On November 8th local time, American pharmaceutical giant Lilly announced that its GLP-1R/GIPR dual target agonist, Tilposide Injection Zepbound, has been approved by the US Food and Drug Administration for weight loss indications. Lilly stated that Zepbound is expected to be launched in the United States by the end of this year, with a total of six doses priced at $1059.87, which is about 20% lower than the selling price of Novo Nordisk Wegovy (the weight loss drug Smegglutide for weight loss indications).
Since the beginning of this year, two major pharmaceutical giants, Lilly and Novo Nordisk, have been constantly competing on the GLP-1 (glucagon like peptide-1) track. The results of the three quarter reports of the two companies have reached new heights, once again igniting market attention to GLP-1 drugs. In the first three quarters, the sales of Novo Nordisk weight loss drug Wegovy reached DKK 21.729 billion, a year-on-year increase of 481%; Lilly's GLP-1/GIP dual receptor agonist, Tilposide, also had quarterly sales exceeding $1.4 billion, a 44% increase compared to the previous quarter.
With its huge market potential in the field of reducing blood sugar and weight loss, GLP-1 has also attracted a large number of leading domestic pharmaceutical companies to enter the market. According to Insight data, multiple pharmaceutical companies, including Hanyu Pharmaceutical, Haizheng Pharmaceutical, Aimike, Hengrui Pharmaceutical, and Lizhu Group, have established their presence.
In an interview with a reporter from Securities Daily, a person from the Hanyu Pharmaceutical Board Secretary Office responded to the latest developments in the main production lines: "Lilly's approved telposide is still in the research and development pipeline and has not yet entered clinical practice." As soon as it enters clinical practice, the person stated that after submitting clinical applications in China, the time will still be determined based on the approval of the National Drug Administration, but the company will actively promote it. In terms of Simeglutide, the company's application for clinical trial registration of related injections has been accepted by the National Drug Administration, and the raw materials have been registered with the DMF in the United States. Currently, the company focuses on the market approval of formulations and domestic clinical trials. Liraglutide has entered the final stage of listing, and recently obtained the first commercial batch purchase order of approximately RMB 103 million from the US partner
The person further stated that in the future, research and development will continue to be synchronized through multiple pipelines, and new products will be launched in a tiered manner. The company has always attached great importance to R&D investment. Based on the short, medium, and long-term R&D layout, the number of R&D personnel can support the parallel operation of multiple projects. In the first three quarters, Hanyu Pharmaceutical's R&D investment reached a total of 118 million yuan, a year-on-year increase of 15.3%, accounting for 29.41% of revenue.
In addition, the US FDA has completed on-site inspections of multiple production bases of the company. Hanyu Pharmaceutical previously stated on the investor interaction platform that its Longhua headquarters laboratory has successfully completed a review by the US FDA and achieved excellent NAI (zero defects, no action required) inspection results. At this point, the company has completed on-site inspections of the Pingshan Preparation Production Base, Wuhan API Production Base, and Longhua Headquarters Laboratory, and has obtained an on-site inspection report (EIR) from the US FDA for the Pingshan Branch. Each production base has successively obtained FDA approval from the United States, which is conducive to accelerating the approval process of the company's declared ANDA (New Drug Application) products in the United States.
The relevant personage of Lizhu Group told the reporter of Securities Daily: "The company's Smeaglutide is still in research and development and has not yet been listed." The company revealed its detailed progress in recent research: its Smeaglutide's diabetes indication has completed Phase III clinical enrollment, and it is expected to get the clinical report in the first quarter of next year and strive to report to production as soon as possible. In terms of process route, the company's Smegglutide adopts biological fermentation method, rather than chemical synthesis. In terms of production capacity, considering the huge market demand, there are more than 100 million people with diabetes in China. In addition, the market demand for weight loss indications is wider. The company will make reasonable production capacity planning according to the actual situation in the future, and currently plans to reserve 20 million to 40 million doses; In terms of weight loss indications, the company expects to submit a clinical IND (new drug clinical trial) application for the weight loss indications of smeglutide in December.
According to the Insight database, there are currently 112 GLP-1 new drugs entering the clinical stage in China, among which companies such as Huadong Pharmaceutical, Renhui Biology, and Hengrui Pharmaceutical are at the forefront of progress. In the first half of 2023, a total of 16 GLP-1 drug projects were declared for clinical trials, which is close to the total declared amount for the entire year of 2022.
In March of this year, the latest version of the World Obesity Atlas 2023 released by the World Obesity Alliance predicted that by 2035, more than 4 billion people worldwide will be obese or overweight, accounting for 51% of the global population. The adult obesity rate in the United States is expected to reach 58% by 2035, with an annual growth rate of 2.1% from 2020 to 2035; The adult obesity rate in China is expected to reach 18% by 2035, with an annual growth rate of 5.4% from 2020 to 2035. The cost of overweight/obesity management is expected to reach 3.1% of GDP by 2035. Standing on this blue sea and competing with the leading "duo", Chinese pharmaceutical companies are racing.