NEWS

The first domestic GLP-1 receptor agonist for weight loss was approved for listing.

Release time:

2023-07-21 09:46

 

2023Year7Month4On the same day, Huadong Pharmaceutical announced that its wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. has received a drug registration certificate approved and issued by the State Drug Administration, approving the marketing license of liraglutide injection (trade name: lilupin) for weight loss indications. The approved indications for weight loss are mainly for the initial body mass index (BMI)≥30 kg/m2(obese) or≥27 kg/m2(Overweight),accompanied by at least one weight-related comorbidity (e. g., hypertension,2Type 2 diabetes or dyslipidemiaWait) Adult patients.

Liraglutide is a glucagon-like peptide-1(glucagon-like peptide-1,GLP-1)receptor agonist, this receptor agonist is a majorLA hormone produced by cells that belongs to incretin..GLP-1It is a new type of hypoglycemic drug. It enhances insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, thereby achieving the effect of lowering blood sugar; at the same time, it can also delay gastric emptying and reduce food intake through central appetite suppression. Therefore, it can also be effectively used for the treatment of obesity or overweight. Previously, Smeaglutide, who was caught fire by public figures such as Musk, also belongedGLP-1Receptor agonists can be used for diabetes or weight loss indications. Compared with liraglutide, which requires daily injection, semaglutide only needs to be injected once a week, and the weight loss effect reaches that of liraglutide.1.5~3Times. However, at present, simaglutide is only approved for the treatment of diabetes in China, and has not been approved for weight loss indications.

Previously, China and the United States East China to the State Intellectual Property Office on the core patent of Simaglutide (application number.“CN200680006674.6", the name" acylatedGLP-1Compound") filing a request for invalidation;2022Year9In January, the State Intellectual Property Office declared the patent invalid. At present, the patentee Novo Nordisk is appealing, but no result has been found yet. Although the current domestic weight loss market is in short supply of weight loss drugs, it can be predicted that once liraglutide is listed, it will bring huge benefits to East China Medicine. However, based on the previous patent dispute between East China Medicine and Novo Nordisk over selmeglutide, investors and relevant people are also highly concerned about the possible patent risks of liraglutide. In this regard, Huadong Medicine stated that the relevant original research patents of liraglutide have expired or are invalid, so they believe that lirupin does not have intellectual property risks. After a query in the "China Listed Drug Patent Information Registration Platform", Liluping's two registration information are proposed.1The patent statement supports East China Medicine's claim that there is no risk of infringement by Lilupin.