Beijing Bai'ao Pharmaceutical's Ivabradine Hydrochloride Tablets Nears Domestic First-to-File Approval

Recently, the official website of the National Medical Products Administration (NMPA) indicates that the marketing authorization application for Beijing Baiao Pharmaceuticals Co., Ltd.'s Class 4 generic drug "Ivabradine Hydrochloride Tablets" has entered the approval review stage (Registration No.: CYHS1900783), and is expected to be approved soon as the first generic in China.

Ivabradine is a pure heart rate-lowering drug that reduces heart rate by selectively and specifically inhibiting the cardiac pacemaker If current. Initially formulated as hydrochloride tablets, it was first marketed in France in October 2005, with Servier (France) as the applicant, under the brand names Procoralan/Corlentor. It was launched in the United States in April 2015, with Amgen as the applicant, under the brand name Corlanor. In 2015, the State Food and Drug Administration approved the import of ivabradine hydrochloride tablets (brand name: Corlentor) from Servier (France).

Currently, only the originator product, Ivabradine Hydrochloride Tablets, is commercially available in China. Data from the Insight database indicates that generic versions of this drug from three domestic pharmaceutical companies are currently under marketing approval review. Hengrui’s 「Ivabradine Bisulfate Tablets」 received marketing approval in Germany and the Netherlands in June 2019. Additionally, Hengrui is developing a sustained-release formulation of this active ingredient as a modified new drug, which has already advanced to Phase III clinical trials.

Source: Insight Database (http://db.dxy.cn/v5/home/)

Beijing Baiao Pharmaceuticals Co., Ltd. was founded by the Chinese Academy of Sciences on January 19, 1995, with a registered capital of RMB 55 million. Located in Changping Park of the Zhongguancun National Independent Innovation Demonstration Zone in Beijing, it is one of the well-known and representative enterprises in the park's "Bioengineering and New Pharmaceuticals Sector." The company currently maintains a portfolio of multiple generic drug products. In February last year, its Valsartan and Amlodipine Tablets achieved first-generic approval and became the first to pass the consistency evaluation.