Another Chinese-developed GLP-1 Weight-loss Drug Goes Global: Domestic Innovations Attract Major International Licensing Deals

　　【Pharmaceutical Network Industry Dynamics】Obesity is one of the pressing health challenges, with a wide range of comorbidities such as type 2 diabetes, cardiovascular diseases, liver diseases, and chronic kidney diseases. Data predicts that by 2035, more than 4 billion people will be affected by obesity or being overweight. Clearly, the market potential for weight-loss drugs is enormous, with forecasts indicating that the global weight-loss drug market size will reach 377.65 billion yuan by 2030.
 

In recent years, with the rapid development of Chinese pharmaceutical companies in the field of weight-loss drugs, innovative drugs have been continuously making their way to the global market. For instance, on December 18, Merck announced that it had signed a deal worth up to $2 billion with China's Hansoh Pharma to develop and commercialize an experimental oral weight-loss drug. Under the agreement, Hansoh Pharma granted Merck the exclusive global license to develop, manufacture, and commercialize HS-10535, a preclinical oral small-molecule GLP-1 receptor agonist.
 

It is reported that Hansoh Pharma's HS-10535 is currently in the preclinical testing phase. Relevant persons from Merck stated that through this agreement, the goal is to leverage the company’s experience in incretin biology to evaluate HS-10535 and explore whether this drug can provide additional cardiometabolic benefits beyond weight loss.
 

Notably, in May this year, Hengrui Pharma licensed the exclusive rights for the development, production, and commercialization of its proprietary GLP-1 product portfolio, including HRS-7535, HRS9531, and HRS-4729, to Hercules CM Newco, Inc. (hereinafter referred to as "Hercules US") for regions outside Greater China. The total value of the licensing deal exceeded 6 billion US dollars, drawing significant attention from the industry. As part of the licensing transaction consideration, Hengrui Pharma will acquire 19.9% of the equity in Hercules US.
 

Among them, HRS-7535 tablets are a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist. It can not only activate human GLP-1R to promote insulin secretion in the pancreas, reduce glucagon secretion, and inhibit gastric emptying, but also enhance satiety and suppress appetite by influencing the central nervous system, directly reducing energy intake through mechanisms used for treating type 2 diabetes mellitus (T2DM) and weight loss. Globally, there are currently no oral small-molecule GLP-1R agonists on the market.
 

HRS9531 Injection is a dual agonist independently developed by Hengrui Pharma, targeting the gastric inhibitory polypeptide receptor (GIPR) and glucagon-like peptide-1 receptor (GLP-1R). It can synergistically promote insulin secretion, suppress energy intake, and improve insulin sensitivity. Additionally, it effectively accelerates lipid metabolism and reduces gastrointestinal adverse reactions caused by GLP-1 through GIPR activation, used for treating type 2 diabetes mellitus (T2DM) and weight loss.
 

In May, Hangzhou Xianweida Bio also announced a collaboration with Hk Inno.N, a subsidiary of South Korean consumer healthcare company Kolmar (Kolmar, KRX:161890), granting Hk Inno.N the rights to Ecnoglutide in South Korea. The latter will be responsible for clinical development and commercialization in the South Korean market.
 

Data show that glucagon-like peptide-1 (GLP-1) agonists can effectively treat type 2 diabetes and obesity, and have shown potential in treating metabolic dysfunction-associated steatohepatitis (MASH). Enotuglutide Injection is a novel long-acting GLP-1 agonist with cAMP bias, optimized to enhance bioactivity and reduce production costs, allowing for once-weekly dosing.
 

In November 2023, AstraZeneca entered into an exclusive agreement with Eternity Bio, potentially worth up to $1.825 billion, to acquire the small molecule GLP-1 receptor agonist ECC5004 (also known as AZD5004) for the treatment of indications including obesity, type 2 diabetes, and other comorbidities.
 

Data show that AZD5004 is a once-daily, low-dose small molecule GLP-1 receptor agonist, which has demonstrated ideal efficacy and safety in preclinical studies. It was reported that in November this year, AstraZeneca announced the latest results of a Phase 1 clinical trial of its investigational oral GLP-1 therapy AZD5004 conducted in obese patients with type 2 diabetes. The data showed that this investigational therapy reduced patients' body weight by 5.8% after four weeks of treatment and improved their blood glucose levels.
 

The industry says that currently, many overseas companies are actively introducing pipelines, among which GLP-1 weight-loss and metabolism-related drugs are a major hot category. In China, with the continuous development of innovative drugs, it will become an important participant in the global weight-loss drug market, which has also attracted more attention and investment from global pharmaceutical companies to the Chinese market.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.