Key Points :
Sciwind is negotiating with a U.S. biotech firm for the out-licensing of its GLP-1 drug, ecnoglutide, to provide obesity and diabetes treatment.
Clinical trial weight loss results are on par with Novo Nordisk’s Wegovy.
Market introduction in the U.S. is expected in about three years, with FDA requirements pending.
Key Background :
Sciwind Biosciences is among a number of Chinese pharma companies looking to compete in the booming global market for obesity medications. Its flagship drug, ecnoglutide, has announced promising Phase 3 trial results with weight loss on par with established treatments like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. An upside of ecnoglutide over most experimental drugs is that extensive clinical testing of the drug has already occurred in China, and more trial data are available from Australian clinical trials.
CEO Pan Hai of the firm believes that the solid clinical foundation could place the drug on a fast track into the US market. The discussions with an American partner are now targeting licensing ecnoglutide for non-weight loss indications. The partner would do the further development, regulatory approvals, and future commercialization. While the deal is not yet signed, both sides believe in the drug’s potential.
Although the proof of concept has been promising based on trial results, Sciwind now faces the daunting and usually lengthy process of securing FDA approval. Bridging studies, which are commonly needed to provide assurance that clinical trial data derived from non-U.S. populations can be applied to American patients, might lengthen the time. However, Sciwind is estimating a possible three-year market launch, provided a fairly untroubled regulatory process ensues.
Domestic, Sciwind has already applied for regulatory approval to market ecnoglutide for the treatment of obesity and type 2 diabetes. Pan Hai stated that the drug will be priced competitively but that the company would not want to fight a “price war” in China’s growing GLP-1 drug market, which already has multinational leaders’ drugs.
Sciwind is not taking a breather in the United States and China. The company is aggressively looking for strategic partners in Latin America and the Middle East, hoping to spread its wings further around the world. This multi-region strategy can help the company tap into untapped medical needs in emerging markets, where cost-effective substitutes of drugs like Wegovy are in great demand.
If this succeeds, Sciwind’s expansion may alter the competitive landscape in the GLP-1 receptor agonists market by introducing a new, global player from China into an industry that is presently dominated by Western pharma companies.
