On November 8th, according to the official website of China CDE, Haisco Pharmaceutical's 3 generic drug ranolazine sustained-release tablets declared for listing (acceptance number: CYHS2101986/7).

Ranolazine was developed by Gilead and is the first drug approved by the FDA for the treatment of chronic angina pectoris in the past decade. It was approved for marketing in the United States in 2006 for the first-line treatment of symptomatic patients with chronic angina pectoris.

Clinical data shows that ranolazine can be used as a single-agent therapy or as an adjuvant drug for other anti-angina pectoris; for chronic stable angina pectoris, it can relieve symptoms and improve exercise tolerance. Different from existing anti-angina pectoris drugs, ranolazine is a partial fatty acid oxidase inhibitor that has no effect on heart rate and blood pressure. It can effectively relieve angina pectoris without changing other kinetic parameters of the drug and improve the quality of life of patients with angina pectoris.

According to the Insight database, ranolazine global sales reached a peak of US$758 million in 2018. However, the entry of generic drugs in the US market in 2019H1 led to a cliff-like decline in sales.

Ranolazine has not yet been marketed in China. In view of the large number of patients suffering from angina pectoris, and the product is recommended for treatment of angina pectoris by relevant foreign guidelines, it has a good market prospect. According to the Insight database, Yangtze River Pharmaceuticals in China is also conducting BE trials. In addition, Qingfeng Pharmaceuticals and Sihuan Pharmaceuticals are undergoing phase II clinical trials, and Furen Pharmaceuticals is undergoing phase I clinical trials.