The first GLP-1 receptor agonist used for weight loss in China has been approved for marketing

On July 4, 2023, Huadong Medicine announced that its wholly-owned subsidiary Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd. had received the drug registration certificate approved and issued by the National Medical Products Administration, which approved the marketing license of Liraglutide injection (trade name: Liluping) for weight loss indications. The approved weight loss indications are mainly for adult patients with an initial body mass index (BMI) of ≥ 30 kg/m2?(obesity) or ≥ 27 kg/m2?(overweight) and at least one weight related complication (such as hypertension, type II diabetes or Dyslipidemia).

Liraglutide is a glucagon like peptide-1 (GLP-1) receptor agonist. This receptor agonist is a hormone mainly produced by intestinal L cells and belongs to incretins. GLP-1 is a new type of hypoglycemic drug. It increases insulin secretion in a glucose concentration dependent manner, inhibits glucagon secretion, and thus reduces blood sugar; At the same time, it can also delay gastric emptying and reduce food intake through central appetite inhibition, making it effective for the treatment of obesity or overweight. Previously, semaglutide, which was ignited by public figures such as Musk, was also a GLP-1 receptor agonist and could be used for diabetes or weight loss indications. Compared with the daily injection of Liraglutide, semaglutide only needs to be injected once a week, and the weight loss effect is 1.5~3 times of liraglutide. However, semaglutide is only approved for the treatment of diabetes in China, and has not been approved for the indication of weight loss.

Previously, Zhongmeihuadong Pharmaceutical Co., Ltd filed an invalidation request with the China National Intellectual Property Administration for the core patent of Semaglutide (application number: "CN200680006674.6", name: "acylated GLP-1 compound"); In September 2022, the China National Intellectual Property Administration announced that the patent was invalid; At present, the patentee Novo Nordisk is appealing, and there is no result so far. Although the current domestic weight loss market is in short supply of Anti-obesity medication, it can be predicted that once liraglutide is listed, it will bring huge benefits to Huadong Medicine. However, based on the previous patent dispute between Huadong Medicine and Novo Nordisk about Semaglutide, investors and relevant persons are also highly concerned about the possible patent risks of Liraglutide. In this regard, Huadong Medicine said that the relevant original patents of liraglutide had expired or were invalid, so they believed that there was no intellectual property risk in Liluping. Through the query on the Patent Information Registration Platform for Listed Drugs in China, Liluping's two registration information proposed a Class 1 patent declaration, which corroborated Huadong Medicine's statement that there was no infringement risk for Liluping.