GLP-1/GIP Dual-Agonist Therapeutics Attract Intense Global and Domestic R&D Competition

　　【Pharmaceutical Network Industry Dynamics】Currently, GLP-1 drugs have become a very popular field, primarily targeting type 2 diabetes and obesity for development. Moreover, multinational pharmaceutical companies like Boehringer Ingelheim are actively exploring new indications, such as for Metabolic Dysfunction-Associated Steatohepatitis (MASH).
 

As GLP-1 drugs gain significant attention, pharmaceutical companies both in China and abroad are competing to establish their presence. In China, recent progress updates on domestically produced GLP-1 drugs, including GLP-1/GIP dual receptor agonists, have continuously drawn industry focus and discussion.
 

On April 24, Tonghua Dongbao Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., had received the clinical trial approval notice for the weight-loss indication of the injectable THDBH120 from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The injectable THDBH120 is a dual-target agonist of glucagon-like peptide-1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor, and its diabetes indication has entered the Phase Ia clinical research stage.
 

According to reports, Tirzepatide, the world's first GLP-1/GIP dual receptor agonist developed by Eli Lilly, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2022 for its diabetes indication (brand name: Mounjaro), and its weight loss indication (brand name: Zepbound) received FDA approval in November 2023. Currently, Tirzepatide has not been approved for any indications in China, and the marketing application for its diabetes indication was accepted by the National Medical Products Administration in September 2022.
 

On the evening of April 22, Huadong Medicine announced that following its approval for clinical trials in China in March, the clinical trial application for its GLP-1/GIP dual-target new drug HDM1005 injection has been approved by the U.S. FDA, allowing Phase I clinical trials to be conducted in the United States. It is reported that the drug's clinical trial in China was approved by the National Medical Products Administration in March 2024, with indications for type 2 diabetes and weight management in overweight or obese populations.
 

In April, information on the CDE website also revealed that Jiuyuan Gene submitted the first domestic application for the marketing approval of Semaglutide Injection in China, which has been officially accepted by the National Medical Products Administration (NMPA). Reportedly, the competition for biosimilar Semaglutide in China is becoming increasingly intense. Currently, multiple companies have entered the phase III clinical stage, including Jiuyuan Gene, Huadong Medicine, Bowei Biotech, Sihe Pharmaceutical, United Laboratories, Qilu Pharmaceutical, Lizhu Group, and CSPC.
 

On February 7, Innovent Bio's GLP-1/GCG dual receptor agonist Mastytide, licensed from Eli Lilly, had its first New Drug Application (NDA) accepted by the CDE for long-term weight control in adult patients with obesity or overweight. It is expected to be launched in China in the first half of 2025.
 

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According to industry statistics, apart from Eli Lilly's already marketed tirzepatide, there are over ten GLP-1/GIP dual-target agonists globally that have entered the clinical stage. Among them, the fastest domestically developed candidates are in Phase II clinical trials, with companies such as BrightGene Bio-Medical, Jiangsu Hengrui Medicine, and Shengdi Biopharma leading the research.
 

While domestic pharmaceutical companies are increasingly focusing on the GLP-1 drug market, investors are also showing interest in related companies. On April 26, Synbio Technologies released a record of investor relations activities, stating regarding the question raised by institutions about "the company's layout of GLP-1 products" that its GLP-1 products under research include liraglutide.API (Active Pharmaceutical Ingredient)Including injections, semaglutide API and injections, tirzepatide API and injections. The company's CDMO business provides peptide innovative drug development services to customers both in China and internationally, among which four GLP-1 products have entered the clinical stage.
 

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