Innovent throws its hat further into China's GLP-1 ring
Innovent Biologics is planning a second filing for its dual GLP-1/glucagon agonist mazdutide in China, as it tries to carve out a share of a market currently dominated by Novo Nordisk and Eli Lilly.
Mazdutide – a once-weekly injectable Innovent licensed from Lilly – was submitted to China's National Medical Products Administration (NMPA) earlier this year for weight management in the overweight and obese, and will soon be submitted for type 2 diabetes as well after a second positive phase 3 trial, said Innovent.
Novo Nordisk's GLP-1 agonist Ozempic (semaglutide) has been available in China for diabetes since 2021, and the Wegovy formulation for obesity got the green light from the NMPA last month.
Lilly, meanwhile, has been selling its GLP-1 agonist Trulicity (dulaglutide) in China since 2019, while its dual GLP-1/GIP agonist tirzepatide was approved for diabetes in May and for obesity just last week. Outside China, the tirzepatide products are known as Mounjaro and Zepbound, respectively.
China is the world's second-largest economy, the second-largest pharma market after the US, and the country estimated to have the highest number of overweight or obese people, so it is a key target for all drugmakers with weight-loss products.
Some estimates predict the number of overweight adults in China will reach 540 million by 2030 - more than the entire population of the EU and UK combined.
Innovent, which has operations in Suzhou and San Francisco, said this morning that its placebo-controlled DREAMs-1 trial of mazdutide in Chinese adults with type 2 diabetes inadequately controlled by diet and exercise alone had met the primary endpoint and all key secondary endpoints.
The main endpoint in the study was the change from baseline at 24 weeks in glycated haemoglobin (HbA1c) levels, a biomarker for blood glucose control.
The positive result comes after the DREAMS-2 study was shown to be superior to dulaglutide in maintaining blood glucose levels, with additional benefits, including weight loss and cardiometabolic benefits, compared to the control drug. Now, Innovent has said it plans to file for NMPA approval of the drug in diabetes "in the near term."
"Mazdutide is the first and fastest-developed [GLP-1/glucagon] dual agonist in the world," said Dr Lei Qian, head of clinical development at Innovent.
He added that the next major readout for the programme will come from DREAMS-3, a head-to-head study with semaglutide in Chinese adults with early type 2 diabetes and obesity. Lilly's R&D pipeline reveals that mazdutide is in phase 2 outside China.
Meanwhile, other companies looking at combined GLP-1/glucagon agonists include Boehringer Ingelheim and Zealand Pharma, whose survodutide candidate is in phase 3 testing. Lilly, meanwhile, is developing a triple receptor agonist, retatrutide, that targets GLP-1, GIP, and glucagon and is also in phase 3.
