Novo Nordisk Submits Five Import Clinical Applications for Semaglutide to Accelerate China Launch

By Xiao Yaowan

On December 12, the official website of the Center for Drug Evaluation (CDE) showed that Novo Nordisk simultaneously submitted five import clinical trial applications for its diabetes drug Semaglutide injection. As a blockbuster GLP-1 receptor agonist, and with China being one of the most important markets for the company’s global diabetes franchise, Novo Nordisk aims to accelerate the early market launch of semaglutide in China through registrational studies conducted domestically.

Blockbuster GLP-1 Receptor Agonist

In 2018, the global market for diabetes medications was valued at approximately $45 billion, with a year-on-year growth rate of only 1.5%. Against this backdrop of sluggish overall growth, the global market for GLP-1 receptor agonists and combination products reached approximately $8.827 billion, achieving a compound annual growth rate (CAGR) of 35.7%. This growth rate significantly exceeded that of the overall diabetes medication market and the injectable antidiabetic drug segment, establishing these therapies as the primary growth engine for the entire diabetes medication market.

These agents offer multiple clinical advantages, including potent glucose-lowering efficacy, a low risk of hypoglycemia, weight loss benefits, and cardiovascular benefits, making them highly promising antidiabetic medications.

Currently, eight GLP-1 receptor agonist products have been approved for marketing worldwide, including one oral formulation. Semaglutide injection is a long-acting GLP-1 receptor agonist developed by Novo Nordisk. Known in Chinese as Semaglutide Injection, it was approved by the FDA in November 2017. Marketed under the brand name Ozempic, it is used in conjunction with diet and exercise to help patients with type 2 diabetes control their blood glucose levels.

Novo Nordisk’s financial report shows that in the first three quarters of 2019, global sales of Ozempic (semaglutide injection) reached $1.014 billion, rapidly entering the ranks of blockbuster drugs within less than two years of its launch.

Impressive Performance in the Chinese Market

According to the financial reports disclosed by Novo Nordisk, the company's global sales amounted to approximately USD 13.215 billion in the first three quarters of 2019. Among this, the mainland China market contributed sales of approximately RMB 10.14 billion, accounting for 10.96% of the global sales performance, with a sales growth rate reaching 15%.

In terms of specific product categories, the best-selling products in mainland China currently include insulin, insulin analogs, and GLP-1 receptor agonists. According to comprehensive statistics, Novo Nordisk’s diabetes medications account for 27.8% of the Chinese diabetes market share.

Notably, as Novo Nordisk’s only GLP-1 receptor agonist marketed in China, Victoza (liraglutide injection) saw its sales increase by 69%, capturing a 92.4% share of the domestic GLP-1 receptor agonist market.

# Increasing Investment in the Chinese Market

As a pharmaceutical company with nearly a century of focus on diabetes medications, Novo Nordisk has been present in the Chinese market for 25 years. Benefiting from the continuous optimization of China’s pharmaceutical regulatory environment and the development opportunities brought about by healthcare reforms, Novo Nordisk has achieved rapid growth in China. Looking ahead, China remains a strategic market where Novo Nordisk is intensifying its investment and expansion.

At the Second China International Import Expo held in Shanghai in early November, Novo Nordisk participated again under the theme “Transforming Diabetes, Healthy China Dream,” with several innovative products making their debut.

Centering on semaglutide, Novo Nordisk showcased Ozempic (semaglutide injection) and Rybelsus (oral semaglutide), both of which are global blockbuster innovative drugs expected to enter the Chinese market soon. Ozempic is a once-weekly semaglutide injection, while Rybelsus is the oral semaglutide approved by the FDA for marketing this September. As the world’s first oral GLP-1 receptor agonist, Rybelsus is poised to disrupt the current market landscape of GLP-1 receptor agonists, leveraging superior patient adherence and efficacy advantages.

Registration Progress of Semaglutide in China

Regarding the registration progress of semaglutide in China, since September 2016, the Center for Drug Evaluation (CDE) has successively approved two clinical trials for semaglutide injection, both of which have been completed, including one Phase I clinical trial and one Phase III clinical trial. Recently, Novo Nordisk submitted five import clinical trial applications at once, aiming to accelerate preparations for the registration studies of semaglutide in China. For oral semaglutide, Novo Nordisk is currently conducting three clinical trials of semaglutide tablets in China, including one Phase I clinical trial and two Phase III clinical trials, all of which are currently in the recruitment phase.

Source: Chinadrugtrials

Title: Registration | Five Clinical Trial Applications Submitted at Once! Novo Nordisk Accelerates the Launch of Semaglutide in China