in Europe, such as Ivabradine Anpharm and Ivabradine Accord, have been approved.
At present, only Les Laboratoires Servier's ivabradine hydrochloride tablets are on the market.
Hengrui Medicine has developed a single and stable ivabradine bisulfate, and there is no sustained-release ivabradine bisulfate tablet on the market at home and abroad.
Upon inquiry, the global sales of ivabradine tablets in 2019 were US$379 million.
Up to now, Hengrui Pharmaceuticals has invested approximately RMB 50.
94 million in research and development related projects related to ivabradine hydrogen sulfate.