First Generic Dapagliflozin Approved in China: Luyang Pharmaceutical and Fuyuan Pharma Receive Simultaneous NMPA Approval

On October 28, the latest approval documents from the NMPA showed that dapagliflozin from Shandong Lukang Pharmaceutical Co., Ltd. and Beijing Front Pharmaceutical Co., Ltd. were simultaneously approved for marketing. Previously, only the originator's dapagliflozin had been approved in China, and this approval finally marks the market entry of the first generic version of the product.

Dapagliflozin is an SGLT2 inhibitor antidiabetic drug developed by AstraZeneca. SGLT2 inhibitors inhibit the reabsorption of glucose in the renal tubules, promoting its excretion in the urine and thereby lowering blood glucose concentrations. As this glucose-lowering mechanism is insulin-independent, SGLT2 serves as a novel therapeutic target for diabetes, characterized by a low risk of hypoglycemia, the ability to reduce body weight and blood pressure, and additional cardiovascular benefits, providing a new breakthrough for the development of next-generation antidiabetic medications.

In 2014, dapagliflozin was first approved by the FDA for marketing. It has currently been approved for three indications: type 2 diabetes mellitus, heart failure, and heart failure with reduced ejection fraction. In March 2017, dapagliflozin was first approved for import and launched in China. The drug has currently been included in Category B of the National Reimbursement Drug List through medical insurance negotiations, with a reimbursement price of RMB 2.56 (5 mg/tablet) and RMB 4.36 (10 mg/tablet).

Dapagliflozin is one of AstraZeneca's blockbuster drugs. The Insight database shows that its global sales reached $1.959 billion in 2020, representing a year-on-year increase of 27%.

Dapagliflozin Historical Annual Sales

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

Regarding the competitive landscape of generic drugs in China, there are currently 24 generic pharmaceutical companies developing dapagliflozin. In addition to Lukang Pharmaceutical and Front Pharmaceutical, which were approved today, other companies in China such as Hansoh, Chengdu Better, and Shuanglu Pharmaceutical have filed for marketing approval; five companies, including Nanjing Tianqing, have already entered the bioequivalence (BE) trial stage.

Dapagliflozin Competitive Landscape (Insight)

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