Competition

China approves Sciwind's ecnoglutide for weight management after diabetes clearance

A new GLP-1 medicine is now cleared in China for weight loss, but it is not approved in the United States and no US filing has been reported.

By the Semaglutides news desk·
China approves Sciwind's ecnoglutide for weight management after diabetes clearance
Image: biopharminternational.com

China's drug regulator has approved ecnoglutide injection for chronic weight management, adding another GLP-1 medicine to a market that already includes products from Novo Nordisk and Eli Lilly [2][3]. Sciwind Biosciences said the National Medical Products Administration cleared the drug on March 6, 2026, for adults with overweight or obesity [3], about five weeks after approving it for blood sugar control in adults with type 2 diabetes [2].

Ecnoglutide, discovered and developed by Hangzhou-based Sciwind, is described by the company as a long-acting GLP-1 receptor agonist and the first approved "cAMP-biased" GLP-1 receptor agonist for weight management [3]. According to Sciwind, the drug selectively activates the cAMP signaling pathway and minimizes recruitment of a protein called beta-arrestin, which is intended to distinguish it from conventional GLP-1 medicines [3]. BioPharm International described the same mechanism as designed to maintain effectiveness by reducing receptor desensitization [2]. The announcements did not state how often the injection is given.

The approval is based on the Phase 3 SLIMMER trial in Chinese adults with overweight or obesity [3]. At 48 weeks, the 2.4 mg dose produced a mean 15.4% reduction in body weight from baseline, or 15.1% after adjusting for placebo; 92.8% of participants lost at least 5% of body weight, 79.6% lost at least 10%, and 63.5% lost at least 15% [3]. Sciwind said participants in the ecnoglutide groups were still losing weight at week 48 without reaching a plateau [3]. Trial results were published in The Lancet Diabetes & Endocrinology in June 2025 [3].

The trial also measured changes in other heart and metabolic risk factors. Sciwind reported improvements in waist circumference, blood pressure, lipid profile, HbA1c, fasting glucose, insulin levels and insulin resistance, along with a reduction in uric acid of up to 54.3 micromoles per liter [3]. Among participants whose liver fat was at least 8% at the start, liver fat fell by a mean of 53.1% at week 40 in the 2.4 mg group, and all doses reduced liver enzyme levels more than placebo [3].

"Following 48 weeks of treatment, the Ecnoglutide group achieved a 15.4% reduction in body weight, and 92.8% of patients attained clinically meaningful weight loss," said Dr. Linong Ji, principal investigator of the SLIMMER trial [3].

Under a collaboration announced in February 2026, Pfizer's China division obtained exclusive rights to commercialize ecnoglutide in mainland China, while Sciwind remains the marketing authorization holder responsible for research and development, regulatory filings, manufacturing and supply [2]. Sciwind could receive up to $495 million in upfront payments and milestone-based compensation tied to regulatory and commercial performance [2]. "The collaboration represents another solid step to advance Pfizer's global strategy in the metabolic field," said Alexandre de Germay, Pfizer's chief international commercial officer [2].

Why it matters for patients

Ecnoglutide is approved only in China. It is not FDA-approved, and no application for US approval has been reported. People in the United States cannot get this drug through normal channels.

It is also not the same molecule as semaglutide (sold as Ozempic, Wegovy and Rybelsus) or tirzepatide (sold as Mounjaro and Zepbound), so its approval does not change the label or supply of those products.

The 15.1% placebo-adjusted weight loss figure comes from a placebo-controlled trial in Chinese adults, not a head-to-head study against another GLP-1 medicine. Weight-loss percentages from separate trials of different drugs are not directly comparable, because the studies enrolled different patients and used different designs. Sciwind characterized its results as numerically higher than those seen with non-biased GLP-1 therapies in similar populations, which is the company's own comparison [2].

The announcement states that ecnoglutide has shown a favorable safety profile from Phase 1 through Phase 3 trials [3], but it does not give rates of specific side effects. How a broader group of patients outside China would respond has not been reported.

BioPharm International noted that the approval intensifies competition in the global GLP-1 market [2]. Whether that competition affects US prices or availability has not been established.

What happens next

Pfizer China will handle commercialization in mainland China, but launch timing and pricing there have not been disclosed [2].

China's approval for type 2 diabetes was dated January 30, 2026, and the weight management approval was dated March 6, 2026 [2][3]. Whether Sciwind plans to seek approval in the United States or in other countries has not been reported.

Images from the sources

China approves Sciwind's ecnoglutide for weight management after diabetes clearance
biopharminternational.com

Sources

  1. https://www1.hkexnews.hk/app/sehk/2026/108322/documents/sehk26032301281.pdf
  2. https://www.biopharminternational.com/view/china-approval-of-ecnoglutide-expands-competition-in-the-glp-1-obesity-market
  3. https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html

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