Report: Xianwei is negotiating the authorization of weight loss drugs in the United States

Xianweida is negotiating authorization matters for its weight loss drug in the United States, marking a new breakthrough for domestic weight loss drugs going overseas!

According to a report by Reuters on Friday, domestic biopharmaceutical giant Xianweida is in talks with a U.S. company regarding the authorization of its experimental weight loss drug Ecnoglutide in the United States. The company's CEO, Pan Hai, revealed this news in an interview with Reuters.

According to a late-stage study published in June this year in The Lancet Diabetes & Endocrinology, overweight patients treated with Xianweida's Ecnoglutide lost an average of 10% to 15% of their weight, a result comparable to that of Novo Nordisk's best-selling weight loss drug Wegovy. This drug belongs to the GLP-1 receptor agonist class and works by controlling blood sugar levels and triggering a feeling of fullness.

Pan Hai stated, "We also hope to successfully authorize it, and they will apply for approval in the United States." However, he declined to disclose the specific name of the cooperating company or the financial terms under discussion. Negotiations have not yet entered the detailed contract discussion stage.

This authorization deal is expected to take at least three years to bring the drug to the U.S. market, and the FDA may require bridging studies to compare the pharmacokinetic characteristics of the drug in different patient populations.

Prospects for U.S. Market Authorization

Pan Hai revealed that potential U.S. partners hope to obtain marketing approval in the United States to use Ecnoglutide for the treatment of various medical conditions and will conduct further clinical development. Xianweida hopes that partners can leverage the clinical data accumulated in China and Australia to accelerate the development process.

Currently, the U.S. weight loss drug market is dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound, but the relatively high prices of these drugs provide space for new competitors to launch cheaper alternatives.

Ecnoglutide is administered via weekly injections, and as a GLP-1 receptor agonist, its mechanism of action is to help control blood sugar levels and trigger a feeling of fullness.

Multi-Regional Authorization Layout

In addition to the U.S. market, Xianweida is also negotiating authorization matters for the drug with partners in other regions, including Latin America and the Middle East.

Recently, Xianweida has reached a cooperation agreement with Hk Inno.N, a leading consumer healthcare company in South Korea under the Coma Group, to authorize the Korean product rights of Ecnoglutide to the latter. According to the agreement, Xianweida will receive nearly $60 million in payments, including milestone payments, and will extract double-digit royalties based on net sales during the subsequent commercialization process.

Progress of Application in the Chinese Market

Xianweida has applied to the National Medical Products Administration's Drug Evaluation Center for the sale of Ecnoglutide for weight management and the treatment of type II diabetes. Pan Hai stated that he could not provide a specific estimate for the approval timeline.

Pan Hai pointed out that the pricing in the Chinese market will be consistent with other approved competitors, and the company will not participate in a "price war" in the local market. Currently, weight loss drugs from companies including Novo Nordisk and Eli Lilly have been approved in the Chinese market.

Currently, the phase III clinical trials of Ecnoglutide for diabetes and weight loss in China are nearing completion, and it is expected to submit a market application within the year, potentially becoming the first domestically developed long-acting glucose-lowering/weight loss innovative GLP-1 receptor drug