Novo Nordisk and Lilly, the "duopoly" in the field of diabetes, have been breaking their wrists. Industry chain enterprises have gained more development opportunities through continuous product changes.
Compared to Novo Nordisk's Smegglutide, Lilly's Zepbound (Tirzepatide Tilpotide) injection, which is priced lower and has better clinical weight loss effects, was approved for sale on November 8th local time.
The US Food and Drug Administration (FDA) announced on Wednesday that Eli Lilly's Zepbound injection was approved for long-term weight management of adults, applicable to obese or overweight adults (with a BMI of at least 27), and with at least one weight related condition (such as hypertension, type II diabetes or high cholesterol), which needs to be used in combination with a diet that controls calorie intake and increases physical activity.
Tilpolide is the active ingredient in Zepbound, which has been approved under the trade name of Mounjaro to help improve the blood sugar level of adults with type II diabetes.
Lilly stated in its announcement that it expects Zepbound to enter the US market before the end of the year, priced at $1059.87 per month, which is 20% lower than the pricing of its competitor, Meglutide Injection. For patients with commercial insurance, the minimum monthly expenditure can be reduced to $25.
After the announcement, Lilly's stock price rose 3.2%, with a market value of $587.745 billion, approaching the $600 billion mark.
In addition, Lilly has also submitted an application for the weight loss indication listing of ticapatide in China, which is currently under review.
It is worth noting that the terminal reference price of Ticlopramide is $1060 per month, which is 20% lower than the Wegovy (indication product name of Smegglutide) of Pinot and Nord. This is very rare in the history of innovative drugs in the United States.
Some industry insiders believe that it may be because Novo Nordisk, as a European company, needs to spend more effort to secure channels to compete with a local American company in the US market.
However, after the approval and pricing of Tiapatide's weight loss indication, Novo Nordisk's stock price did not decline, either because the market is still in a state of supply and demand imbalance.
According to the three quarter report data released by the previous two companies, Novo Nordisk's total revenue in the first three quarters was DKK 166.398 billion (approximately USD 24.171 billion), a year-on-year increase of 29%. The revenue of diabetes and obesity care business was DKK 153806 million (US $22.342 billion), up 36% year on year. Among them, Wegovy (for weight loss indications) received DKK 21.729 billion (approximately USD 3.086 billion) in revenue, a significant increase of 481%.
As a star product, Smeglutide has already supported half of Novo Nordisk's market. Based on the performance of the first three quarters, Novo Nordisk has raised its annual sales and operating profit growth expectations. The company has adjusted its sales growth forecast to a growth of 32% -38%, and its operating profit increase forecast to a growth of 40% -46%.
Lilly's total revenue in the first three quarters was $24.771 billion, a year-on-year increase of 17%. Among them, the revenue in the third quarter was $9.499 billion, a year-on-year increase of 37%, mainly driven by the rapid release of the GLP-1R/GIPR dual target agonist Mounjaro (Tirzepatide). The sales in the third quarter were $1.409 billion, an increase of 43.8% compared to the second quarter.
One generation is stronger than the other
Since its inception, GLP-1 products have always been stronger than the first generation.
After Lilly launched Baimida, Novo Nordisk made Liraglutide; Lilly immediately launched Dulaglutide, and Novo Nordisk also made Smeglutide; Nowadays, Lilly's Tippatide has been widely produced.
There is a saying in the industry that "Novo Nordisk and Lilly, the 'duopoly' in the field of diabetes, have been fighting each other."
From the weight loss figures that the public is most concerned about, the liraglutide group lost an average of 8% of weight at 56 weeks. Smeglutide doubled this number and announced an average weight loss of 16% at 68 weeks. Next, the answer given by Tippatide is: lose more than 20% of weight.
The industry chain boom of GLP-1
GLP-1 was originally only hoped for by scientists to reduce blood sugar, but unexpectedly entered the weight loss track and has also shone brightly in fields such as kidney damage and non-alcoholic steatohepatitis.
The emergence of GLP-1 is changing traditional obesity treatment.
According to Insight database statistics, there are currently 27 clinical research projects targeting GLP-1 obesity treatment drugs worldwide, with a total of 289 drugs targeting GLP-1R (including preclinical to approved marketing), including 149 drugs in China, accounting for more than half of the total. The 20 fastest developing GLP-1 drugs in China, of which 8 only target GLP-1R, and the remaining 12 are all composite multi target drugs of GLP1R, GIPR, and GCGR.
Competition pattern of domestic long-acting dual/multi target GLP-1 drugs (clinical and above, as of September 23, 2023) Source: Medical Rubik's Cube, Debang Securities Research Institute
Domestic competition pattern of GLP-1 biologically similar drugs (clinical phase III and above, as of September 23, 2023) Source: Medical Cube, Debang Securities Research Institute
At present, GLP-1 drugs are highly competitive in China. In addition to multiple companies developing similar drugs such as Liraglutide and Smeglutide, the research and development layout of weight loss drugs in China still focuses on GLP-1 single targets, with the first being Dahua XW003, Tianjing Biotech/Shiyao Group TG103, Ganli Pharmaceutical GZR18, Hongyun Huaning Geluta monoclonal antibody, and Paige Biotech/Tianshili polyethylene glycol based exenatide. Currently, the research and development progress is at the forefront of the domestic industry.
Some companies with a deep layout in this field are laying out dual targets such as GLP-1/GIP, GLP-1/GCGR, and even three targets, seeking differentiated competition. Xinda Biologics Masidu Peptide was expected to apply for listing from the end of 2023 to the beginning of 2024. Hengrui Pharmaceuticals HRS9531, Dongyangguang Pharmaceuticals HEC88473, Borui Pharmaceuticals BGM0504, Zhongsheng Pharmaceuticals RAY1225, and others have also made relatively advanced clinical progress.
"Pop ups" Bring Carnival to the Industry Chain
The "popular" GLP-1 has also sparked widespread attention and investment in the peptide industry chain in the pharmaceutical and health industry.
Situation of raw materials for Smegglutide in China
Several companies have also disclosed in their announcements that they are benefiting from the high visibility of the industry.
According to the third quarter report of WuXi KangDe, the company's TIDES business (mainly oligonucleotides and peptides) continues to increase in volume. In the first three quarters of 2023, TIDES business revenue reached RMB 2.07 billion, a strong year-on-year growth of 38.1%. The company expects TIDES business revenue to increase significantly in the fourth quarter, exceeding 60% for the entire year. As of the end of September 2023, TIDES business has seen a year-on-year increase of 245% in orders in hand.
During the roadshow, Kailaiying stated that from the supply side, there is a large demand for production capacity in the entire industry and there are commercial opportunities. While completing the projects in hand, the company is also actively expanding commercial projects. The company has served relevant varieties that are leading in clinical progress in the domestic market, and some projects have entered the validation production phase. Given the lack of production capacity in this field, the company has made a prediction to deploy new production capacity in advance and actively strive for global orders. It is expected that by the first half of 2024, the total production capacity of solid-phase synthesis will reach 10000L, which can meet the commercial production demand of solid-phase peptides at the level of one hundred kilograms.
Jiuzhou Pharmaceutical revealed in its investor relations event that the peptide business is the focus of the company's future new business development. Currently, it has established a peptide research and development center in Ruibo Hangzhou, and the Ruibo Suzhou peptide GMP pilot plant has been opened and has undertaken business. At the same time, the Ruibo Suzhou Peptide Commercialization Workshop is under construction. Peptide clients include both overseas large pharmaceutical companies and domestic pharmaceutical companies, with most projects in the early or clinical stages, mainly focusing on raw material drug projects.
In addition, GLP-1 related concepts have also been continuously sought after in the secondary market.
This morning, the sugar substitute sector strengthened in the early trading session, with Bowling Treasure rising its limit and Sanyuan Biotechnology up 6%. Bailong Chuangyuan, Rhine Biotechnology, Jiahe Food and others followed suit.
On the news page, Bowling Treasure stated on the interactive platform that there are research reports showing that taking D-aloxose can promote the release of GLP-1 and affect the vagal afferent nerve through GLP-1 receptor signals, inhibiting appetite and hyperglycemia, and the effect is related to the time of intake. Currently, it is still in the research stage.
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