China's clears Pfizer GLP-1 ecnoglutide for weight loss

Pfizer has claimed its first regulatory approval for a GLP-1 agonist in obesity, getting a green light in China for ecnoglutide, a once-weekly injectable drug licensed from Hangzhou-based Sciwind Biosciences in February.

Ecnoglutide was already approved to treat type 2 diabetes when Pfizer claimed rights to the drug – known locally as Xianweiying – in Mainland China via a deal valued at up to $495 million. The new approval is for use of the "new-generation, cAMP-biased" GLP-1 agonist for long-term weight management in overweight and obese adults, in conjunction with dietary control and increased physical activity.

The market for weight-loss medicines in China has been growing at a rapid pace, driven by rising obesity rates, with a recent report suggesting that more than half of Chinese adults are overweight or obese, a proportion that could swell to two-thirds by 2030, according to World Obesity Federation data.

That rapid growth in eligible patients has made China – the world's second largest pharma market – a key target for developers of new incretin-based weight-loss therapies.

The market is heading for a shake-up, however, as Novo Nordisk is heading for the loss of patent protection for its GLP-1 agonist semaglutide in China before the end of this month, which could be followed by the entry of lower-cost generic alternatives.

Other incretin drugs approved for weight loss in China include Eli Lilly's dual GIP/GLP-1 agonist tirzepatide, Lilly/Innovent's GCG/GLP-1 agonist mazdutide, and Benemae Pharma's GLP-1 agonist beinaglutide, along with Novo Nordisk's older GLP-1 drug liraglutide and generic versions.

In the phase 3 SLIMMER trial published in The Lancet Diabetes & Endocrinology last year, ecnoglutide achieved weight loss of 15.1% at 48 weeks, with no evidence of a plateauing of effect, along with improvements in waist circumference, blood pressure, lipid profile, HbA1c, fasting glucose, and insulin levels.

According to Sciwind, the 'biased' mechanism differentiates it from other drugs in the class, and – hypothetically at least – can prolong its activity by preventing the drug from being internalised into cells and may reduce side effects like nausea.

Under the terms of its licensing agreement with Pfizer, Sciwind has retained the marketing authorisation for ecnoglutide and is continuing to take the lead on its development, regulatory activities, and manufacturing.

Pfizer's internal efforts to develop weight-loss drugs ran into problems last year, resulting in a trio of discontinued programmes, and it has looked externally to replace them, acquiring Metsera for $10 billion after a bidding war with Novo Nordisk last November.

Image by Gerd Altmann from Pixabay