The Milestone in the Journey of Domestic Weight Loss Drugs: Hengrui's Breakthrough!

2024-05-11

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In recent news from Yaozh.com, Hengrui Pharmaceuticals, a leading player in the pharmaceutical industry, has taken a significant step forward in the development of domestic weight loss drugs. With the initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist GIPR dual agonist, HRS9531, intended for obesity treatment, Hengrui aims to complete the study by July 2025. This move comes amidst the submission of a market application for a GLP-1R/GCGR dual agonist, Masidupeptide, by Xinda Biotechnology, positioning it as a potential pioneer in the field of domestically produced dual-target weight loss drugs.

Hengrui Pharmaceuticals: Pioneering Innovations

Hengrui Pharmaceuticals has established a strong presence in the field of metabolic disorders, including diabetes and obesity, in addition to their focus on oncology. With nine innovative drug pipelines dedicated to metabolic diseases, Hengrui has developed a range of drugs targeting various points such as DPP-IV, metformin, SGLT2, and insulin/GLP-1. Notably, three of their pipelines involve GLP-1 targeting, including HR17031, a drug for type 2 diabetes, and two promising GLP-1 weight loss drugs, HRS-7535 and HRS9531.

The GLP-1 weight loss drug market is highly competitive, with newcomers needing to demonstrate distinctive advantages to gain market share from established giants like Lilly and Novo Nordisk. Hengrui's strategy involves developing an orally administered small molecule GLP-1 receptor agonist GLP-1 receptor agonist, HRS-7535. This formulation offers improved portability and ease of use compared to injectable forms, enhancing patient compliance. Furthermore, HRS-7535 holds the advantage of being the first oral small molecule GLP-1 drug without any existing global competitors. Currently, HRS-7535 is in Phase II clinical trials for both type 2 diabetes and weight loss indications. Initial results from Phase I studies indicate its favorable safety, tolerability, pharmacokinetic profile, and potential to reduce weight by 4.38 kg after four weeks of treatment, with notable hypoglycemic effects.

Xinda Biotechnology: The Dual-Target Approach

Xinda Biotechnology has taken a significant stride in the development of dual-target weight loss drugs with its GLP-1R/GCGR dual agonist, Masidupeptide. Having received acceptance for market application by the National Medical Products Administration (NMPA) in February of this year, Masidupeptide is poised to become the first domestically produced dual-target weight loss drug. The results from Phase II clinical studies demonstrate an average percentage change in weight reduction of -15.4% compared to the placebo group, with a weight loss of 14.7 kg after 24 weeks of treatment. In clinical studies primarily conducted on the Chinese population, Masidupeptide has shown superior weight reduction efficacy (18.6%) compared to Lilly's dulaglutide and Novo Nordisk's semaglutide.

Hengrui's HRS9531: A Promising Contender

Following closely behind Xinda Biotechnology, Hengrui Pharmaceuticals has initiated Phase III clinical trials for their GLP-1R/GIPR dual agonist GIPR dual agonist, HRS9531, designed for obesity treatment. The study is expected to be completed by July 2025. Initial results from Phase I studies indicate weight reductions ranging from 4.3-7.7 kg (6.7%-9.3%) after four weeks of treatment with HRS9531 at doses ranging from 0.9-5.4 mg. The greatest weight reduction (8.0 kg, 10.0%) was observed on the 36th day in the 5.4 mg dose group. Although Hengrui's research and development progress slightly lags behind Xinda Biotechnology, their strong sales and marketing capabilities make the ultimate sales performance of these two contenders difficult to predict.

The Competitive Landscape for Domestic Players

Time is of the essence for domestic pharmaceutical companies in the Chinese market. Both Novo Nordisk's semaglutide and Lilly's dulaglutide, with weight loss indications, have already submitted market applications and are expected to be approved for sale in the near future, setting the stage for intense competition in the GLP-1 weight loss drug market. Moreover, there is a significant level of competition among domestic players in this field. Dozens of GLP-1 pipelines are currently in various stages of clinical development. Apart from Xinda Biotechnology and Hengrui Pharmaceuticals, other listed pharmaceutical companies, such as Huadong Medicine, Hanson Pharmaceutical, and Borui Medicine, are alsoactively pursuing the development of GLP-1 weight loss drugs.

The race to develop domestically produced weight loss drugs in China has reached a critical milestone with Hengrui Pharmaceuticals' initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531. Alongside Xinda Biotechnology's market application for their GLP-1R/GCGR dual agonist, Masidupeptide, the domestic weight loss drug market is poised for intense competition. Hengrui's innovative pipeline, including the orally administered GLP-1 receptor agonist GLP-1 receptor agonist, HRS-7535, showcases their commitment to providing patients with effective and convenient treatment options. However, success in this market will depend on factors such as production capacity, marketing strategies, and ongoing research and development efforts. As the journey progresses, various domestic pharmaceutical companies, including Hengrui and Xinda, are taking significant steps forward, aiming to claim their share of the weight loss drug market and improve the health and well-being of individuals struggling with obesity.