Novo Nordisk's Liraglutide Gains Momentum in China with Second Indication Nearing Approval

Text | Dopine

On April 30, the status of Novo Nordisk’s marketing application for liraglutide injection (brand name: Victoza; acceptance number: JXSS1800030) with the National Medical Products Administration (NMPA) was updated to “Under Review.” Based on the approved indications for liraglutide abroad and the clinical trials conducted in China, the author speculates that the indication sought in this application is the reduction of cardiovascular event risk in patients with type 2 diabetes.

Liraglutide is a glucagon-like peptide-1 (GLP-1) analog developed by Novo Nordisk. It was approved by the FDA in 2010 for the treatment of adults with type 2 diabetes under the brand name Victoza. In 2017, it received FDA approval to reduce the risk of myocardial infarction, stroke, and cardiovascular death in patients with type 2 diabetes. In June 2019, the FDA further expanded its indications to include the treatment of patients aged 10 years and older with type 2 diabetes.

Furthermore, clinical trials have demonstrated the potential of liraglutide for weight loss and improvement of obesity-related comorbidities. In 2014, Novo Nordisk launched Saxenda (liraglutide, 3 mg), an injectable formulation for weight management, making it the only GLP-1 analog currently approved for weight loss.

To date, Victoza has been approved in more than 100 countries worldwide, with over 1.2 million patients with type 2 diabetes treated. Since its market launch, global sales of liraglutide have risen year by year, peaking in 2018 at approximately DKK 24,333 million. However, due to competition from other glucose-lowering drugs in the same class as well as those with different mechanisms of action, global sales of liraglutide began to decline in 2019 and were surpassed by Eli Lilly’s long-acting GLP-1 analog, dulaglutide.

Liraglutide was approved in China in 2011 under the brand name Victoza. However, due to its high price, sales performance of Victoza in China was not optimistic. In July 2017, Victoza successfully entered the National Reimbursement Drug List through price negotiations, with the price for the 3 mL:18 mg specification reduced to RMB 410 per pen. Following its inclusion in the reimbursement list, Victoza experienced a significant surge in volume starting from the third quarter of 2017 (How much can drug sales increase after being included in the national reimbursement list?), and its sales revenue continued to climb. In 2018, Victoza’s sales revenue grew by 73%, reaching DKK 521 million, accounting for 87% of the domestic GLP-1 market share and 1.3% of the entire diabetes market.

It is worth celebrating that Victoza successfully renewed its inclusion in the 2019 National Reimbursement Drug List. Moreover, the domestic liraglutide market remains exclusively dominated by Novo Nordisk. With the anticipated approval of new indications, liraglutide is expected to achieve new sales highs in the future.

It is reported that the patent for the liraglutide compound expired in China in August 2017, and the crystal patent expired in 2022. However, according to the Insight database, multiple domestic companies have already entered this field. Among them, Jianxiang Biotechnology and Hybio Pharmaceutical have both submitted Class 4 generic drug marketing applications; Chongqing Paijin Biotechnology and Chia Tai Tianqing are conducting bioequivalence (BE) trials; while Guangdong HEC, Tonghua Dongbao, and Hangzhou Jiuyuan Gene Engineering are in Phase III clinical trials. It is expected that with the approval and launch of domestically produced liraglutide, Novo Nordisk’s Victoza will face increasingly fierce competition.

Diabetes increases the risk of heart disease and stroke in patients, while cardiovascular complications, in turn, significantly impact the physical health and life expectancy of individuals with diabetes. It is estimated that approximately 50% of deaths among patients with type 2 diabetes worldwide are caused by cardiovascular diseases. As a country with a large diabetic population, China will see liraglutide further consolidate its position in the domestic diabetes market if it is officially approved in China for reducing the risk of cardiovascular events in patients with type 2 diabetes.

As a global leader in the diabetes field, Novo Nordisk has been continuously launching new glucose-lowering drugs to consolidate its market position. Its glucose-lowering products can be broadly categorized into two main groups: insulin and GLP-1 analogs. Notably, in 2017, Novo Nordisk launched semaglutide injection. Head-to-head data from the SUSTAIN clinical trials demonstrated that semaglutide was significantly superior to dulaglutide, sitagliptin, insulin glargine, or exenatide extended-release in terms of glycemic control and weight reduction, while also offering cardiovascular benefits, making it regarded as the best GLP-1 analog. Furthermore, last year, Novo Nordisk introduced an oral formulation of semaglutide. However, currently, the injectable form of semaglutide is still under review and approval in China and has not yet been officially approved, while the tablet form remains in the clinical trial phase.

References:

[1] Official websites of the CDE and NMPA

[2] Novo Nordisk Financial Report

[3] Insight Database