The domestic weight loss track welcomes heavyweight "athletes".
On July 19th, the reporter learned from the National Medical Products Administration that the long-term weight management indication of Eli Lilly's Tilpotide Injection has been approved. This is currently the first and only approved glucose dependent insulinotropic polypeptide (GIP)/glucagon like peptide-1 (GLP-1) receptor activator, and also the first innovative drug approved by Eli Lilly in the field of obesity treatment in China.
Lilly and Novo Nordisk have always been known as the "GLP-1 duo", with the latter possessing the "weight loss miracle drug" semaglutide, which has been approved for market in China. Now, with the addition of Tilpotide to the domestic weight loss track, the two giants will face off head-on in China.
In contrast, the progress of domestic pharmaceutical companies in the GLP-1 field has also received high attention from the market. Players including Hengrui Pharmaceutical, Borui Pharmaceutical, and Ganli Pharmaceutical are accelerating the landing of related products.
Two giants' products have been approved successively
According to Eli Lilly, the approved GIP/GLP-1 receptor dual agonist tilboptin (trade name: Mufengda) will be used for long-term weight management in China. On May 21 this year, Tilpolide was approved in China for use in type 2 diabetes.
Tilpotide injection can bind and activate GIP receptors and GLP-1 receptors, reducing food intake, body weight, and fat mass by regulating appetite.
Lilly and Novo Nordisk have always been known as the "GLP-1 duo", with the latter possessing the "weight loss miracle drug" semaglutide. Moreover, semaglutide had already taken the lead in entering the Chinese market.
As early as January this year, Novo Nordisk's Smeaglutide Tablets (trade name: Novo Nordisk) was approved for marketing in China. This is the first oral GLP-1 receptor agonist approved for marketing in China, but this drug was approved for the treatment of type 2 diabetes at that time.
On June 25th, the National Medical Products Administration approved the marketing application of Novo Nordisk's semaglutide injection (trade name: Novo Nordisk) for long-term weight management in China.
Now, with the approval of Eli Lilly's Tilpotide injection in China, the two giants, Novo Nordisk and Eli Lilly, are officially engaged in a direct competition in the billion yuan GLP-1 market in China.
What are the advantages of [align center] tilboptin?
Although both semaglutide and tiltrotide belong to GLP-1 drugs, the difference is that semaglutide belongs to GLP-1 single target drugs, while tiltrotide belongs to GIP/GLP-1 dual target drugs.
The competition between the two major drugs is directly reflected in their effectiveness. In July of this year, Truveta, a healthcare data company, published a paper in the Journal of Internal Medicine of the American Medical Association stating that after integrating electronic health record information of 18386 obese patients from more than 30 health system databases in the United States, researchers found that after 6 months of treatment, patients treated with tiltrotide lost 10.1% of their body weight, while those treated with semaglutide lost 5.8% of their body weight; After 12 months of treatment, these two numbers were 15.3% and 8.3%, respectively.
A person from a domestic pharmaceutical company involved in the GLP-1 field also told reporters that in the development of GLP-1 drugs, Telbodide, with its dual target design, has shown better weight loss effects in the clinical trial SURMUNT-3. He believes that in comparison, the performance of single target semaglutide in the STEP 1 experiment is relatively average.
However, in terms of global sales, Novo Nordisk is significantly ahead of Eli Lilly by relying on its leading injection of Megaloprid.
Previously, Novo Nordisk's 2023 financial report showed that Wegovy's revenue from Simeglutide Injection for weight management was approximately 41.632 billion Danish kroner (approximately 6.053 billion US dollars), a year-on-year increase of 147%. According to its first quarter report, Wegovy's sales in the first quarter of this year reached 9.377 billion Danish kroner (approximately 1.368 billion US dollars), a year-on-year increase of 106%.
According to the 2023 financial report released by Eli Lilly, the sales revenue of its weight loss drug, Tilpotide, reached $176 million in the first month of its release, and the sales revenue of Tilpotide in the first quarter of 2024 reached $517 million.
However, it should be mentioned that Wegovy was already launched in the United States in 2021, while the weight loss indication for tilpotide was not approved by the FDA until November 2023, and the tilpotide used for weight loss has not yet gone through a full year of sales. According to a research report by Dongwu Securities, the sales growth rate of Tilpotide may be faster than that of Simeglutide.
How are domestic players progressing?
At present, there are 31 GLP-1 drug pipelines in the clinical I/II and later stages in the field of weight loss worldwide, of which 4 drugs have been approved for the treatment of overweight or obesity. As overseas giants' products enter the domestic market one after another, domestic GLP-1 players are also accelerating the launch of their respective products.
At present, there is fierce competition among domestic enterprises in the weight loss track. Among them, Xinda Biotechnology's Masidopeptide has the fastest progress and has applied for listing in China in February 2024. Hengrui Pharmaceutical is also vigorously expanding its GLP-1 drug portfolio, with three drugs currently in the clinical stage.
On June 22nd, Ganli Pharmaceutical also announced the results of a phase Ib/IIa clinical study of its self-developed GLP-1 receptor agonist GZR18 injection in obese/overweight populations in China. After 35 weeks of treatment with GZR18, the weight of the GZR18 QW group decreased by an average of 17.8% compared to baseline, and by 18.6% compared to the placebo group.
Borui Pharmaceutical recently conducted a survey with a total of 104 institutions, providing detailed introductions on the research and development progress, clinical efficacy, future market views, overseas patents, and other aspects of its BGM0504 injection.
In terms of progress, Borui Pharmaceutical completed the approval of BGM0504 injection from clinical trials to phase III clinical research in just 18 months.
In terms of active pharmaceutical ingredients, domestic players have also made rapid progress. Recently, Hanyu Pharmaceutical publicly revealed that its active pharmaceutical ingredient, Tenpo Peptide, has received a DMF registration number from the FDA. In the market competition of the same variety, enterprises and products that obtain DMF registration numbers are easily given priority consideration by customers, which is conducive to the enterprise seizing market opportunities and expanding customers.
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